In cases where national competent authorities have additional national expectations regarding the quality defects to be reported and the deadlines for notification, they should be respected. The importance of data integrity for quality assurance and the protection of public health should be integrated into staff training programmes. The possibility of verifying whether a computerized system is fit for purpose is to define the user`s requirements and to perform a gap analysis to determine the cost of validating the retrospective validation. These user requirements should be reviewed. An effective quality agreement defines the specific sites on which the contracting establishment will carry out manufacturing operations, including specific services to be provided at each site. PMCs are issued under the World Health Organization`s certification scheme for the quality of pharmaceutical products operating in international trade to confirm the authorisation status of products. These certificates also confirm the GMP compliance status of the production sites. PCMs are mainly used by companies to support applications for the export of their pharmaceutical products to countries where regulatory systems are less developed. Small devices are usually widely used commercial devices. In these cases, the development lifecycle is primarily managed by the vendor. The pharmaceutical customer should therefore appropriately assess the supplier`s ability to develop software according to common quality standards. Provision should be made for a technical agreement which meets the requirements of Chapter 7 of Part I and Section 16 of Part II of the GMP Guide.
The FDA`s current position on quality agreements is set out in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines explicitly state that manufacturing activities are the most important element of a quality agreement. It highlights the seven most critical areas that should be the subject of a quality agreement and their specific implications in terms of quality and change control. If a separate control laboratory is involved, all relevant roles and responsibilities must be defined. The quality agreement should explicitly specify what data is shared and how it is disseminated. The agreement should clearly define routine, escalation and emergency cases and how they are handled. The agreement should also define what happens in the event of a dispute that may be raised by one of the parties and should document the mechanism for the prompt and effective resolution of disputes. The guide encourages owners to review and approve most changes before they are implemented. However, in certain circumstances, there are modifications that contractors can implement without notifying the owner.
A quality agreement should indicate how all these changes are made and managed. Part of the agreement should address specific product-specific considerations. It should also define how owners pass on knowledge, such as product information and process development, to contracting entities to ensure that manufacturing is compatible with CGMP. The FDA has no specific guidelines regarding quality agreements between medical device companies and the CMOs that provide services to them. However, fda guidelines state that quality agreements should cover activities under 21 CFR Part 820, the Quality System Regulation (QSR) for medical device companies, “where applicable.” Taking into account the inclusion of Part 820 in the Guide, a quality agreement between a medical technology company and a CMO should address the following aspects depending on the nature of the relationship between the two parties and the goods and services concerned: where there is a mutual recognition agreement (MRA) between the countries of establishment and the European Community, the results of GMP inspections carried out by the MRA partner authority are generally recognised by the EU authorities. . . .