According to the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG), the quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate Good Manufacturing Practice (GMP) principles to excipients is essential. In contrast to finished dosage forms and Active Pharmaceutical Ingredients (APIs), there are no specific GMP regulations for excipients. In addition, there are a large number of applications of this diverse range of materials which makes the development of excipient GMP guidelines challenging. However, there is a general expectation that excipients are manufactured to recognised GMP principles.
IPEC – PQG Good Manufacturing Practice Guidelines FOR PHARMACEUTICAL EXCIPIENTS proposes GMP appropriate for the manufacture of excipients. The text of the guidelines aligns with the corresponding clauses in ISO 9001:2008. This Guide proposes to make an essential contribution to the wider understanding and attainment of good manufacturing practice appropriate for the excipient supply industry. Excipient manufacturers and their customers can be assured that excipients manufactured according to this Guide will meet internationally accepted good manufacturing practice principles.
Standards Certification Council offers a complete conformity assessment solution for IPEC – PQG GMP for Pharmaceutical Excipients including training, auditing and certification services. It is also possible to integrate your existing management systems of other standard such as ISO 9001 and ISO 14001, and saving you valuable time and resources.