QSE 4 — Suppliers and Customers

Key Concepts

Key Concepts: This QSE describes the need for agreements between the organization and its suppliers and customers. The agreements define expectations between both parties and measures taken when one entity fails to meet the expectations of an agreement.

Key Terms
Agreement: A contract, order, or understanding between two or more parties, such as between an organization and one of its customers.

Agreement Review: Systematic activities carried out before finalizing the agreement to ensure that requirements are adequately defined, free from ambiguity, documented, and achievable.

Customer: The receiver of a product or service. A customer may be internal (eg, another organizational unit within the same organization) or external (eg, a patient, client, donor, or another organization).

Qualification (materials): For materials that come into contact with the product, verification that the materials are sterile, the appropriate grade and suitability for the intended use and, whenever possible, approved for human use by the United States Food and Drug Administration (FDA) or relevant Competent Authority.

Quality: Characteristics of a product or service that bear on its ability to fulfill customer expectations. The measurable or verifiable aspects of a product or service that can be used to determine if requirements have been met.

Quality Control: Testing routinely performed on materials and equipment to ensure their proper function.

Supplier: An entity that provides a material, product, or service.

Supplier Qualification: Evaluation of a potential supplier to assess its ability to consistently deliver products or services that meet specified requirements.

Examples of Objective Evidence:

• Policies, processes, and procedures related to this chapter.
• Processes for defining and updating or changing agreements.
• Process for recording verbal agreements, if practiced.
• Agreement records.
• Agreement review records.
• Supplier qualification records.
• Supplier evaluation records.
• Supplier selection process.
• Evidence of action taken when a supplier fails to meet expectations, if applicable.
• Evidence of receipt of product(s) as stipulated in agreements.
• Records of inspection and testing.

4.0 Suppliers and Customers

The organization shall ensure that agreements to provide or receive products or services are reviewed, approved, and meet supplier and customer expectations.

Guidance

The committee added standard 4.0 to mirror all other AABB Standards and to match the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and maintain a list of all current suppliers and customers with contact information.
• Establish and document criteria for selecting and evaluating suppliers.
  • Conduct and document regular supplier evaluations based on performance and compliance.
• Create and maintain agreements with suppliers and customers, ensuring they are reviewed and approved by authorized personnel.
• Implement a process to review and approve all agreements before execution.
• Regularly review and update agreements to ensure they meet current expectations and standards.
• Document any changes to agreements and communicate them to relevant stakeholders.

4.1 Supplier Qualification

[Cord blood applicable]

The organization shall evaluate the ability of suppliers of critical materials, equipment, and services to meet specified requirements.

Guidance

Distributed manufacturing or shared services of any step from donor selection through final product disposition should undergo sufficient review to determine that the supplier of such services is qualified to meet the quality expectations of all involved facilities and within the expectations of these CT Standards. A way to meet the intent is that facilities may use the same policies and procedures for the qualification of vendors or suppliers of other critical materials to document the qualification of service providers or joint manufacturers. For example, if a manufacturer uses another facility or department for testing, that entity may be qualified using the manufacturer’s vendor qualification process and documented as such. (SS)

The committee added standard 4.1 to mirror all other AABB Standards and to match the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for supplier qualification, including criteria for evaluating suppliers of critical materials, equipment, and services.
  • Include procedures for initial and ongoing evaluation of suppliers.
  • Specify documentation requirements for supplier evaluations.
• Create a supplier qualification form or checklist to document evaluations.
• Maintain a current list of qualified suppliers, including their evaluation status and review dates.
• Conduct and document regular reviews of supplier performance and compliance with specified requirements.
• Implement a process for addressing and documenting any issues or deviations identified with suppliers.
• Ensure all personnel involved in supplier qualification are trained and their competency evaluated regularly.

4.1.1

The organization shall evaluate and participate in the selection of suppliers. If executive management is not included in the selection process, there shall be a mechanism to provide feedback to management with contracting authority.

Guidance

The committee added standard 4.1,1 to mirror all other AABB Standards and to match the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for supplier evaluation and selection.
  • Include criteria for evaluating suppliers based on quality, reliability, and compliance.
  • Define roles and responsibilities for the supplier selection process.
• Establish a supplier evaluation form or checklist to document assessments.
• Create a feedback mechanism for communicating supplier performance to executive management.
  • Schedule regular reviews of supplier performance with management.
• Maintain records of all supplier evaluations and decisions in a supplier log.
• Conduct regular audits of suppliers to ensure ongoing compliance with standards.
• Document any deviations or issues with suppliers and implement CAPAs as necessary.

4.1.2

When a supplier fails to meet specified requirements, it shall be reported to the management with contracting authority.

Guidance

The committee added standard 4.1.2 to mirror all other AABB Standards and to match the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Establish an SOP for reporting supplier non-conformance to management.
  • Include criteria for identifying supplier failures.
  • Define roles responsible for reporting and documentation.
• Create a Supplier Non-Conformance Report form.
  • Ensure it captures details of the failure, impact, and corrective actions.
• Maintain a log of all supplier non-conformance reports.
  • Review and update regularly to track trends and resolutions.
• Conduct training for staff on identifying and reporting supplier issues.
  • Document training attendance and competency evaluations.
• Schedule regular management reviews of supplier performance.
  • Include discussions on non-conformance reports and supplier reliability.
• Implement a CAPA process for addressing supplier-related issues.
  • Document all corrective and preventive actions taken.

4.1.3

When cellular therapy product services involve more than one facility, each facility shall be qualified to perform the scope of activities defined in the agreement in accordance with these CT Standards.

☑ Actionable Checklist

• Verify that all facilities involved have current qualifications and certifications.
  • Maintain a log of qualifications and certifications for each facility.
• Develop and maintain agreements that clearly define the scope of activities for each facility.
  • Review and update agreements annually or as needed.
• Conduct an initial qualification audit for each facility to ensure compliance with CT Standards.
  • Document findings and corrective actions in audit reports.
• Establish a process for ongoing monitoring of each facility’s compliance with CT Standards.
  • Schedule regular audits and reviews.
• Ensure all agreements include a clause for periodic review and requalification of facilities.
• Maintain records of all communications and agreements with each facility.

4.2 Agreements

[Cord blood applicable]

Agreements and any incorporated changes shall be reviewed and communicated.

Guidance

Agreements, in some form, should exist between the facility and the suppliers of critical equipment, materials, or services. These agreements should contain sufficient and current information that can satisfy the level of quality and compliance expectations of each party. Agreements include written contracts, purchase orders, and verbal commitments. The facility should determine which agreements should be in writing or in the form of a legal contract. Agreements to provide materials or services must be reviewed to ensure that each party’s expectations are defined. Agreements can be between two separate organizations
or individuals or between separate departments within a single organization.

