The quality agreements that are dealt with in this document are not commercial or commercial agreements, so the FDA recommends that quality agreements be separate documents. One element of the CMO`s commitment, which has been hotly debated in the sector, is the quality agreement that, in the new guidelines, “defines and establishes a comprehensive written agreement between the parties involved in drug manufacturing, which defines each party`s manufacturing activities based on how each party will comply with the PMC.” Given that the CMO assumes a much larger share of development responsibility – which is turning into a CDD – many questions have been raised about the content and timing of quality agreements. Indeed, the real usefulness of high-quality agreements has been the subject of debate. Let`s look at the FDA`s new guidelines in this context. It is not uncommon for the sponsor to be closely involved in early development programs where technical insights are fluid. However, in future programs, the proponent can only verify and approve the authorization, making it essential to assess the CMO`s ability to conduct a thorough case analysis. It is not easy to keep up with the FDA`s ever-changing regulatory requirements. In November 2016, the FDA finalized its guidelines for the production of drug contracts and detailed its expectations for quality agreements. The final document outlines the specific steps manufacturers should take to ensure that their contractual organizations meet a higher compliance standard. In addition, this guide allows contractors to better understand what they really need after the end of a quality agreement and thus helps them better position themselves as viable partners.
Finally, both parties will receive a roadmap for potential inspection/verification points that you need to know. Her knowledge, her experience, has made her an engineer, a technical writer and a highly sought-after trainer in both the pharmaceutical industry and the biotechnology industry. Joy specializes in equipment qualification, cleanliness validation, GMP compliance audit, technical writing as well as GMP, audit preparation and SOP writing training, computer system validation and parts compliance. This guide describes the FDA`s current thinking on the definition, implementation and documentation of the manufacturing activities of the parties involved in the manufacture of contract drugs subject to the current requirements for good manufacturing practices (CGMP). In particular, we describe how parties involved in drug manufacturing can use quality agreements to define their manufacturing activities to ensure compliance with PMCs. 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.