End 2016, the US Food and & 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 the agency takes things seriously. In a recent Warning Letter from March 2018, the FDA again refers to Quality Agreements and the respective guidance: "FDA is aware that many pharmaceutical product manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer." In their relationship with a customer, they recommend the addressee (Tris Pharma Inc.), to have a look at FDA's guidance document.
For further information please see the FDA Warning Letter to Tris Pharma Inc.