This standard does not require that all agreements be formal written agreements. It does, however, require that there be a system in place to verify and document a customer’s requirements. The facility is required to ensure that critical materials that are acquired and incorporated into its facility products are acceptable. Acquired products include those that are purchased, donated, or otherwise acquired. They include, but are not limited to, instruments, disposables, and anticoagulant solutions. Examples of services include equipment calibration, equipment, and preventive maintenance. (SS)

The committee revised standard 4.2 to mirror all other AABB Standards and to match the AABB Quality System Essentials.  (SC)

☑ Actionable Checklist

• Review all existing agreements with suppliers and customers to ensure they meet current compliance and quality expectations.
  • Document the review process and any findings in the Agreements Review Log.
• Establish a system to verify and document customer requirements for critical materials and services.
  • Use the Customer Requirements Verification Form to capture and track requirements.
• Ensure that all critical materials acquired are acceptable and meet facility standards.
  • Maintain a Critical Materials Acceptance Log to document compliance.
• Communicate any changes in agreements to all relevant parties promptly.
  • Use the Agreement Change Notification Form to document and track communications.
• Conduct regular audits of agreements to ensure continuous compliance with AABB standards.
  • Schedule and document these audits in the Internal Audit Schedule.

4.2.1

[Cord blood applicable]

Agreements shall be reviewed at defined intervals to ensure that the terms of the agreement continue to meet requirements.

☑ Actionable Checklist

• Establish a schedule for periodic review of supplier and customer agreements.
  • Include this schedule in the relevant SOP.
• Assign responsibility for agreement reviews to specific personnel.
  • Document this responsibility in job descriptions or SOPs.
• Create a standardized form or checklist for agreement reviews.
  • Ensure it includes criteria to assess compliance with current requirements.
• Maintain a log of all agreement reviews, including dates and outcomes.
• Document any changes made to agreements and obtain necessary approvals.
• Conduct training for staff involved in agreement reviews on the review process.

4.2.1.1

This review shall occur at a minimum of every 2 years.

Guidance

The committee new standard 4.2.1.1 to ensure that all agreements are reviewed at least once during every accreditation cycle at a minimum. (SC)

☑ Actionable Checklist

• Schedule a biennial review of all supplier and customer agreements.
  • Use a calendar reminder system to track review dates.
• Develop an SOP for conducting agreement reviews, including criteria and responsible personnel.
• Maintain a log of all agreements with last review dates and next scheduled review.
• Document the outcome of each agreement review, including any changes or actions required.
• Ensure that all reviewed agreements are signed and dated by authorized personnel.
• Conduct training for staff involved in agreement reviews to ensure understanding of the process.

4.2.2

Changes to agreements shall be communicated to affected parties.

Guidance

The committee revised standard 4.2.2 to mirror all other AABB Standards and to match the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Establish a process for reviewing and approving changes to agreements.
  • Document the review and approval process in an SOP.
• Identify all affected parties for each agreement change.
  • Maintain a current list of stakeholders for each agreement.
• Communicate changes to agreements to all affected parties.
  • Use a standardized form or template for communication.
• Obtain acknowledgment of receipt and understanding from affected parties.
  • Keep records of acknowledgments in a dedicated log.
• Review and update the communication process annually.
  • Document any improvements or changes in the process.

4.2.3

[Cord blood applicable]

The responsibilities for activities covered by these CT Standards when more than one organization is involved shall be specified by agreement.

Guidance

The committee revised standard 4.2.3 to mirror all other AABB Standards and to match the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and maintain agreements with all organizations involved in activities covered by CT Standards.
  • Ensure agreements clearly specify responsibilities for each party.
  • Review agreements annually and update as necessary.
• Create an SOP for establishing and maintaining agreements with external organizations.
• Document all agreements in a centralized log for easy access and review.
• Conduct regular audits to verify compliance with agreements.
• Include agreement reviews in management review meetings to ensure alignment with organizational goals.

4.2.3.1

Before acceptance of a documented verbal or written agreement, the agreement shall be reviewed by all involved parties to ensure that:

1. The customer’s requirements are adequately defined in compliance with these CT Standards and in accordance with applicable FDA or relevant Competent Authority requirements.
2. Any differences between the agreement requirements and the cellular therapy products or services offered under the agreement are resolved.
3. The facility has the capability to meet the requirements detailed in the agreement.
4. Chain of identity is maintained.
5. Chain of custody is maintained.
6. Cellular starting material or product quality is maintained under the scope of activities covered by the parties’ agreement per specified requirements.
7. Conformance with accepted policies and procedures is maintained.
8. Conformance with safety requirements is maintained.

Guidance

The committee edited the opening clause of standard 4.2.3.1 replacing the clause, “…the facility or department” with “..all involved parties…” recognizing that this standard applies to more than just a facility or department. (SC)

#4 - Chain of identity is a critical element of patient safety. Most products undergo handoffs, for example, between departments and/or facilities, during manufacturing, and before final product labeling. Labeling provides traceability of the identity across manufacturing steps, and therefore steps to meet acceptable labeling practices should be defined in any agreements. An example of compliance could be that the initial product container is labeled with key identifiers that link the container and its contents and the donor. Labeling may also include the identity of the intended recipient. Chain of identity encompasses all the actions and steps required to transfer this information at each change of container or new labeling step. (SS)

#5 - Chain of custody is a critical element of patient safety. Because most products undergo handoffs during manufacturing and before final disposition, it is essential to have documentation of who was in possession of the product, from collection, through manufacturing, during storage, and until transfer or final disposition (administration or discard). An example of compliance is having agreements that define the roles and responsibilities for ensuring conformance with these CT Standards while serving as the custodian for the product, and documentation that allows for traceability of the product at any given time. (SS)

#6 - In subnumber 6 the committee expanded the content to recognize that there is space in agreements that are beyond origin to administration or discard. (SC)

#8 - Agreements may be between facilities, departments within a facility, or even between two laboratories in the same department. As an example of the latter, the processing laboratory may send bacteria testing to the microbiology laboratory in the same department. (SS)

☑ Actionable Checklist

• Review and document customer requirements in compliance with CT Standards and applicable FDA or Competent Authority requirements.
  • Use a standardized form to capture and verify customer requirements.
• Resolve any discrepancies between agreement requirements and offered products/services.
  • Document resolution steps in a deviation log if discrepancies arise.
• Verify facility capability to meet agreement requirements.
  • Conduct a gap analysis against current capabilities and document findings.
• Ensure chain of identity is maintained through all process steps.
  • Implement SOPs for labeling and traceability at each handoff.
• Ensure chain of custody is maintained with clear documentation.
  • Use a custody log to track product possession from collection to final disposition.
• Maintain product quality as per agreement specifications.
  • Conduct regular quality checks and document results in quality records.
• Ensure conformance with accepted policies and procedures.
  • Map SOPs to agreement requirements using a crosswalk document.
• Maintain conformance with safety requirements.
  • Include safety checks in regular internal audits and document findings.

4.2.3.2

Agreements shall define and describe the following:

4.2.3.2.1

Roles and responsibilities of key personnel.

4.2.3.2.2

Roles and responsibilities of each party involved in the procurement, processing, labeling, storage, distribution, or administration of a cellular therapy product to maintain the chain of identity and chain of custody.

