Excipient GMP Conformance Certification
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.
Following is an excerpt from an article that was found in March 2010 in PharmaManufacturing.com:
From Harmonization to Inspections: An FDA Update, A talk with FDA CDER Office of Compliance's Division of Manufacturing and Product Quality about the state of regulatory harmonization, enforcement, and priorities for the future
FDA advocates the use of appropriate excipient CGMP standards by qualified auditors, including those that are members of an independently accredited excipient auditing body. It is essential that drug product manufacturer provide oversight that ensures that their excipient suppliers follow CGMP standards and supply consistent materials. To read full length article click here
IPEA has received accreditation of its excipient certification program from the American National Standards Institute (ANSI). Accreditation of the program, officially called the IPEA Excipient GMP Conformance Certification Program, by ANSI, signifies conformance to the International Organization for Standardization (ISO)/IEC Guide 65 on general requirements for companies and organizations operating product-certification systems. IPEA has satisfactorily addressed the following key areas through the newly accredited certification program:
- 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)
A pharmaceutical company can now rely on certification of their excipient supplier by IPEA to provide adequate assurance the manufacturing site is in substantial conformance with excipient GMP expectations.
Click here to read April 23, 2010 News Release
Public disclosure of relevant Policies, Procedures, and Forms can be found on our Documents page.