Thursday, October 20, 2011

Alkemy 101 Newsletter - October 2011

Do you have a Quality Agreement with your Contract Manufacturer?
- What is a Quality Agreement, is it needed and how is it different than a Service Agreement?

- How are the raw materials in your finished product qualified by your manufacturer routinely?

- Should you get copies of test reports from your CMO partner for your finished products?

A Quality Agreement is a legally binding document, which outlines specific quality parameters for a service to be rendered and identifies the responsible party (or parties) obligated to uphold those parameters under the Service Agreement. In lamens terms, its the upfront contract you put in place with your manufacturer in addition to the Service Agreement, to make a product in accordance with your standards and current regulations. A Quality Agreement defines all the aspects of a service or product relating to how identity, purity/potency, quality and overall safety of a given product is manufactured and maintained. Whereas the Service Agreement typically defines the legalese and scope of a project as well as deliverables for a set price, it does not usually address "HOW" the partner will accomplish the service; hence, the Quality Agreement.

A well drafted Quality Agreement offers you protection should your contract manufacturer not uphold the terms therein. For example, if an agreed upon quality testing regimen is not followed or disregarded altogether, you may very well have legal leverage to change certain terms or dismiss the Service Agreement altogether. Same thing applies if your contract manufacturer is found operating not under cGMP compliance or changes raw material suppliers without your permission or appropriate qualifiction. Whether the CMO has an in-house laboratory or contracts with a third-party lab, you should request and have access to all testing records for your raw materials and your finished product on file.