4.2.3.2.3

Communication of critical information, including deviations, nonconformances, and adverse events, and changes in facility status. Standards 1.9 and 5.5 apply.

Guidance

The committee elected to edit standard 4.2.3.2.3 by including the clause, “…and changes in facility status” for parallel construction with the creation of new standard 1.9. (SC)

4.2.3.2.4

Reporting of adverse events and nonconformances to regulatory bodies, Competent Authorities, and registries, if applicable.

4.2.3.2.5

Specifications and requirements for donor and patient care, quality, safety, and other facility-defined critical parameters.

Guidance

These agreements should contain sufficient and current information to satisfy the level of quality and compliance expectations of each party. They should, at minimum, include the personnel identified in Standard 1.0. A way to meet the intent of the standard would be to provide the names and contact information of those with decision-making authority as part of the agreement or associated document. For example, the agreement should provide 1) clear instructions or directives for donor and patient care, 2) product collection parameters, 3) manufacturing requirements, 4) instructions for how to determine if an event is subject to reporting to oversight authorities, and 5) identification of who will submit records and/or reports. (SS)

4.2.3.2.6

Incorporation of quality system essentials required by these CT Standards.

Guidance

The committee created new standard 4.2.3.2.6 to ensure that all parties covered by the agreement(s) incorporate the core elements of the QSEs that are included in this edition. (SC)

☑ Actionable Checklist

• Develop a comprehensive agreement template that includes sections for defining roles and responsibilities of key personnel.
  • Include a list of key personnel with decision-making authority and their contact information.
• Clearly outline roles and responsibilities for each party in procurement, processing, labeling, storage, distribution, and administration of cellular therapy products.
  • Ensure documentation of chain of identity and chain of custody procedures.
• Establish a communication protocol for critical information, including deviations, nonconformances, adverse events, and changes in facility status.
  • Reference SOPs for handling deviations and nonconformances.
• Define procedures for reporting adverse events and nonconformances to regulatory bodies, Competent Authorities, and registries.
  • Maintain a log of all reported events and their outcomes.
• Specify requirements for donor and patient care, quality, safety, and other critical parameters in agreements.
  • Include product collection parameters and manufacturing requirements.
• Ensure agreements incorporate quality system essentials as required by the CT Standards.
  • Conduct a review of agreements to verify compliance with QSEs.

4.2.4 Changes to Agreements

[Cord blood applicable]

The parties shall define how changes to agreements are proposed, accepted, and communicated to affected parties.

☑ Actionable Checklist

• Define a procedure for proposing changes to agreements, including required documentation.
  • Reference SOP: SOP-AGM-001 “Agreement Change Proposal Process”
• Establish a process for reviewing and accepting proposed changes to agreements.
  • Reference SOP: SOP-AGM-002 “Agreement Change Review and Approval”
• Develop a communication plan for notifying affected parties of changes to agreements.
  • Reference SOP: SOP-AGM-003 “Agreement Change Communication”
• Maintain a log of all proposed and accepted changes to agreements.
  • Use Form: FORM-AGM-LOG “Agreement Change Log”
• Conduct training for relevant staff on the process for handling changes to agreements.
  • Document training in Training Records: TR-AGM-001
• Review and update the agreement change process annually or as needed during management reviews.

4.2.5 Agreements Relating to Cellular Therapy Products, Materials, and Services

[Cord blood applicable]

When the responsibilities for activities covered by these CT Standards involve more than one party or department, there shall be agreements that define the following for the cellular therapy product from point of origin to administration, including, but not limited to the following:

☑ Actionable Checklist

• Develop and maintain agreements with all parties involved in cellular therapy product handling.
  • Ensure agreements clearly define roles and responsibilities from point of origin to administration.
  • Include specific terms for product handling, storage, and transportation.
• Review and update agreements annually or as changes occur.
• Document all agreements and store them in a centralized, accessible location.
• Conduct regular audits to ensure compliance with agreement terms.
• Train staff on the content and importance of these agreements.
• Maintain a log of all agreements, including dates of execution and review.

4.2.5.1 Medical Authorization for Procurement and Processing

[F]

The facility shall have medical authorization for procurement and processing of cellular therapy products, except where the recipient is unknown and the procurement of the product is noninvasive. The facility shall ensure that agreements define the following:

1. Responsibility of the procuring facility to obtain a medical order before the procurement procedure.
2. Responsibility of the processing facility to obtain a medical order before the processing procedure, if applicable.
3. Responsibility of the clinical facility to provide the medical order for procurement or processing.

Standards 5.12.1 and 5.15.1 apply.

Guidance

Items 1 and 2 place responsibility on the procurement and/or processing facility to ensure that their agreements detail how they will obtain the medical order to procure and/or process before these events take place. Item 3 places responsibility on the clinical facility to ensure that its agreements detail how it will provide the medical orders to the procurement/processing facility(ies) before procurement/processing. (SS)

☑ Actionable Checklist

• Develop and maintain SOPs for obtaining medical authorization prior to procurement and processing.
  • Include procedures for verifying medical orders before procurement.
  • Include procedures for verifying medical orders before processing.
• Establish agreements with procuring and processing facilities detailing responsibilities for obtaining medical orders.
  • Ensure agreements specify the responsibility of the procuring facility for obtaining medical orders.
  • Ensure agreements specify the responsibility of the processing facility for obtaining medical orders.
• Establish agreements with clinical facilities detailing responsibilities for providing medical orders.
  • Ensure agreements specify the responsibility of the clinical facility to provide medical orders.
• Conduct regular audits to verify compliance with medical authorization procedures.
• Maintain a log of all medical orders received for procurement and processing.
• Review and update agreements annually or as needed to ensure compliance with standards.

4.2.5.2 Medical Authorization for Distribution

The facility shall ensure that agreements define the following:

1. Responsibility for the distributing facility to obtain a medical order before distribution.
2. Responsibility for the receiving facility to provide a medical order for distribution.

Guidance

The agreement and the responsibilities of both the distribution and receiving facilities. It would include, at a minimum, the name of the facility distributing the product, the facility requesting/receiving the product (if different), and product information (eg, type, requested dose, identifier). It may also include recipient information and donor eligibility. (SS)

☑ Actionable Checklist

• Review and update agreements with distributing facilities to ensure they include the responsibility to obtain a medical order before distribution.
  • Verify that agreements specify the name of the distributing facility, product type, requested dose, and identifier.
• Ensure agreements with receiving facilities clearly define their responsibility to provide a medical order for distribution.
  • Include facility name, product details, and recipient information in the agreements.
• Conduct a gap analysis to confirm all agreements meet AABB CT Standard 4.2.5.2 requirements.
• Develop or update SOPs related to obtaining and providing medical orders for distribution.
• Implement a tracking log to document and verify the receipt and provision of medical orders.
• Schedule regular reviews of agreements and SOPs to ensure ongoing compliance with standard requirements.

