IAIN MOORE
EXCiPACT asbl, Snaith, United Kingdom

Abstract

There has always been a regulatory requirement for Pharmaceutical manufacturers to audit their starting material suppliers, but with increasing and sustained use of 3rd party audit solutions, pharmaceutical manufacturers will need to qualify not only the excipient manufacturer but also the 3rd party certification scheme owner and any associated organisations that perform the audits. The use of the new IPEC GMP Certification Scheme Certification Body Qualification Guide by EXCiPACT is used to explain an efficient means of qualifying these organisations.

INTRODUCTION
In Europe, the Falsified Medicines Directive (FMD) (1) requires that the medicines manufacturer ensures the excipients they use are suitable for their drug product through the use of a risk assessment approach which is used to determine the required Good Manufacturing Practices (GMP) for the manufacture of each excipient (2). This regulatory approach has now been adopted in full by the Pharmaceutical Inspection Convention (PIC/S) and so it becomes best practice globally (3). The formalised risk assessment works by combining two key elements of the excipient into one overall assessment from which the relevant GMP can be determined. This involves an evaluation of the risks to patient safety from the excipient itself and its purpose in the pharmaceutical product. Key factors here are the quantity that will be in the final drug formulation and the way it helps deliver the active ingredient to the patient. The other dimension concerns the supplier and the GMP that they apply in the manufacture of the excipient. Ultimately the combination of these two factors determines the suitability of the excipient from a specific supplier for that pharmaceutic ...