Regulatory Requirements For Quality Agreements

A quality agreement clearly indicates what is expected of both parties and who will be responsible for almost all aspects of the project. In addition, specific aspects of project costs will be identified, which could result in time and money savings. Robert Iser of PAREXEL Consulting answers questions about regulatory expectations for quality agreements and how companies can ensure the quality and safety of their products. An effective quality agreement identifies specific sites where the contracting entity performs manufacturing operations, including specific services to be provided on each site. Manufacturing quality agreements are comprehensive written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party respects cmIM. One of the most overlooked sections of the FDA`s #quality agreement guidelines is the definition section. It is important to know what is meant by any term, especially for contracts with non-U.S. suppliers, says @MCMasterControl Kurz, the FDA expects “owners” to enter into quality written agreements with “contract agencies,” with the parties defining and defining each party`s roles and responsibilities for the manufacture of drugs and drugs in accordance with current good manufacturing practices. These quality agreements should ideally indicate which party performs which activities and which party is primarily responsible for full compliance with GMOs in accordance with Section 501 (a) (a) (2) (B) of the Act and 21 C.F.R. Parts 210, 211 and 600-680, since these rules may apply to the product or substance in question. To make this clear to our readers, the FDA`s initial statement and the statement implied in the final guide are correct: there is no legal or regulatory requirement for a quality agreement between owners and contract agencies.

That said, we have seen a significant increase in the number of clients seeking written support and negotiating quality agreements between several types of parties – it is clear that the use of quality agreements is both a common industry practice and useful in clarifying specific roles and responsibilities between the parties.