Excipient Auditing Program is Accredited by ANSI

May 12, 2010
Certification is open to all excipient manufacturers, whether or not the excipient is compendial.

IPEA, International Pharmaceutical Excipient Auditing, a subsidiary of the International Pharmaceutical Excipients Council-Americas (IPEC), 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, means that it conforms 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.

IPEA recently completed its first-ever excipient good manufacturing practice (GMP) certification for Silicon Dioxide NF at Grace Davison’s facility in Baltimore. IPEA Certification assures excipient manufacturers that they are in substantial conformance with the IPEC/Pharmaceutical Quality Group (PQG) excipient GMP guide, a recognized global document for excipient manufacturers.

The IPEA certification program is designed to give drug manufacturers confidence that the quality system of the excipient manufacturer satisfactorily conforms to excipient GMPs. IPEA says that Excipient GMP Conformance Certification is open to all excipient manufacturers, whether or not the excipient is compendial.