Why Do You Need a Quality Agreement?

Why Do You Need a Quality Agreement?

April 11th, 2019 // 2:25 pm @

A quality agreement provides precise details of what is expected from both parties and who will be responsible for all of the aspects of the pharmaceutical project. There is a misconception that a quality agreement is only needed for CMOs operating in a different type of regulatory environment. This is not the case. Any outsourcing  contract arrangement should included a quality agreement, including an arrangement between different parts of the same company.

A formal policy document needs to clearly indicate the sorts of services and vendors that need a quality agreement. If a CMO or contractor is used, there must be a quality agreement. A quality agreement should be used with all vendors of vital materials. And it also is recommended for a vendor provided large quantities, such as methyl cellulose for drug capsules.

The quality agreement needs to be drafted and accepted by the contractor or CMO and client before the supply agreement to ensure full identification of fee for service items and any limitations of capability.

Quality agreements need to be prepared by the QA people for both parties, and relevant operational personal should be involved, including lab and manufacturing teams. The quality agreement terms should be approved by the QA and operations departments for both parties. Legal does not necessarily have to be involved iwth the quality agreement; The legal department would ensure the quality agreement is in agreement with the supply agreement. But it could delay the execution of your quality agreement.

Generally, quality agreements can save a lot of money and time by preventing critical misunderstandings between contractors and contract givers, but only if the quality agreement is thorough, timely and there has been input from all operational units affected by the quality agreement.

It should be noted, however, that while companies should prepare quality agreements, they also need to have robust quality systems in place to ensure manufactured and distributed products are FDA-compliant. It is the responsibility of the pharmaceutical company doing the outsourcing to a contractor to ensure that the drugs are fully compliant with CGMPs.

We are holding a popular Quality Agreement webinar in May that will teach you exactly how to design your quality agreement to avoid FDA scrutiny and problems. Check it out here!


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