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). (For more on The Heightened Importance of Contract Manufacturing Organizations, read this post.)
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
- 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
A Quality Agreement With Suppliers Is Necessary, But Not Sufficient
While a well-written vendor quality agreement can provide some much-needed protections for the Sponsor, it is not enough to satisfactorily reduce compliance risk. Leading Sponsors use data to monitor the Inspections and Enforcement Actions of their suppliers. If one of their suppliers gets inspected by one of the major agencies, like FDA, EMA, or Health Canada, they need to know the results of that inspection.
Even if the supplier is supposed to share those inspection results as outlined by the quality agreement, the Sponsor should be able to independently access that data in an automated way.
That’s where Redica Systems can help. You can set up customized, automated alerts, based on a list of suppliers that you specify.
Redica Resources for Vendor Quality
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.
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