Dow Chemical's plants earn third party quality certification

Published: 21-Apr-2011

The certification shows the adherence of the facilities to GMP in the manufacture of ingredients

Dow Chemical’s North American manufacturing operations of its newly branded propylene glycol (PG) USP/EP product, DOW PuraGuard, have passed key independent quality audits and earned third-party certification from International Pharmaceutical Excipients Auditing (IPEA).

The certification shows the adherence of the facilities – in Plaquemine, Louisiana and Freeport, Texas – to Good Manufacturing Practices (GMP) based on the Joint International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group GMP Guide for Pharmaceutical Excipients.

DOW PuraGuard PG USP/EP is a clear, colourless, water-soluble and hygroscopic liquid with low vapour pressure that has 99.8% or greater specified purity (assay), non-detectable MEG/DEG and a two-year shelf life. The product is claimed to be among the highest purity PG USP/EP on the market today, and is the only one to have received this third-party IPEA GMP certification.

IPEA is the ANSI accredited Product Certification Body that implements and promotes global use of appropriate IPEC standards for pharmaceutical excipients.

The purity and versatility of the ingredient make it ideal for pharmaceutical products. The company says its ‘security for purity’ programme gives pharmaceutical manufacturers confidence that the excipient product will be acceptable in their formulations, and also may save manufacturers having to perform individual quality audits of Dow’s PG production facilities.

‘IPEA’s independent third-party evaluation process helps ensure that excipients and related components in finished pharmaceutical products meet only the highest appropriate IPEC GMP standards throughout their manufacturing process,’ said Irwin Silverstein, IPEA vp and coo.

Dow has PG plants in two US states in addition to manufacturing sites in Brazil, Germany and Australia.

l www.dow.com

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