What Are Quality Agreements

The document has been updated in the light of the International Conference on Harmonization (ICH) Q10 on Pharmaceutical Quality Systems which requires a revision of the guidance on outsourcing GMP-regulated activities (3). The title of the chapter has been changed from “Contract Manufacturing and Analysis” to “Outsourced Activities” to give regulation a broader scope, especially in light of the globalization of the pharmaceutical industry today. You may also recall a previous column entitled `Focus on Quality` (4), which deals with Annex 11 of the EU GMP on computerised systems (5), which required agreements with suppliers, consultants and contractors for services. These agreements required clear information on the scope of services and a definition of the responsibilities of all parties. At the end of section 3.1, it was also found that IT services are analog (5) – oh my dear! Iii..