4.3 Incoming Receipt, Inspection, and Testing

[Cord blood applicable]

Incoming products, equipment, and materials shall be received, inspected, and tested, as necessary, before approval for use. Standard 3.2 applies.

Guidance

The committee added standard 4.3 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for the receipt, inspection, and testing of incoming products, equipment, and materials.
  • Include criteria for acceptance and rejection in the SOP.
  • Reference Standard 3.2 for additional requirements.
• Train staff on the SOP for incoming receipt, inspection, and testing.
  • Document all training sessions and maintain records.
• Create a log for documenting the receipt and inspection results of incoming items.
  • Ensure the log includes date, item description, inspection results, and disposition.
• Establish a testing protocol for incoming materials that require testing before use.
  • Maintain records of all test results and actions taken based on those results.
• Conduct regular internal audits to ensure compliance with the SOP and AABB standards.
  • Document findings and implement corrective actions as necessary.

4.3.1 Transfer of Products

[F]

When products are transferred between departments or facilities, the following items shall be defined:

1. Responsibility for maintaining the chain of identity during transfer.
2. Responsibility for maintaining the chain of custody during transfer.
3. Timing of product delivery and administration.
4. Agreement by all parties to provide the necessary documentation, including timing of the following, as applicable:
   a) Mobilization.
   b) Procurement.
   c) Recipient conditioning.

Guidance

Facilities that routinely transfer CT products between department or facility locations within the same
organization may not have formal written agreements. However, the requirements of Standard 4.3.2
should be addressed in the organization’s local policies, processes, and procedures or memoranda of understanding specific to the CT product chain of custody and timing of delivery. (SS)

☑ Actionable Checklist

• Define and document the responsibility for maintaining the chain of identity during product transfer in SOP CT-001.
  • Ensure all staff involved are trained on SOP CT-001 and maintain training records.
• Define and document the responsibility for maintaining the chain of custody during product transfer in SOP CT-002.
  • Conduct competency evaluations for staff on SOP CT-002 and file results.
• Establish and document the timing of product delivery and administration in SOP CT-003.
  • Create a log to track delivery and administration times and review monthly.
• Develop an agreement template for all parties to ensure necessary documentation is provided, including timing of mobilization, procurement, and recipient conditioning.
  • Review and update the agreement template annually or as needed.
• Conduct regular internal audits to verify compliance with transfer procedures and document findings.
• Implement a CAPA process for any deviations identified during product transfer and document all actions taken.

4.3.2 Instructions

[F]

When products are transferred between departments or facilities, instructions shall be provided for the following:

1. Collection, transport, receipt, handling, and administration of the cellular therapy product(s).
2. Reporting postinfusion outcomes data and adverse events to the issuing facility and other parties.

☑ Actionable Checklist

• Develop and maintain SOPs for the collection, transport, receipt, handling, and administration of cellular therapy products.
  • Ensure SOPs include detailed instructions for each step of the process.
• Create a standardized form for documenting the transfer of cellular therapy products between departments or facilities.
• Implement a tracking log for all cellular therapy product transfers, ensuring traceability.
• Establish a procedure for reporting postinfusion outcomes data and adverse events.
  • Include a clear timeline and responsible parties for reporting.
• Conduct training sessions for staff on the SOPs related to product transfer and reporting.
  • Document attendance and competency evaluations for all training sessions.
• Perform regular audits to ensure compliance with SOPs and reporting procedures.

4.3.3 Records

[Cord blood applicable]

When products are transferred between facilities, the following items shall be defined:

1. Responsibility of the administering facility or registry for the creation and retention of records of outcomes data listed in Standards 5.2, 5.2.1, 5.2.2, 5.2.2.1, 5.2.3, 5.2.4 and 5.2.4.1.
2. Responsibilities of each facility involved to provide records of the procurement, processing, labeling, storage, distribution, or administration of a cellular therapy product.
3. Time frames for making records available for review or transfer upon request.

Guidance

The intent of this standard is to define, within the agreement, the time frame(s) for making records available. This should be consistent with the concept of “readily available.” This could be met by defining what are mutually acceptable time frames for producing records in relation to their value of compliance with these CT Standards. As an example, the parties may agree that manufacturing records will be created within 24 hours, whereas vendor qualifications will be created within 1 week. In both instances, the time frames are defined and agreed upon by all involved parties. (SS)

☑ Actionable Checklist

• Define and document the responsibility of the administering facility or registry for creating and retaining outcomes data records as per Standards 5.2, 5.2.1, 5.2.2, 5.2.2.1, 5.2.3, 5.2.4, and 5.2.4.1.
  • Reference SOP for outcomes data management and retention.
• Establish and document the responsibilities of each facility involved in providing records of procurement, processing, labeling, storage, distribution, or administration of cellular therapy products.
  • Reference SOPs for each process (procurement, processing, etc.).
• Define and document mutually acceptable time frames for making records available for review or transfer upon request.
  • Include time frames in inter-facility agreements or contracts.
• Implement a tracking system to ensure compliance with defined time frames for record availability.
  • Use a log or database to monitor record requests and fulfillment.
• Conduct regular audits to verify adherence to responsibilities and time frames for record management.
  • Document audit findings and corrective actions in quality records.
• Train staff on the defined responsibilities and time frames for record creation and availability.
  • Maintain training records and competency evaluations.

4.3.4 Conditions for Product Storage and Disposition

[Cord blood applicable]

When products are transferred between departments or facilities, the following conditions shall be defined:

1. Maintenance of the chain of identity.
2. Maintenance of the chain of custody.
3. Terms and lengths of storage.
4. Possible transfer to another facility.
5. Disposition of the cellular therapy product, including discard.

☑ Actionable Checklist

• Develop and implement an SOP for maintaining the chain of identity during product transfer.
  • Include procedures for labeling and documentation.
• Create a log to track the chain of custody for all product transfers.
  • Ensure all entries are complete and accurate.
• Define and document terms and lengths of storage in a storage policy.
  • Review and update the policy annually.
• Establish criteria and procedures for transferring products to another facility.
  • Include necessary agreements and documentation requirements.
• Develop an SOP for the disposition of cellular therapy products, including discard procedures.
  • Ensure compliance with regulatory and safety standards.

4.3.5 Information about Product Administration

When products are transferred between departments or facilities, the following items shall be
obtained:

1. Summary record of cellular therapy product administration.
2. Summary of adverse events suspected to be linked to the cellular therapy product. Standard 7.3 applies.

☑ Actionable Checklist

• Develop and implement an SOP for obtaining summary records of cellular therapy product administration when products are transferred.
  • Include a checklist of required information to be collected.
• Create a standardized form or electronic log to document the summary record of product administration.
• Establish a procedure for obtaining and documenting summaries of adverse events suspected to be linked to the cellular therapy product.
  • Reference Standard 7.3 in the procedure for adverse event documentation.
• Train relevant staff on the SOPs for obtaining and documenting product administration and adverse event summaries.
  • Maintain training records and competency evaluations.
• Conduct regular audits to ensure compliance with procedures for information transfer and documentation.
• Review and update the SOPs and forms annually or as needed based on audit findings or regulatory changes.

