FDA Guidance Helps Further Clarify Quality Agreements

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-12-07-2016, Volume 11, Issue 12

Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor

As more pharmaceutical companies are relying on contract manufacturing organization and contract development and manufacturing organization (CMO and CDMO) partners for manufacturing, clarifying roles and responsibilities has become more important than ever. FDA has released new guidance that spells out its views on how operating company sponsors and contract partners should interact within the broader framework of pharmaceutical quality systems.  The guidance covers best practices for written quality agreements, which are essential to establish a common understanding of each partner's roles and responsibilities.

As the guidance states, each party must meet current good manufacturing practices (cGMPs) and other requirements for manufacturing and quality activities.  However, responsibilities for oversight and controls over manufacturing rest squarely on the sponsors.  The sponsor’s (or “owner’s” in the guidance document) quality department is legally responsible for approving or rejecting products that were manufactured by their contract partners, including product made for final release, the document says.

FDA suggests that procedures and responsibilities be written down and strictly enforced.  The Quality Assurance department must describe materials, quality specs and communication mechanisms.  Owners should evaluate facilities, via audits, material testing and other means, to ensure that the company meets cGMP standards.

Written agreements define the manufacturing and quality responsibilities of each party, the guidance states, and should include considerations for subcontractors, as well as equipment, method and process changes.

Monitoring partners is especially important, as is monitoring incoming materials and encouraging quality risk management.


These documents should be considered independent of all other business documents, since they should not cover business or legal issues, but focus instead on quality and compliance. 

Ideally, each agreement should contain the following sections, FDA writes:

  • Purpose/scope

  • Definitions

  • Processes for conflict resolution

  • Manufacturing activity requirements and monitoring

  • Life cycle and QA requirements

The quality agreements should also delineate each party’s role in manufacturing, quality and facilities and equipment, i.e., which partner will validate processes and qualify equipment and systems (including Information Technology).  The document should also discuss how parties will communicate information on traceability and prevention of cross-contamination, in cases where one contract manufacturing organization manufactures several different products.

Component specifications, required sampling and testing, lab controls and change-control for manufacturing should all be clarified, and respective roles described in the agreement, the guidance says. The contract should set requirements for cGMPs that apply to all relevant operations within a contract partner’s facility, including analytical testing labs, the guidance says.