Quality Agreements Guidance

On the other hand, the new guide gives a general overview of the areas to be included in a quality agreement. It contains sections relating to manufacturing activities: suppliers and suppliers` quality agreements define the quality conditions of materials or services provided at a production site and used in products or product manufacturing. Service quality agreements define the quality conditions of services provided at a production site and used in the manufacture of products. 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. 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. These agreements may have material and immaterial benefits for all parties throughout the relationship. 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. PTE: What are the FDA`s expectations for quality agreements? Implementation of a quality written agreement can facilitate compliance with the CGMP, and in particular with 21 CFR 211.22 (d), which stipulates that the activities and procedures of the quality unit must be written down. The FDA recommends that owners and contract organizations enter into a written quality agreement to describe their respective roles, responsibilities and activities related to the CGMP in drug manufacturing.


Please signup or login to answer this question.