4.3.6 International Requests for Cellular Therapy Products

[F]

When products are shipped or transported, the following shall be obtained:

1. Before shipment or transport, verification by the shipping facility that its local and FDA or relevant Competent Authority requirements for cellular therapy product manufacture and export have been met.
2. Before shipment or transport, verification by the receiving facility or registry that its local and FDA or relevant Competent Authority requirements for intended use of the cellular therapy products are met.
3. Agreement by all parties to exchange/provide the necessary documentation to meet export/ import requirements.

Guidance

Any facility shipping products to another country is responsible for checking all local import/export regulations of the country receiving the product. For example, facilities outside the United States that procure, process, test, label, store, and distribute cellular therapy products that do not meet the regulations for biologic product donor screening and donor eligibility determination of the FDA may not import products to the United States without FDA authorization. (SS)

☑ Actionable Checklist

• Verify compliance with local and FDA or relevant Competent Authority requirements for cellular therapy product manufacture and export before shipment.
  • Review and update SOPs related to export compliance.
  • Maintain a checklist of regulatory requirements for each destination country.
• Confirm that the receiving facility or registry meets local and FDA or relevant Competent Authority requirements for intended use before shipment.
  • Obtain written confirmation from the receiving facility of compliance with local regulations.
  • Document verification process in the shipment log.
• Ensure agreement by all parties to exchange necessary documentation for export/import requirements.
  • Develop a standard agreement template for documentation exchange.
  • Record all exchanged documents in the shipment file.
• Conduct a pre-shipment review meeting to confirm all regulatory requirements are met.
  • Include representatives from quality, regulatory, and logistics teams.
  • Document meeting minutes and action items.
• Regularly update and review crosswalk documents mapping SOPs to international shipping standards.
• Train staff on international shipping regulations and documentation requirements.
  • Keep training records and competency evaluations current.

4.4 Educational and Promotional Materials

[F]

The facility shall maintain records justifying claims made in its educational and promotional materials.

Guidance

Examples of inappropriate educational and promotional materials would include unsubstantiated claims that promote the clinical application, benefits, or effectiveness of a CT product without any clinical or scientific evidence supporting the claims. (SS)

☑ Actionable Checklist

• Develop and maintain a log of all educational and promotional materials used by the facility.
  • Include a section in the log for documenting the justification of claims made in each material.
• Establish an SOP for the review and approval process of educational and promotional materials.
  • Ensure the SOP includes criteria for substantiating claims with clinical or scientific evidence.
• Conduct a quarterly review of all educational and promotional materials to ensure compliance with substantiation requirements.
  • Document the review process and any updates or changes made to materials.
• Train staff involved in creating educational and promotional materials on the requirements for substantiating claims.
  • Keep training records and competency evaluations current and accessible.
• Implement a CAPA process for addressing any identified non-compliance with substantiation requirements.
  • Document all deviations and corrective actions taken in response to non-compliance.

4.4.1

Therapeutic and scientific claims in educational and promotional materials shall comply with applicable regulations and be approved by the relevant medical director.

Guidance

An example of how to meet this standard might be to include a review of all promotional materials as part of the annual internal assessment process (see Standard 8.0).

Promotional materials include all hard-copy and electronic media that are advertisements or informational in nature, including websites and giveaway materials. (SS)

☑ Actionable Checklist

• Develop an SOP for the review and approval process of educational and promotional materials.
  • Include steps for compliance verification with applicable regulations.
  • Specify the roles and responsibilities of the medical director in the approval process.
• Create a log to document the review and approval of all promotional materials.
  • Record dates, reviewers, and approval status.
• Schedule an annual review of all promotional materials as part of the internal assessment process.
  • Ensure inclusion of both hard-copy and electronic media.
• Maintain a crosswalk document mapping promotional materials to applicable regulations and standards.
• Conduct training for staff involved in creating and reviewing promotional materials on regulatory compliance.
• Implement a CAPA process for addressing non-compliance issues identified during reviews.

4.4.2

Therapeutic and scientific claims shall not promote or advertise experimental cellular therapies for administration outside the context of an independent ethics-committee-approved protocol.

☑ Actionable Checklist

• Review all marketing materials to ensure no claims are made about experimental therapies outside approved protocols.
  • Cross-reference claims with ethics committee-approved protocols.
• Implement an SOP for the review and approval of all promotional content.
• Train marketing and sales staff on compliance with ethical and regulatory standards.
• Conduct quarterly audits of promotional materials to verify compliance.
• Document any deviations found during audits and initiate CAPAs as needed.
• Maintain a log of all ethics committee-approved protocols and associated claims.

4.5 Donor Informed Consent

[F]

Informed consent of donors shall be obtained in conformance with Reference Standard 4.5A, Donor Informed Consent or Authorization.*

Guidance

Autologous donors would need to consent to both aspects of product collection and administration. Both of these elements can be represented in the same physical document, or the facilities can have two separate documents. In some facilities, two separate documents will be necessary because different departments are responsible for the collection vs administration, so they may want separate informed consents. (SS)

☑ Actionable Checklist

• Develop and maintain an SOP for obtaining donor informed consent, referencing Reference Standard 4.5A.
  • Ensure SOP includes procedures for both autologous and allogeneic donors.
• Create and update informed consent forms for product collection and administration.
  • Ensure forms are compliant with legal and ethical standards.
• Train staff on the informed consent process and document completion.
  • Maintain training records and competency evaluations.
• Conduct regular audits of informed consent documentation for compliance and completeness.
• Implement a system for documenting and addressing any deviations or issues in the informed consent process.
• Review and update informed consent processes and documents annually or as regulations change.

4.5.1

Donor informed consent templates shall be reviewed at defined intervals and updated as needed and approved by the current medical director of the facility responsible for obtaining informed consent.

Guidance

The informed consent process for donors (or those authorized to consent for the donor) should include an explanation, in understandable terms to the consenter(s), of any applicable risks, discomforts, benefits, and alternatives. (SS)

☑ Actionable Checklist

• Review donor informed consent templates at defined intervals (e.g., annually).
  • Document the review date and findings in the consent template review log.
• Update donor informed consent templates as needed based on review findings.
  • Ensure updates include any changes in risks, discomforts, benefits, and alternatives.
• Obtain approval for updated donor informed consent templates from the current medical director.
  • Document the medical director’s approval in the consent template approval log.
• Maintain a record of all versions of donor informed consent templates.
  • Archive previous versions with review and approval documentation.
• Ensure all staff involved in obtaining informed consent are trained on the current template.
  • Document training completion in staff training records.

4.5.2

Informed consent from the donor or a legally authorized representative shall be obtained (or initiated, for cord blood or gestational materials) before the procurement of cells, tissues, or organs from the donor.

