Apic Quality Agreement Guideline Templates

(12) „Quality Agreement Guideline and Templates,“ version 01, Active Pharmaceutical Ingredients Committee, December 2009, apic.cefic.org/publications/publications.html. The scope of a quality agreement may cover one or more of the following compliance activities: For those who wish to obtain more information on quality agreements, a number of resources are available: according to the FDA (1), a quality agreement contains at least the following sections: I would now like to dwell on some parts 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). In order to reduce the possibility of a misunderstanding, a glossary defining keywords and abbreviations is an essential element of a quality agreement. „The ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredientss guide aims to provide guidelines on good manufacturing practices (GMP) for the manufacture of pharmaceutical active substances (APIs) as part of an appropriate quality management system“ – FDA Guidance for Industry: Q7 Good Manufacturing Practice for Active Guidancecutical Ingredients – Questions and Answers. According to the FDA, a quality agreement is a comprehensive written agreement that defines and defines the obligations and responsibilities of the quality units of each of the drugs subject to the GMP order (1). The FDA notes that a quality agreement is not a commercial agreement covering the terms of a contract, but is prepared by quality staff and focuses solely on the quality of laboratory service provided. 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.