Qualifying the EXCiPACT GMP Certification Scheme as a provider of 3rd party audit reports and GMP Certificates

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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 pharmaceutical product.