☑ Actionable Checklist

• Develop and maintain an SOP for obtaining informed consent from donors or legally authorized representatives.
  • Include detailed steps for the consent process, ensuring clarity and comprehension.
• Train staff on the informed consent process and document completion of training.
• Use a standardized informed consent form that includes all necessary information and complies with regulatory requirements.
• Maintain a log of all informed consent forms, ensuring they are signed and dated before procurement.
• Conduct regular audits of informed consent records to ensure compliance and identify any discrepancies.
• Implement a process for reviewing and updating informed consent forms and SOPs as regulations or standards change.

4.5.2.1

There shall be a process to identify vulnerable donor populations that require a donor advocate to address informed consent issues.

☑ Actionable Checklist

• Develop and implement an SOP for identifying vulnerable donor populations.
  • Include criteria for vulnerability assessment in the SOP.
• Establish a process for assigning a donor advocate to vulnerable donors.
  • Document the roles and responsibilities of the donor advocate.
• Train staff on the identification of vulnerable donors and the role of the donor advocate.
  • Maintain training records and competency evaluations.
• Create a form or checklist to document the assignment of a donor advocate.
• Conduct regular audits to ensure compliance with the process for identifying and supporting vulnerable donors.
• Review and update the process annually or as needed, documenting any changes in the management review records.

4.5.2.2

There shall be a process to provide a qualified interpreter when required and/or when applicable.

☑ Actionable Checklist

• Develop and implement an SOP for requesting and providing qualified interpreters.
  • Include criteria for when an interpreter is required.
  • List approved interpreter services and contact information.
• Maintain a log of interpreter requests and services provided.
• Train staff on the SOP for interpreter services and document training completion.
• Conduct annual reviews of interpreter service providers to ensure qualifications and availability.
• Include interpreter service evaluation in customer feedback surveys.
• Document any issues or deviations related to interpreter services and implement CAPAs as necessary.

4.5.3

The terms and length of storage, the possible transfer to another facility, and the disposition, including discard, of the cellular therapy product, shall be addressed with:

1. The donor (or other consenters, including the donor’s legally authorized representative or, in the case of cord blood or gestational materials, the birth mother, biologic mother, and, where applicable, surrogate mother).
2. If known, the intended recipient and the recipient’s physician.

☑ Actionable Checklist

• Develop and maintain an SOP for addressing terms and length of storage, transfer, and disposition of cellular therapy products.
  • Include procedures for obtaining consent from donors, legally authorized representatives, and applicable mothers.
  • Outline steps for communicating with intended recipients and their physicians.
• Create a consent form template that includes storage, transfer, and disposition terms for cellular therapy products.
• Implement a tracking system for documenting consent from all relevant parties.
• Conduct regular training sessions for staff on the SOP and consent process.
• Perform internal audits to ensure compliance with consent documentation and communication procedures.
• Review and update SOPs and consent forms annually or as needed based on regulatory changes.

4.6 Authorization for Cadaveric Donors

[F]

Authorization of donors shall be obtained in conformance with Reference Standard 4.5A, Donor Informed Consent or Authorization.

☑ Actionable Checklist

• Review and update SOPs to ensure compliance with Reference Standard 4.5A for donor informed consent or authorization.
  • Include specific procedures for obtaining authorization for cadaveric donors.
• Maintain a log of all cadaveric donor authorizations, including date, time, and personnel involved.
• Conduct regular audits of donor authorization records to ensure compliance with SOPs.
• Train staff on the updated procedures for obtaining cadaveric donor authorization.
  • Document all training sessions and maintain records in the training log.
• Implement a CAPA process for any deviations identified during audits related to donor authorization.
• Schedule periodic management reviews to assess compliance with donor authorization requirements.

4.6.1

Any authorization templates shall be reviewed at defined intervals and updated as needed and
approved by the current medical director of the facility responsible for obtaining authorization.

☑ Actionable Checklist

• Review authorization templates at defined intervals as per SOP.
  • Document the review date and findings in the authorization template review log.
• Update authorization templates as needed based on review findings.
  • Ensure updates are approved by the current medical director.
• Maintain a record of all authorization template versions and approvals.
• Conduct training for relevant staff on updated authorization templates.
• Include authorization template review in the internal audit schedule.

4.6.2

The legal record of authorization shall be obtained before the procurement of cells, tissues, or organs from the donor.

Guidance

The “legal record of authorization” relates to two terms in the glossary and their definitions:

Record: Information captured in writing or through electronically generated media that provides objective evidence of activities that have been performed or results that have been achieved, such as test records or audit results. Records do not exist until the activity has been performed and documented.

Authorization (in relation to procurement from cadaveric donors): A legal record providing permission for postmortem recovery of cells/tissues and subsequent use.

For example, in the United States, documentation that can serve as a legal record of authorization is governed by individual state law and modeled after the (revised) Uniform Anatomical Gift Act template. This legal record can originate in two ways:

1. From the donor. Before death, individuals can execute their right to donate their body or parts of their body (such as cells, tissues, and/or organs) by creating a document of their gift that meets applicable laws and regulations. Acceptable documentation may include a state driver’s license, living will, advance directive, state identification card, donor card, or photocopy thereof, and/or documentation that the donor registered in a formal, legal donor registry.
2. From a legally authorized representative. Alternatively, for those donors who did not express, before death, their wish to donate, permission must be obtained from a person legally authorized to act on behalf of the donor. This must occur in accordance with the applicable state’s anatomical gift act and other laws or regulations. Such authorization must be expressed on a legal record of the gift of tissue, permitting and defining the scope of the postmortem recovery and use of tissues. Pursuant to law, the record must be signed or otherwise recorded by the authorizing person. (SS)

☑ Actionable Checklist

• Develop and maintain an SOP for obtaining and verifying the legal record of authorization prior to procurement.
  • Include procedures for verifying donor documentation such as driver’s licenses, living wills, or donor cards.
  • Outline steps for obtaining authorization from a legally authorized representative if the donor did not pre-authorize.
• Train staff on the SOP for obtaining legal records of authorization and document all training sessions.
• Create a checklist or form to document the verification of legal authorization records for each donor.
• Conduct regular audits to ensure compliance with the SOP and legal requirements for authorization.
• Maintain a log of all legal records of authorization obtained, including copies of documentation and verification details.
• Review and update the SOP annually or as needed to reflect changes in laws or regulations regarding donor authorization.

4.6.3

The terms and length of storage, the possible transfer to another facility, and the disposition, including discard, of the cellular therapy product shall be addressed with:

1. The donor’s legally authorized representative.
2. If known, the intended recipient and the recipient’s physician.

☑ Actionable Checklist

• Develop and implement an SOP for addressing storage terms, transfer, and disposition of cellular therapy products.
  • Include procedures for communication with the donor’s legally authorized representative.
  • Include procedures for communication with the intended recipient and recipient’s physician, if known.
• Create a standard form or template for documenting agreements on storage, transfer, and disposition.
• Maintain a log of all communications and agreements related to storage, transfer, and disposition.
• Conduct training sessions for staff on the SOP and documentation requirements.
• Perform regular audits to ensure compliance with the SOP and documentation accuracy.
• Review and update the SOP annually or as needed based on audit findings or regulatory changes.

