Regulatory measures can be useful if they lead to a higher level of compliance, which reduces the number of violations. The FDA estimates that the owners` liability in their CMOs will lead to fewer compliance problems and, ultimately, fewer regulatory measures. An increase in the number of measures such as warning letters, seizures, prescriptions and prosecutions makes drugs less safe. The FDA`s goal is to ensure public safety and product quality, not to increase the number of enforcement measures. How would a stronger quality agreement and communication plan have helped resolve the situation? There are a few recommendations to make. The first is that if several quality agreements are involved, the client should ensure that each of the parties know each other through its quality agreement. The customer should also specify that it will facilitate any communication between the different parties involved in the manufacture, including test laboratories, conditioners, etc. In addition, quality agreements should specify who is responsible for the various activities, including facilitation and investigations. Do not think that, because there is no explicit requirement for reviewing your suppliers that you will not be written in a heartbeat because they are not a robust audit program and quality audits of your suppliers. There are regulatory requirements for quality agreements.
Although U.S. GMOs are not currently needed for drugs, it is very likely that they will soon. In 2016, the FDA released the policy paper “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The addition of a quality agreement requirement to 21 CFR 211 would make GPS in the United States compatible with European Union (EU) GSPs and FDA-accepted ich guidelines (see below). The FDA does not have a specific policy for quality agreements between medical device companies and CMOs that provide them with services. However, FDA guidelines state that quality agreements should cover activities under Category 21 CFR Part 820, the Quality Assurance Regulation (QSR) for medical device companies, “if applicable.” Given the inclusion of Part 820 in the guidelines, a quality agreement between a medical device company and a CMO should, depending on the nature of the relationship between the two parties and the products and services involved, extend to varying degrees to the following aspects: And in ICH Q10, 2.7: “The pharmaceutical quality system, including the management tasks described in this section , covers monitoring and verification of outsourced activities… Responsibilities for the quality of the donor`s and contractor`s activities should be defined in a written agreement. Part of the agreement should take into account a specific reflection on the different products. In addition, it is necessary to define how owners pass on knowledge, such as . B, from product and process development information to contract entities to ensure that manufacturing is geared towards CGMP. It is wrong to believe that quality agreements are only necessary for the use of CMOs operating in a different regulatory environment. This is not the case – any outsourcing contract should have a related quality agreement, including agreements between different departments of the same company, regardless of the physical location of one of the parties involved.