First Warning Letter Citation of new FDA Guideline on Contracts

Recommendation

7/8 May 2024

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End of last year, the US Food and Drug Administration (FDA) published its long awaited final Guidance on Contract Manufacturer Quality Agreements.

The authority recommends that quality agreements should contain the following sections at a minimum:

• purpose and scope of the agreement
• terms of the agreement, including its effective dates
• terms for dispute resolution
• responsibility of each respective party
• change control and revision practices

And it seems that the agency takes things seriously. In a recent Warning Letter from January 19, 2017, the FDA refers to Quality Agreements and the respective guidance: "Firms acting as contract manufacturers must comply with CGMP. FDA is aware that many pharmaceutical product manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. The FDA regards contractors as extensions of the manufacturer." In their relationship with a customer, they recommend the addressee (Porton Biopharma, a U.K. based company) to have a look at FDA's guidance document.

Interesting is the fact that the facility was inspected March 7 to 18, 2016 - about eight months before the final guidance was published.