Before the introduction of CGMP (good current manufacturing process) for dietary supplements, this was the accepted process. The sale and marketing of products was the responsibility of the label brand/distributor, and the manufacture of the product was CMOcase`s responsibility. But times have changed and that is no longer the case. The label brand/distributor can no longer abdicate responsibility for the quality of its products at the CMO. Quality agreements should be developed by the quality assurance functions of both parties, with the participation of the operational staff involved, for example. B manufacturing and laboratory staff. They should be approved by the SQ function of both parties and by the operating department of both parties. The legal division may or may not participate in the quality agreement. The inclusion of the legal division in the preparatory phase would help to ensure that the quality agreement is in line with the delivery agreement; It may, however, delay the performance of the quality contract if the legal department wishes to add unnecessary legal formulations that do not fall within the quality agreement.
One of the many important details of quality agreements are time slots. If a CMO wants a five-day processing period to verify a master batch (MBR) record, this may be helpful because no data is to be verified. However, if the CMO wants a five-day rotation to verify a batch production dataset (RPO), this is not reasonable in most cases. There is simply too much data to check to be able to do a thorough job in five days. 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. Although the FDA has not yet specifically requested, it is clear that current industry practices expect both a quality agreement and a supply agreement to be present in a manufacturing relationship. This predictive practice merely implements in writing the expectations that the parties already have and more clearly defines the responsibilities that, at present, may be misplaced or misunderstood. For both an auditor and the FDA, the presence of these documents shows proactive thinking and a company`s deliberate efforts to address responsibilities rather than simply ignoring them, giving the FDA a “good” impression, essential to passing the exam. Although the industry has prospered for years without these documents, it is clear that for future growth and sustainability, a quality agreement and delivery contract will be required for successful business relationships.
Individuals who need to know the content of the quality agreement to do their job should be included in the review of the agreement, including business development, project managers and legal projects (to ensure compliance with the delivery agreement). A quality agreement clearly indicates what is expected of both parties and who will be responsible for almost all aspects of the project. In addition, specific aspects of project costs will be identified, which could result in time and money savings. In early 2013, Chapter 7 of the EU GIP was redesigned and renamed “Outsourced Activities” to bring it more in line with the ICH Q10 drug quality system. The principle of Chapter 7 is: “Any activity that falls under the GMP guide and is outsourced should be defined, agreed and controlled accordingly in order to avoid any misunderstanding that could lead to an unsatisfactory quality product or operation.