What are the quality agreements, why do we need them, who should use them in the serthenen and what should they contain? 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. 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. These agreements required a clear definition of the scope of the service and the responsibilities of all parties. At the end of paragraph 3.1, it was also found that IT services are analogous (5) – oh dear! Communication must also define what happens in disputes that may be raised by both parties. The agreement should document the dispute settlement mechanism and, ultimately, the country`s legal system as a beneficiary of the financial generosity of the two organizations fighting it in court.

Unsurprisingly, I`m in the camp with the great spectroscope “Dick the Butcher” that said, “The first thing we do, kill all the lawyers.” The ICH guide states that “there should be a written and approved contract or formal agreement between the contractor and the contractor that sets out in detail the GMP responsibilities, including quality measures, of each party.”