A quality agreement should indicate which party will determine the specifications of the components and which party will define procedures for reviewing, qualifying and tracking component suppliers. It is also necessary to determine who will perform the tests or samples necessary to comply with the PMCs. Quality assurance should prepare the agreement with manufacturing and laboratory staff on both sides. The functions of the SQ of both parties should review and approve the quality agreement. Nothing should be taken for granted. Each party must review the quality agreement to ensure that its requirements are taken into account. A compliant pharmaceutical quality system generates and evaluates a significant amount of data. While all data have a general impact on GMP compliance, different data will have different effects on product quality. The agreement should clearly define routine, escalation and emergencies and how they will be treated. The agreement must also define what happens in the event of disputes that may be raised by both parties and document the mechanism for the prompt and effective resolution of disputes. For example, in the case of a batch exit decision, the data that determines compliance with critical quality attributes is more important than inventory cleaning data. The ability to verify whether a computerized system is suitable for its purpose is to define users` needs and to conduct a gap analysis to determine the validation load for retrospective validation. These user requirements should be verified.
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 an CMO, depending on the nature of the relationship between the two parties and the products and services concerned, should relate, to varying degrees, to the following aspects: where the relevant national authorities set additional national expectations with respect to reporting quality defects and reporting deadlines notification. should be respected. To avoid misunderstanding, a glossary that defines keywords, acronyms and abbreviations is essential. It is essential that everyone knows what is meant by any term used in the quality agreement. This is especially true when contracts with non-U.S. companies. terminology can be very different. Make sure you clearly define all referenced documents.
There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, which are tailored to the relevant aspects of the type of relationship.