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.
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.