4.7 Patient Informed Consent

[F]

Informed consent for patients receiving cellular therapy treatment and administration of products shall be obtained in conformance with Reference Standard 4.7A, Patient Informed Consent.

Guidance

Autologous donors would need to consent to both aspects of product collection and administration.
Both of these elements can be represented in the same physical document, or the facilities can have two separate documents. Some facilities use two separate documents because different departments are responsible for the collection versus administration, so they may want separate informed consents. (SS)

☑ Actionable Checklist

• Develop and maintain a comprehensive SOP for obtaining informed consent for cellular therapy treatments.
  • Include procedures for both product collection and administration.
• Ensure informed consent documents comply with Reference Standard 4.7A.
• Train staff on the informed consent process and document completion.
  • Maintain training records and competency evaluations.
• Conduct regular audits of informed consent documentation for compliance.
• Implement a process for updating consent forms when regulatory or procedural changes occur.
• Document and review any deviations or CAPAs related to informed consent processes.

4.7.1

Patient informed consent templates shall be reviewed at defined intervals and updated as
needed and approved by the current medical director of the facility responsible for obtaining informed consent.

Guidance

The informed consent process for patients (ie, recipients) should include an explanation, in terms understandable to the consenter(s), of any applicable risks, discomforts, benefits, and alternatives. (SS)

☑ Actionable Checklist

• Establish a schedule for regular review of patient informed consent templates.
  • Document the review schedule in a relevant SOP.
• Assign responsibility for the review to a designated staff member or committee.
• Ensure the current medical director reviews and approves all updates to informed consent templates.
  • Maintain a log of approvals with dates and signatures.
• Verify that templates include understandable explanations of risks, discomforts, benefits, and alternatives.
  • Conduct a readability assessment of the templates.
• Implement a process to update templates as needed based on regulatory changes or feedback.
  • Document changes and rationale in a change control log.
• Train staff involved in obtaining informed consent on the updated templates.
  • Record training completion in training records.

4.7.2

The informed consent process for administration of products under research protocols shall be approved by an independent ethics committee.

☑ Actionable Checklist

• Ensure an SOP is in place for obtaining informed consent under research protocols.
  • Reference the SOP number and title in the consent process documentation.
• Verify that all research protocols involving product administration have ethics committee approval.
  • Maintain records of ethics committee approvals for each protocol.
• Document the informed consent process for each patient in the patient record.
  • Use a standardized consent form approved by the ethics committee.
• Conduct regular audits of informed consent documentation to ensure compliance.
• Train staff involved in the consent process on ethical and regulatory requirements.
  • Keep training records and competency evaluations up-to-date.
• Review and update the informed consent SOP annually or as regulations change.

4.7.3

Informed consent from the patient shall be obtained before the start of any preparative therapy.

☑ Actionable Checklist

• Develop and implement an SOP for obtaining informed consent prior to preparative therapy.
  • Include a process for verifying patient understanding and voluntary agreement.
• Maintain a log of all informed consent forms, ensuring each is signed and dated by the patient.
• Train staff on the informed consent process, documenting completion and competency evaluations.
• Conduct regular audits to ensure compliance with the informed consent SOP.
• Review and update informed consent forms annually or as regulations change.
• Document any deviations from the informed consent process and implement CAPAs as necessary.

4.8 Obtaining Materials, Services, and Cellular Therapy Products

The facility shall ensure that purchased, donated, or otherwise acquired materials, services, or cellular therapy products conform to specified requirements.

☑ Actionable Checklist

• Develop and maintain an SOP for the evaluation and selection of suppliers.
  • Include criteria for supplier qualification and re-evaluation.
• Establish a supplier approval list and update it regularly.
• Implement a process for verifying that received materials and products meet specified requirements.
  • Use a standardized form or checklist for material inspection and acceptance.
• Conduct regular audits of suppliers to ensure compliance with specified requirements.
• Document and review any deviations or non-conformances related to acquired materials or services.
• Maintain records of supplier performance evaluations and corrective actions taken.

4.8.1 Evaluation and Qualification of Suppliers of Materials and Services

[F]

The facility shall ensure that suppliers of critical materials or services are qualified and selected based on the supplier’s ability to meet specified requirements, including ensuring the following:

1. Training and qualifications of personnel who perform activities related to the provision of materials and/or services are addressed.
2. Facilities providing tests or manufacturing services required by these CT Standards are accredited by AABB or other relevant standardsetting organizations.
3. The supplier is appropriately qualified or authorized to provide such service as required by the relevant Competent Authority.

Guidance

When a vendor provides specific materials or services to a facility, the facility shall ensure that the agreement provides specific details in regard to vendor employee training and qualifications. It is not necessary for the facility to verify that the vendor meets these requirements, as they are already stipulated in the signed agreement between the two parties; however, it is important that the facility ensure that the vendor clearly understands the required training and qualifications for employees. (SS)

#2 - The committee updated subnumber 2 to mirror similar language found in other AABB Standards surrounding the requirement to be accredited by AABB or a similar accrediting body. (SC)

#3 - The committee created new Subnumber to the edition for completeness and was included to ensure that accredited facilities are working with suppliers who have been approved to provide those services by the appropriate Competent Authority. (SC)

☑ Actionable Checklist

• Develop and maintain a Supplier Qualification SOP that outlines the criteria for evaluating and selecting suppliers of critical materials and services.
  • Include requirements for supplier personnel training and qualifications in the SOP.
• Maintain a list of approved suppliers, ensuring they meet specified requirements, including accreditation by AABB or other relevant organizations.
• Verify and document the accreditation status of suppliers providing tests or manufacturing services.
• Ensure supplier agreements specify the training and qualifications required for vendor employees.
• Conduct and document periodic reviews of supplier performance and compliance with agreements.
• Verify that suppliers are qualified or authorized by the relevant Competent Authority to provide the required services.

4.8.1.1

The facility shall review package inserts for all infectious disease test reagents and kits, including their sample requirements, to verify they are approved for their intended use in testing of cellular therapy products. Standards 5.10.2.6 and 5.10.2.10 apply.

☑ Actionable Checklist

• Review and document package inserts for all infectious disease test reagents and kits used.
  • Verify each reagent and kit is approved for its intended use in cellular therapy product testing.
  • Ensure sample requirements align with testing protocols.
• Update SOPs to include procedures for reviewing and verifying package inserts.
• Maintain a log of all reviewed package inserts, including approval status and sample requirements.
• Conduct training sessions for staff on the importance of verifying package inserts and document attendance.
• Schedule regular audits to ensure compliance with package insert review procedures.
• Implement a CAPA process for any discrepancies found during the review of package inserts.

4.8.2 Evaluation and Qualification of Suppliers of Cellular Therapy Products

[F]

The facility shall ensure that suppliers of cellular therapy products are qualified and selected based on the following requirements:

1. The source facility is authorized, designated, licensed, registered, and/or accredited.
2. Specified product procurement requirements are met when these activities are performed by a supplier.
3. Training and qualifications of personnel who perform activities related to the supply of cellular therapy products are addressed.
4. Facilities providing cellular therapy products are accredited by AABB or another accrediting body.

