Quality Technical Agreements (QTAs) are not just a nice-to-have; there is a regulatory requirement to have them established! QTAs are established with manufacturers, suppliers and service providers to obtain written agreements of the details of activities to be provided and the associated requirements and controls. Each agreement type should be tailored to address the
GMP Requirements in the EU: The contents of this article will discuss GxP, Good Manufacturing Practice, Good Distribution Practice and Market Authorisation Holder compliance overview. EU requirements differ from those anywhere else in the world. To import a product into the EU you must abide by European GMP requirements. There is
Why do you need a QP? According to European regulations, no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years
