The manufacture of medicinal products should be governed by the rules of Good Manufacturing Practice (GMP). These specifications are stipulated in various bodies of rules such as the 21 CFR 210/211, WHO GMP, PIC/S GMP Guide and EU GMP Guideline Part 1 incl. Appendices.
In the context of outsourcing of manufacturing or quality control activities, qualification procedures of contract manufacturers and approval of medicinal products, GMP audits of the manufacture of finished medicinal products represent an important and legally required component of diligence obligations of pharmaceutical companies.
Blue's auditors have versatile hands-on professional experience in auditing, for instance of active ingredients and excipients, packaging as well as of logistics and materials management (GDP). Hence, they contribute a transdisciplinary dimension to GMP audits.
Due to a multitude and variety of the existing dosage forms, the European GMP guidelines are divided into nine general chapters and 20 special appendices. In this way, differences between solid, semi-solid and liquid dosage forms, oral formulations, dermatological preparations and parenteral preparations, as well as further special features, are accounted for, as in the manufacture of
- sterile medicinal products;
- biological medicinal products for human use;
- radioactive medicinal products;
- veterinary medicinal products and veterinary vaccines;
- medical gasses;
- herbal medicinal products;
- investigational medicinal products;
- products derived from human blood or plasma.