Quality Agreements – PART 1

What Is a Quality Agreement?

  • A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with cGMP.
  • Quality agreements should not cover general business terms and conditions such as confidentiality, pricing or cost issues, delivery terms, or limits on liability or damages.

Elements of a Quality Agreement

  • A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under cGMP.
  • It will define key manufacturing roles and responsibilities.
  • It will establish expectations for communication, providing key contacts for both parties.
  • It will specify which products and/or services the owner expects from the contract facility and who has final approval for various activities.
  • Most quality agreements contain the following sections:

i. Purpose/Scope — to cover the nature of the contract manufacturing services to be provided

ii. Definitions — to ensure that the owner and contract facility agree on precise meaning of terms in the quality agreement

iii. Resolution of disagreements — to explain how the parties will resolve disagreements about product quality issues or other problems

iv. Manufacturing activities — to document quality unit and other activities associated with manufacturing processes as well as control of changes to manufacturing processes

v Life cycle of, and revisions to, the quality agreement

  • The owner may consider including the contract facility’s established processes and procedures as part of the quality agreement.
  • The quality agreement should explain how the contractor will report manufacturing deviations to the owner, as well as how deviations will be investigated, documented, and resolved in compliance with cGMP.
  • Quality agreements should state that manufacturing services provided by contract facilities (including laboratories) will comply with cGMP.
  • The most critical pieces are quality and change control, as described in the following sections.
  1. Change Control Associated With Manufacturing Activities
  • Either an owner or a contract facility may initiate changes to processes, equipment, test methods, specifications, and other contractual requirements.
  • Both parties should discuss changes and address them in the quality agreement.
  • There are some changes that owners should review and approve before they are implemented and other changes contractors may implement without notifying the owner.
  • How all changes are managed should be outlined in the agreement, including allocation of responsibilities for conducting validation activities as needed before implementing changes.
  • Additionally, both parties should be aware of those changes that need to be submitted to FDA in a supplement or annual report.
  • The owner and contract facility should carefully consider and agree on the types of changes to report to each other and to FDA and the need for approval from each party’s quality unit and FDA, as applicable.
  • The quality agreement should address expectations for reporting and approving changes to the following:

-Components and/or their suppliers

-Establishment locations

-Manufacturing processes

-Products or product types that use the same production line, equipment train, or facility

-Testing procedures

-Major manufacturing equipment

-Shipping methods

-Lot numbering scheme

-Container closure systems

-Tamper evidence features

-Product distribution

  • Various unexpected events, such as manufacturing deviations, complaints, product recalls, adverse event reports, master label changes, field alert reports, and biological product deviation reports, may necessitate changes to processes and procedures.
  • Process improvement projects, process capability analyses, and trending reports may also necessitate changes to processes and procedures.
  • The quality agreement should include the owner’s and contract facility’s expectations for reporting and communication in case of unexpected events and related changes

2. Manufacturing Activities

  • Quality agreements may document each party’s roles and manufacturing activities with a variety of formats, charts, matrices, narratives, or a combination of these.
  • Quality agreement should clearly document which party is responsible for specific activities.
  • No party to a quality agreement may delegate any of its responsibilities to comply with cGMP through the quality agreement or any other means.
  • The quality agreement should cover all of the activities for ensuring compliance with cGMP.
  • Quality agreement should indicate whether the owner or contract facility (or both) will handle specific activities related to each of the following topics, each of the topic shall be discussed in detail in next article.

-Quality Unit Activities

-Facilities and equipment

-Material management

-Product Specific Considerations

-Laboratory Controls


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