Quality Agreements – The Robust Cornerstone of Tissue Safety and Compliance

In the realm of tissue banking, where the stakes are measured in lives and the margin for error is minutely thin, the concept of a “quality agreement” stands as a shield and foundation. Quality agreements ensure that each party, whether a manufacturer, distributor, processor, or end-user, operates in unison and compliance with the highest standards for safety. So, what are quality agreements and why are they essential? Today we’ll explore the critical role of quality agreements, how they define the regulatory framework, and why they’re important in our industries!

What is a quality agreement?

A quality agreement is a legally binding comprehensive written (documented) contract between parties involved in manufacturing, testing, or distribution of a product. It defines each party’s roles, responsibilities, and expectations regarding safety, quality assurance and control, and ensuring all parties are compliant with applicable regulations and standards. This document establishes how partners will communicate, share information, and resolve disputes concerning quality and compliance. It covers details of all responsibilities across the operations such as acquisition/recovery, processing, labeling, storage, traceability, donor eligibility determination, distribution, reporting, auditing, and corrective actions in case of deviations or nonconformance. It also acts as an essential tool for demonstrating due diligence in partner selection, oversight, and management.

The Food and Drug Administration (FDA) provides the regulatory framework for human cells, tissues, and cellular and tissue-based products (HCT/Ps) through 21 CFR 1271 to prevent the transmission of communicable diseases and ensure the integrity of tissues distributed for transplantation or further manufacture. While 21 CFR 1271 does not directly spell out quality agreements, several bullet points make such agreements a regulatory expectation for establishments involved in recovery/acquisition, processing, storage, and distribution of HCT/Ps.

Points from 21 CFR 1271 [1] :

• requires establishments to ensure that all manufacturing steps (whether performed in-house or by contractors) are carried out in accordance with applicable requirements. This means any outsourced activity must be controlled, and compliance is the responsibility of the establishment.

• states that all establishments maintain a comprehensive quality program, including written procedures and records of quality activities. These procedures encompass training, facility maintenance, equipment, and critical operations that may involve more than one entity.

• covers the need for proper record-keeping and traceability, ensuring that tissues can be tracked from donor to recipient. This typically involves multiple organizations handling the same tissue product at different stages.

The only way to ensure that each part in the chain of custody or processing fulfills and complies with regulations (especially where the tasks are delegated or outsourced), is through a quality agreement. This agreement clarifies who is responsible for each aspect of compliance and provides a mechanism for oversight and accountability.

Benefits of Quality Agreements

Establishments that implement quality agreements have found:

• Communication improves as regularly communicating prevents misunderstandings and reduces the risk of errors.

• Assigning responsibilities and review mechanisms mitigates risks and helps identify potential compliance gaps before they become major issues.

• Safety is enhanced as clear procedures and shared expectations ensure tissues remain safe from contamination or mishandling at each step.

• During audits or inspections, documented agreements provide evidence of diligent oversight and compliance.

• Stronger business relationships fostering trust and long-term collaboration occur between the parties.

Effective Quality Agreements

An effective quality agreement for tissue banking should include the following core elements but not limited to:

• Definitions and scope

• Division of responsibilities

• Documentation and record maintenance

• Communication protocols

• Audit rights and procedures

• Personnel qualifications

• Corrective and preventive actions

• Change control

• Dates and signature acknowledgements by each party (if a standalone document)

What’s the risk if an establishment does not have a quality agreement? Great question! Establishments could be at risk for regulatory citations, impact to investigations and delayed reporting for product recalls or market withdrawals, and potential for harm to recipients of tissue transplants or therapies. Lack of control of outsourced activities can be mitigated by implementing quality agreements!

Overall, quality agreements are not mere formalities; they are the backbone of compliance, safety, and operational excellence in tissue banking. These agreements support partnerships, vigilance, and shared responsibility for the ultimate goal of providing safe, high-quality tissues for patients in need!

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Reference

[1] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271