Elements Of Effective Quality Agreements
By Steven Sharf, President and Principal Consultant, GMP Concepts
Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.
What is a quality agreement?
A quality agreement is a contract between two parties that defines the role of each in the manufacture, packaging, testing, holding, and/or distribution of product to the marketplace. It is through this document that both the sponsor (contract giver) and the contractor (contract receiver) know such things as who is responsible for investigating complaints; who is responsible for initiating a recall; what is the expectation for completing investigations; who is responsible for releasing material; and who are the key contacts within each organization when a quality issue arises. While there are many elements to a robust quality agreement, I feel the most important is defining the role of each company in communicating change. The quality agreement should be very clear as to the types of changes that require notification (this would apply to contractor-driven changes as well as those initiated by the sponsor), the timeframes for communicating and implementing changes, and the required approvals for change. The amount of detail that goes into a quality agreement will be dependent on the companies involved (mainly on the sponsor’s requirements), the type of work being performed and the relationship between the sponsor and the contractor.