GMP Requirements for Excipients
Blue Inspection Body has extensive experience in auditing of manufacturers of all kinds of excipients. Our professionally trained auditors are familiar with both the normative quality management systems (ISO 9001, ISO 13485, ISO 15378 etc.) and the GMP domain; hence, they are able to set the main goals of an audit in a reasonable and risk-based manner.
The EXCiPACT GMP- / GDP-Standard and the related certification scheme represent a new basis for the professional and independent qualification of excipient suppliers by accredited certification bodies. The EXCiPACT certification scheme is an initiative of industrial associations from excipient and pharma suppliers. The initiative provides a framework for the regular monitoring of excipient suppliers by qualified Third-Party audits from the accredited certification bodies. The resulting EXCiPACT certificate and the respective audit report may be issued from the excipient supplier to his pharmaceutical customers.