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. 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. The ICH`s industry guide Q10 Pharmaceutical Quality System recommends that the owner, as a member of a pharmaceutical-grade system, ultimately be responsible for ensuring that “processes are in place to ensure control of outsourced activities and the quality of materials purchased.” It shows that these processes involve quality management and critical activities such as: PTE: How can pharmaceutical companies and contract manufacturers enter into quality agreements that clearly clarify the responsibilities of each company? PTE: What are the FDA`s expectations for quality agreements? It is also important to note that, as fda acknowledged in the draft guidelines, the FDA cGMP “does not expressly require owners and contract agencies to document their respective responsibilities in contract manufacturing agreements.” The full quotation from the draft guidelines indicates that derogation and corrective and preventive measures (CAPA) are other potential areas of disagreement. The discrepancies require both the CMO and the sponsor to understand the cause and effects of a QMS process or excursion. The primary responsibility for investigating cases must be clearly expressed in the quality agreement, as well as when and how a sponsor can participate in an investigation. Often, large pharmaceutical and biotechnology companies have formalized survey frameworks that must be applied to deviations, while the CMO can authorize alternative approaches. The ability to reconcile two different requirements is essential to avoid unnecessary disruptions downstream of the commercial supply chain. This is another example in which limiting the scope to commercial programs is a missed opportunity for the Agency.
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. To learn how to optimize the coordination of quality agreements and other order manufacturing functions with digital tools, read the trend letter “3 Ways Contract Manufacturing Organizations Are Looking to Digital Technology to Improve Collaboration.”