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Contract Laboratory Quality Agreement

As a rule, there are only two parties to a quality agreement; They are defined as the contracting authority (d.b. pharmaceutical company or sponsor) and contract acceptance (contract laboratory) according to EU GMP (2). The FDA also refers to “The Owner” and the contractual facility (1). Whatever names are used, there are usually two parties involved in a quality agreement, unless you are by chance the Marx Brothers (the party of the first part, the party of the second part, the party of the 10th part and so on) (9). According to the FDA (1), a quality agreement has at least the following sections: What are quality agreements, why do we need them, who should participate in the de-federation and what should they contain? The following are best practices and potential elements to be included in a quality agreement: ICH Q7, the application of GMP to active pharmaceutical ingredients (APIs), also has section 16 entitled “Contract manufacturing (including laboratories)”. This document was published by the FDA (6) as a `Guidance for Industry` and is part 2 of the EU GMP (7). Section 16 provides that there should be a written and approved contract or formal agreement between an enterprise and its contractors, detailing the GMP responsibilities, including quality measures, of each party. As stated in the title of the chapter, the scope covers all contract laboratories, which implies the conclusion of a contract or formal agreement for services provided to the API manufacturer or a third-party laboratory that performs analyses on its behalf. Most responsibilities flow directly from regulations and guides, and they must be written and followed.1 Both parties (i.e.: Owners and contractors) are responsible for the CGMP activities they carry out.1 GMP activities include controls to ensure quality, raw material safety, medication safety and risk management.1 There will be a number of people within the quality function. of the two organizations involved in the negotiations. and the operation of a quality agreement. As a rule, some of the roles involved could be in the manufacture of pharmaceutical orders, the work of analytical scientists is covered by a quality agreement prepared by the staff of the quality control or quality assurance department and focused on the laboratory analyses provided. But what exactly are quality agreements, why do we need them, who would be involved in the writing and what should they contain? This is where we answer these questions. In this regard, the owner must regularly check the contract laboratory to ensure that the work performed on his behalf is correct, that complete data is generated and that the integrity of the records is preserved during the retention period of the records.

This ensures that there are no unpleasant surprises for the owner when the FDA comes for a warm conversation about the fireplace. A number of resources are available for those interested in further information on quality agreements: an order laboratory produces often out-of-specification (OOS) results and insufficient laboratory analyses. The main cause of the problem is that the method has not been validated under the actual conditions of use defined in point 21 CFR 194 (a) (2): the adequacy of all test methods used must be verified under the actual conditions of use (8). To simplify, the objective of a quality agreement is to manage the expectations of both parties involved from the point of view of the quality of work and compliance with the rules in force. . . .


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October 2021
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