News/Events

IPEA Issues fifth Certificate of Excipient GMP Conformance

Submitted by Valeria Stewart on Wed, 11/16/2011 - 22:44

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.

IPEA has now issued Certificates of Excipient GMP Conformance for 5 manufacturing sites covering a total of 5 distinct excipients:

Grace Davison, Baltimore, MD: Silicon Dioxide NF

Grace Davison, Sorocaba, Brazil: Silicon Dioxide NF

Dow Chemical Company, Plaquemine, LA: Propylene Glycol USP/EP and Dipropylene Glycol LO+

Dow Chemical Company, Freeport, TX: Propylene Glycol USP/EP and Dipropylene Glycol LO+

Johann Haltermann, Ltd, Houston, TX: Isopropyl Alcohol USP and Hexylene Glycol NF.

IPEA certificates are available at http://ipeainc.com/certification-status as are directions for requesting the certification audit report.

IPEA Inc. is a wholly owned subsidiary of the

International Pharmaceutical Excipients Council of the Americas.

IPEA's Excipient GMP Certification Program is accredited by the

American National Standards Institute.

IPEA offers:

Excipient GMP Conformance Certification
Excipient GMP Audit Program
Excipient GMP Conformance Gap Assessments
Qualification of Excipient Auditors
Auditing Workshops
On Site cGMP Training