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. According to the FDA (1), a quality agreement includes at least the following sections: In the Quality Agreement Guide (1), the FDA states that contract laboratories are subject to GMP regulations and discuss two specific scenarios. You can find them here in a preview, see the instructions for detailed discussion. What are the quality agreements, why do we need them, who should use them in the serthenen and what should they contain? Any activity covered by the GMP guide and outsourced should be defined, agreed and controlled accordingly in order to avoid any misunderstanding that could lead to an unsatisfactory quality product or operation. There must be a written contract between the contract giver and the processor that clearly defines each party`s obligations. The contract supplier`s quality management system must clearly state how the qualified person who certifies each batch of products for release exercises full responsibility. The responsibilities of the two groups signing the agreement depend on the extent of the work entrusted to the contract laboratory and the degree of autonomy allowed. If z.B. a laboratory is used to perform one or two specialized tests instead of full validation tests, most of the work remains in the owner`s quality unit. They are in charge of the release process and most of the work.
On the other hand, if the entire work package is entrusted to an OCM, the responsibilities of the control laboratory will be considerably expanded and the communication of the results, especially exceptions, will be more important. The European Union (EU) has published a new version of Chapter 7 of the Good Manufacturing Practices Regulation (BMP), which came into force on 31 January 2013 (2). The document was updated due to the need for revised guidelines for outsourcing BMP-regulated activities in light of the International Conference on Harmonization (ICH) Q10 on pharmaceutical quality systems (3). The title of the chapter has been changed by “Contract Manufacture and Analysis” to “Outsourced Activities” to give the regulation a broader scope, especially given the globalization of the pharmaceutical industry these days. You also remember an earlier column entitled “Focus on Quality” (4), which dealt with Annex 11 of the EU GMP on COMPUTER systems (5), which was needed for services with suppliers, consultants and contractors.