ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It. The Guide was cultivated by leading experts to help pharmaceutical organizations achieve ...

ISPE was founded in 1980 by a handful of people working within the pharmaceutical industry, partly as a reaction to the U.S. GMP regulation for drugs that was introduced in 1978. The idea was and ...

and provide flexible production suites for GMP manufacturing, laboratories, and a range of supporting utility and warehouse areas. "We thank ISPE for recognizing ElevateBio as a FOYA category ...

The ISPE OSD guide is intended to help establish consistent and minimum parameters for facility design, which address these concerns and meet GMP requirements. The guide provides guidance on ...

Industry group ISPE is partnering with the China Centre for ... and the March 2009 implementation of Annex 1 of the EU GMP, according to an announcement. The course is intended to help ...

ISPE has released Oral Solid Dosage (OSD ... The not-for-profit association says the guide addresses the latest interpretation of GMP requirements, as well as a risk-based approach to regulatory ...

it was awarded the Facility of the Year Award (FOYA) with Honourable Mention, by the International Society for Pharmaceutical Engineering’s (ISPE).