There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, which are tailored to the relevant aspects of the type of relationship. Joy McElroy is the founder of McElroy Training and Consultancy, LLC, which provides consultants for various projects as well as field training for pharmaceutical and biotechnology companies around the world. McElroy began his career in the pharmaceutical industry with environmental monitoring and infertility testing, then moved to a monitoring function that oversaw QC. From there, it moved to quality assurance, then to equipment qualification and process validation. In addition to consulting, it develops and provides webinars and seminars in areas such as technical writing, device qualification, cleaning validation, FDA audit preparation and more. You can connect it to LinkedIn. Within the EU, QAGs or technical agreements are not only an expectation, but a requirement governed by legislation such as the 2003/94/EC directives. In recent years, conflicts and misunderstandings have arisen in the pharmaceutical and biopharmaceutical industry between companies and their contractors. Too often, productive labour relations have collapsed, resulting in costly production delays in which companies and contractors compete for roles and responsibilities.
Such conflicts may have their roots in the absence of a solid quality agreement (QAG). QAGs that clearly delineate the responsibilities of good manufacturing practices (GMP) between a sponsor and a contractor can help companies and their contractors avoid certain conflicts. Sections or subsections of QAG may require reformulation, and sometimes a simple change in semantics can eliminate stumbling blocks in negotiations. However, at other times, it may be assumed that a language change significantly alters the content and the sponsor may not be willing to make the amendment. In these circumstances, it is necessary to continue negotiations. Patience in initial efforts usually pays off in the long run, as significant efforts may be required later to correct errors made during the early negotiation process.