Another example: if the quality agreement is “Batch Record Review, five days” requires clarification. Is it a MBR or an RPO? Is it five working days or five calendar days? These are details that can make a big difference. For start-up companies, which are still developing quality systems and operating functions, there is a bonus learning opportunity. The competency matrix identifies processes and procedures that the proponent should urgently formalize in standard operating procedures (SOPS). Some examples: One of the most overlooked sections of the FDA guide is the definition section. It is essential that everyone knows what is meant by any term used in the quality agreement; especially for contracts with non-U.S. companies, the terminology can be very different. Insert abbreviations and acronyms and set documents – one person`s data sheet is another person`s data sheet. Define “outsourcing” and if and when it is acceptable.
A formal corporate guidelines document should clearly state the types of providers and services for which a quality agreement is required. Whenever an OCM/contractor uses, there should be a quality agreement. A quality agreement should exist with all suppliers of critical materials and is also recommended for suppliers of large quantities, for example. B methylcellulose for capsules, column resins, etc. Although QTAs were initially introduced only as quality agreements, I support the current trend that emphasizes the technical aspect of the title, because quality does not exist in a vacuum, but is an integral part of the process and the product that governs it. Recent updates to the FDA`s guidelines on quality agreements for 2016 focus on commercial production, but an agreement should be reached for contractual activities with each CGMP environment. This is why agreements in the cdmo selection process are often negotiated and executed. While established sponsors may insist on using their own MSA and/or QTA, most companies will choose to start CDMO models for a variety of reasons.
However, despite their widespread adoption and available FDA guidelines, there is still an appropriate level of variability between models. Arvilla Trag, RAC, consultant at BioProcess Technology Consultants, has 27 years of experience in the development of new drugs. As President and Policy Advisor of Midwest Consulting Services (MCS) from 1997 to 2016, she prepared dozens of INDs and several modules 3 and 2.3 for BLAs. In addition to the detailed preparation of the bid, Trag conducted more than 250 CGMP compliance audits conducted by contract manufacturers and testing laboratories, conducted due diligence audits for AMs, established several quality manuals, and conducted deficiency analyses in quality systems.