What is a GMP Quality Agreement?

If you outsource GMP operations, a quality agreement is a critical document. The 2016 FDA guidance defines a quality agreement as 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.”

Further, a quality agreement should state which party carries out specific cGMP activities. Keep in mind that a firm is ultimately still responsible for ensuring GMPs are followed during manufacturing of a product, even if that product is manufactured off-site by a contract manufacturing organization (CMO).

GMP Quality Agreement Basics

In an article written last year, Jerry Chapman covered remarks Alan Minsk, Partner and Leader of the Food and Drug Practice team at the law firm Arnall Golden Gregory delivered at the 2021 International GMP Conference. Minsk identified the following goals of a quality agreement:

Ensure the quality, safety, and effectiveness of products
Minimize potential problems, confusion, errors, and regulatory deficiencies
Ensure all parties are on the same page
Reduce confusion between the two parties
Define expectations

FDA recommends the quality agreement should include:

A purpose or scope
Definitions
How conflicts involving product quality issues will be resolved
Processes for documenting manufacturing activities
Processes for preventing cross-contamination at sites manufacturing multiple products
Procedures for reporting manufacturing deviations and their associated investigations

At the 2021 PDA/FDA Joint Regulatory Conference, Genentech/Roche Executive Director and Global Head of External Development Collaborations Emma Ramnarine recommended taking a risk-based approach to relationships with CMOs and suppliers. This means addressing responsibilities when it comes to the quality system, including identifying acceptable levels of risk.

This “QRM mindset” approach is valuable for ensuring that a CMO partner conducts deviation investigations to the satisfaction of the firm.

How to Draft a Quality Agreement

When it comes to developing a quality agreement, Minsk recommends the following:

Account for oversight and application holder involvement
Minimize inconsistencies and conflicts
Be mindful of privacy considerations
Define roles and responsibilities
Use FDA-defined terms whenever possible
Ensure mutual understanding between both parties

Redica Resources for Vendor Quality

Vendor Monitoring at the Push of a Button

Quality Agreements: Part I, Why They are Critical

Quality Agreements: Part II, How to Write Good Ones

Ensure Adequate Investigations at Your CMO With a QRM Mindset

Are you in the process of selecting a new CMO? Did you know Redica allows you to quickly compare the enforcement histories for selected sites using a set of filters? Below is a comparison of enforcement activity over a ten-year period for a sample of U.S. sites for three major CMOs. Contact us to see how Redica can help with vendor quality.