News/Events

The International Pharmaceutical Excipient Council of the Americas, (IPEC-Americas) has signed a Letter of Intent to sell its wholly owned subsidiary third party auditing program, IPEA, Inc.

The EXCiPACT™ Certification Scheme was developed by IPEC-Americas, IPEC Europe and the other founding members, the UK Pharmaceutical Quality Group, the European Fine Chemicals Group and the Federation of European Chemical Distributors as a new, voluntary, international scheme that provides for the high quality, independent certification of manufacturers and suppliers of pharmaceutical excipients to prescribed cGMP and cGDP standards, as a means of ensuring patient safety through supplier quality, while minimizing the overall supply chain costs.. 

The next IPEA Auditing workshop will be held October 22-24, 2013 in Arlington, VA. The class is limited to 20 participants and registration is now available on line.

IPEA presenters will be leading one of the FIRST 2-day EXCiPACT™ AUDITOR TRAINING COURSES in the U.S. Nov. 19-20, 2013. This course is intended for individuals with prior GMP audit experience who want to learn about the EXCiPACT™ scheme. It is ideal for excipient suppliers looking to implement a Quality System to EXCiPACT™ GMP and/or GDP Standards. You will learn what auditors will examine, and understand their expectations for conformance to the standards.

On May 7,2012, following an audit of the Huntsman Performance Products Port Neches, TX facility, IPEA’s Certification Board determined that the facility has earned a Certificate of Excipient GMP Conformance for Propylene Glycol USP produced there. 

Progress is being made towards the completion of the second draft ANSI excipient GMP standard, NSF/IPEC-363. This draft should be available for public comment late in this quarter with approval anticipated in 2013. 

The March 13-15 IPEA Excipient GMP Auditing Workshop was well attended. 11 participants were from IPEC-Americas member companies and there were 7 non-members. 

In October, following an audit of the Johann Haltermann Ltd Houston, TX facility, IPEA’s Certification Board agreed with the auditor’s findings and determined that the facility has earned a Certificate of Excipient GMP Conformance for excipients produced there. The certification applies to Isopropyl Alcohol USP and Hexylene Glycol NF.

Following two audits early this year, at Dow Chemical Company facilities in Plaquemine, LA, and Freeport, TX, IPEA’s Certification Board agreed with the auditor’s findings and determined that the facilities have earned Certificates of Excipient GMP Conformance for excipients produced there.

In November, following an audit of Grace Davison’s facility in Sorocaba, Brazil, IPEA’s Certification Board agreed with the auditor’s findings and determined that the facility has earned a Certificate of Excipient GMP Conformance for excipients produced there.

If you are interested in purchasing a copy of a certification audit report click on the report # and fill out a request form. The cost of a report is $500 for IPEC-Americas Member Companies and $750 for non members.