To avoid misunderstanding, a glossary that defines keywords, acronyms and abbreviations is essential. It is essential that everyone knows what is meant by any term used in the quality agreement. This is especially true when contracts with non-U.S. companies. terminology can be very different. Make sure you clearly define all referenced documents. As stated in the current FDA [US Food and Drug Administration] Quality Agreements Instructions (1), „if all parties clearly understand their roles related to the CGMP and their production obligations, owners who use contract facilities, contract agencies that provide services to owners and, ultimately, patients who take drugs manufactured under these agreements can benefit in many respects … any party involved in the manufacture of a drug is responsible for ensuring compliance with the CGMP for its manufacturing activities.“ This shows how important it is to establish and responsibly define a strong quality agreement. Companies wishing to develop combined products should review the impact of the 21 current Part 4 (9) CFR articles on their quality system and operations, and they should read the FDA`s current guidelines on mixed product requirements (4) to learn more, as the guidelines contain the language for quality agreements. , „Quality agreements can, for example, set expectations for the activities that will be implemented and developed and pending that are necessary to demonstrate compliance.
with special requirements of CGMP … for example, an owner may enter into a production contract for the final combination with a custom manufacturing plant and explain in supplier agreements the responsibilities and approaches of the CGMP for that facility. A standard operating procedure should be put in place to indicate the types of creditors and services for which a quality agreement is required. At a minimum, an agreement must be reached at any time when an OCM is used, as well as with all suppliers of critical materials. They are recommended for suppliers of large quantities of raw materials or components. By establishing a clear technical agreement, both sides know who will be responsible for what, what will avoid conflict and have clearly defined the path to escalation. During the MHRA or FDA inspection of the contract site, the inspectors` main question is how the parties share responsibility, communicate and confirm the GMP`s compliance. With a well-written technical agreement, the contract manufacturer received a prepared response to the investigator.
It is therefore important to learn how to write a GMP technical agreement. In today`s competitive environment, pharmaceutical companies are increasingly outsourcing the production of APIs and formulations. In such contract manufacturing cases, the EU`s GUIDELINES on Good Manufacturing Practices encourage companies to sign a technical agreement defining the roles and responsibilities of the parties concerned with regard to the production and control of medicines.