News/Events

IPEA Issues fifth Certificate of Excipient GMP Conformance

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.

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IPEA Issues Certificates for Dow Propylene Glycol USP and Dipropylene Glycol LO+

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.

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IPEA Announces: Second Excipient GMP Certification-Grace Davison, Sorocaba, Brazil

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.

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International Pharmaceutical Excipients Auditing, Inc. (IPEA, Inc.) Excipient GMP Conformance Certification Program accredited by ANSI
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. Click here for more on the Certification Program.
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IPEA Certification for Conformance to Excipient GMP

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.

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