The High Tech Manufacturer: Good Manufacturing Practices for Active Substances Used as Raw Materials in Pharmaceuticals

These good practices come from part II of the European guide to good manufacturing practices for medicinal products for human and veterinary use, itself taken from the ICH Q7A guide developed by the international harmonization conference (ICH). These good practices are intended to provide a guide to good manufacturing practices (GMP) for the manufacture of active substances under an appropriate quality management system. They are also intended to provide assistance in ensuring that active substances comply with the quality and purity requirements they claim or are expected to have. In these good practices, "Manufacturing" includes all operations of reception of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, destocking and distribution of active substances as well as any associated controls. The term "Must" indicates the recommendations that are expected to be followed, unless it can be demonstrated that they are not applicable, are supplemented by specific GMP guidelines, or are superseded by other measures.