To assure patient safety, the manufacture and distribution of pharmaceutical products is highly regulated with the EU. QPs must have a comprehensive knowledge of EU Directives and National legislation relating to the manufacture, storage and sale or supply of medicinal products. QPs also need to demonstrate a thorough knowledge of GMP requirements. This module also covers the requirements for site and product authorisations, regulatory inspections, the role of the
Pharmacopoeias and international harmonisation.
Pharmacopoeias and international harmonisation.
