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IPEA certifies excipient manufacturers for conformance to Excipient GMPs in accordance with the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. The program provides the pharmaceutical user with confidence that the quality system at the excipient manufacturer satisfactorily conforms to excipient GMPs. Certification by IPEA does not affirm the quality of the excipient meets compendial requirements or manufacturers specification. Since IPEA only certifies conformance of the quality system to the IPEC-PQG GMPs, it remains the responsibility of the user of the excipient to assure the product meets the required specifications prior to use.
IPEA is completing accreditation by the American National Standards Institute (ANSI) to issue certification for conformance to Excipient GMPS. ANSI will confirm that IPEA meets the requirements for conformance to ISO/IEC Guide 65: 1996(E) and in so doing has satisfactorily addressed the following key areas:
• Documented Quality System in conformance with Guide 65
• Demonstrated independence from outside influences (no conflict of interest)
• Qualification of personnel (education, experience, and training)
• Unbiased assessment (independent certification board)
• Security of confidential information
• Established acceptance criteria (available from the Program page)
• Public access to relevant Policies, Procedures, and Forms (Program page)
Upon accreditation, the pharmaceutical company can rely on certification of their excipient supplier by IPEA to provide adequate assurance the manufacturing site is in substantial conformance with excipient GMP expectations.
Excipient manufacturers can find application information on the application page.
Applications can be faxed to IPEA at 703-525-5157 or attached by by email: ipeainc@aol.com
Public disclosure of relevant Policies, Procedures, and Forms can be found on our Documents page.
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