All activities under the quality agreement must be carried out in accordance with applicable GMP regulations. As this great analytical chemist Ronald Reagan put it, “trust but check” (this is the English translation of a Russian proverb). The review is carried out before the quality agreement and confirms that the laboratory can carry out the work with an appropriate quality assurance system. Then, when the analysis is ongoing, the review confirms that the work is being done to the required standards. The FDA and the EU require the owner or contractor to be controlled by the supervisory bodies to which he entrusts the work. In the field of pharmaceutical manufacturing, the work of analysts is covered by a quality agreement, prepared by the staff of the quality control or quality assurance department, focused on the laboratory analyses provided. But what exactly are quality agreements, why do we need them, who would write them down and what should they contain? Here we answer these questions. I would now like to dwell on certain sections of a quality agreement. I would like to point out that this is my selection and for a complete picture, readers should refer to the source guide (1) or the regulation (2). The API Compliance Institute was established on December 19, 2002. The activities of the API Compliance Institute are based on a contractual agreement between APIC, CEFIC Group, and CONCEPT HEIDELBERG.
It is the responsibility of the API Compliance Institute to standardize GMP audits of API manufacturers and minimize the costs of compliance audits. The scope of a quality agreement may cover one or more of the following compliance activities: ICH Q7, which is the application of GMP to Pharmaceutical Active Ingredients (API), also has Section 16 entitled “Contract Manufacturing (Including Laboratories).” This document was published by the FDA under the title “Guidance for Industry” (6) and is Part 2 of the EU GMP (7). Section 16 states that “there should be a written and approved contract or formal agreement between a company and its contractors specifying the responsibilities of the PMPs, including quality measures, of each party.” As mentioned in the chapter title, the scope covers all contract laboratories, implying that a formal contract or service agreement is required for the API manufacturer or a third-party laboratory that conducts testing on their behalf. That`s why we`re discussing quality agreements in this exciting edition of Focus on Quality about why they are important to laboratories and what they should contain for contract analysis. The principles outlined here should also apply to laboratories accredited to the International Standards Organization (ISO) 17025, as well as service providers to regulated and quality-oriented laboratories. OBJECTIVES Networking/representing interests: continuous improvement of our contacts and strengthening the profile of APIC with all relevant stakeholders. Level Playing Field: the application of legislation in all global markets and their application through inspection. Approval of amendments after approval: put responsibility for managing change in the hands of the industry. Harmonization: support for global harmonization in the areas of quality and regulation.
According to the FDA (1), a quality agreement contains at least the following sections: For those who wish to learn about quality agreements, a number of resources are available: the program was launched on December 19, 2002.