Guidance

If a facility is using an unrelated-donor registry such as NMDP to coordinate the collection, testing, transport, etc of cellular therapy products, the accredited facility does not need to perform this evaluation and qualification of the provider facility again, because NMDP performs a comprehensive review of CT service providers used by the organization.

However, the entity that has the responsibility to perform this review and ensure that they meet specified requirements should be highlighted in agreements. A facility cannot use the supplier’s accreditation status from AABB and/or another accrediting body as the only qualification criterion; it must also meet the other requirements in the standard. (SS)

☑ Actionable Checklist

• Verify that all suppliers of cellular therapy products are authorized, designated, licensed, registered, and/or accredited.
  • Maintain a log of supplier accreditations and licenses.
• Ensure procurement requirements are documented and met by suppliers.
  • Review and update procurement SOPs to include supplier requirements.
• Confirm training and qualifications of supplier personnel involved in cellular therapy product supply.
  • Request and review supplier training records and competency evaluations.
• Verify that facilities providing cellular therapy products are accredited by AABB or another recognized accrediting body.
  • Keep copies of current accreditation certificates on file.
• Include evaluation and qualification criteria in supplier agreements.
  • Review and update supplier agreements to specify responsibilities for meeting requirements.
• Document and review the evaluation process for each supplier annually.
  • Conduct and document an annual supplier audit to ensure compliance with standards.

4.8.3 Monitoring of Suppliers of Materials, Services, and Cellular Therapy Products

The facility shall:

1. Monitor the performance of critical suppliers as needed based on the nature of the material, service, or product and the impact on the quality of the cellular therapy product.
2. Take corrective action and report to management when a supplier fails to meet specified requirements. Standard 9.1 applies.

Guidance

Suppliers must be qualified before use to demonstrate that they can consistently meet the facility’s requirements. The standard does not define which suppliers are deemed critical; the facility should evaluate its operations and make this determination. For example, the facility may choose not to qualify and monitor a supplier of office stationery materials because these are not critical materials.

A list of qualified suppliers should be provided to personnel who make purchasing requisitions. Further, the facility should have a policy restricting the purchase of critical materials and services to purchase from qualified providers. The facility should determine the type and extent of control that it expects to exercise over the supplier and identify what criteria will be used for evaluating supplier acceptability. (SS)

☑ Actionable Checklist

• Develop and maintain a list of qualified critical suppliers for materials, services, and cellular therapy products.
  • Include criteria for determining supplier criticality in the SOP.
• Implement a procedure for monitoring the performance of critical suppliers.
  • Define metrics and frequency for supplier performance evaluation.
• Document all supplier evaluations and maintain records in a supplier performance log.
• Establish a process for taking corrective action when a supplier fails to meet requirements.
  • Include a reporting mechanism to management for supplier issues.
• Conduct regular reviews of supplier performance and update the qualified supplier list as needed.
• Train relevant personnel on the policy restricting purchases to qualified suppliers and ensure compliance.

4.8.4 Notification

[Cord blood applicable]

The agreement between the receiving facility and the supplier shall include a process to notify the shipping facility and the manufacturer (if applicable) when materials are received in an unacceptable condition. Chapter 7, Deviations, Nonconformances, and Adverse Events, applies.

Guidance

It is important to track deviations, rejections, and complaints because all of these factors reflect a supplier’s performance. Quality problems should be recorded and brought to the attention of management with contracting authority and to the suppliers. It is required that corrective action plans be developed to address problems. It is important to remember that supplier qualification does not eliminate the need to validate a particular critical material or service for use in the program’s processes and procedures. (SS)

Reference Standard 4.5A — Donor Informed Consent or Authorization

Reference Standard 4.7A — Patient Informed Consent

Excerpt of Reference Standard 6.2.9A Relevant to Suppliers and Customers

Standard	Record to Be Maintained	Quality System Records	Donor Eligibility/ Management Issues	Unit/ Recipient	Retention after Creation (C) or Final Disposition (F) of Related Product	Minimum Retention Time (in years)1
4.1	Evaluation and participation in selection of suppliers	X	X	X	C	10
4.2	Agreements	X	X	X	C	10
4.2.1	Agreement review	X	X	X	C	10
4.2.3	Agreements concerning activities involving more than one organization	X	X	X	C	10
4.2.4	Agreement changes communicated to affected parties	X	X	X	C	10
4.2.5	Review of agreements before acceptance and at facilitydefined intervals	X	X	X	C	10
4.2.5.1	Agreements for the timing and responsibility of medical orders	X	X	X	F	10
4.3	Inspection of incoming critical materials	X	X	X	C	10
4.3.1	Agreements between departments or facilities regarding the transfer of products	X	X	X	F	10
4.3.2	Agreements for the collection, transport, receipt, handling, and administration of the cellular therapy product, reporting adverse events, and obtaining outcome data	X	X	X	F	10
4.3.3	Agreement between processing/ issuing facility and the administering facility or registry for creation and retention of records; agreements for each facility to access relevant records	X	X	X	C	10
4.3.4	Conditions for product storage and disposition	X	X	X	C	10
4.3.6	Shipment of cellular therapy products	N/A	N/A	X	F	10
4.4	Claims in educational and promotional materials	X	X	X	F	10
4.5	Donor informed consent	X	X	X	F	10
4.6	Authorization for cadaveric donors	X	X	X	F	10
4.7	Patient informed consent	X	X	X	F	10
4.8.1, 4.8.2	Evaluation, qualification, and selection of suppliers of materials, services, and products	X	X	X	F	10
4.8.3	Monitoring of suppliers (including reporting to management of a supplier’s failures to meet specified requirements)	X	X	X	F	10
4.8.4	Notification of shipping facility and manufacturer (if applicable) when materials are received in an unacceptable condition	X	X	X	C	10

¹Applicable federal, state, or local law may exceed this period.

☑ Actionable Checklist

• Develop and implement an SOP for notifying the shipping facility and manufacturer when materials are received in unacceptable condition.
  • Include criteria for unacceptable conditions in the SOP.
  • Define roles and responsibilities for notification within the SOP.
• Ensure all agreements with suppliers include a notification process for unacceptable materials.
  • Review current agreements to verify inclusion of notification clauses.
  • Update agreements as necessary to comply with the standard.
• Maintain a log of all notifications sent to suppliers regarding unacceptable materials.
  • Include date, time, and details of the condition in the log.
• Conduct training sessions for relevant staff on the notification process for unacceptable materials.
  • Document attendance and completion of training in training records.
• Perform regular audits of the notification process to ensure compliance with the SOP and agreements.
  • Document findings and corrective actions from audits.
• Implement a CAPA process for addressing issues related to unacceptable materials received from suppliers.
  • Track all CAPAs in a dedicated log and review them during management reviews.