In short, the fda expects “owners” to enter into quality written agreements with “contractual bodies” in which the parties define and define the roles and responsibilities of each party in ensuring the production 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. Many comments related to the terms “owner” and “contract establishment.” While it was recommended in some comments that these guidelines adopt the terms “contractor” and “non-contract,” these conditions do not correspond to our objective of showing how parties to a manufacturing contract can cooperate in defining, establishing and documenting agreements, representing production activities and ensuring compliance with PMCs. With this final guide, the FDA has clarified its scope, particularly with respect to the parts to which it applies. You will find a detailed context on this topic in our blog post on the draft guidelines (here). The FDA encourages contract manufacturing parties to implement quality management practices. These guidelines build on the quality management principles and recommendations set out in the Employment and Quality Guidelines to illustrate key elements of the design and implementation of quality agreements that describe and support manufacturing agreements. Another major problem with the board is their lack of specificity. The debate on the applicability of international standards of good practice ICH Q7, Q9 and Q10 tends to remain at a high level, rather than highlighting the key elements of the international guidelines that need to be addressed. The ICH guidelines do an excellent job in developing the problem, but they do not contain practical approaches to the application of the concepts they convey.
The FDA`s new guidelines would have been an excellent opportunity to provide examples of how these approaches should be articulated as part of the quality agreement.