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 GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records. This guide features the expectations and requirements for data integrity and quality management in GMP facilities.

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 ...

Davis continued, “However, as technology advanced, aseptic processing in manned cleanrooms was no longer considered current GMP and ISPE began tracking and communicating new, better methods of sterile ...

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 2024 Annual Meeting & Expo, ISPE's largest event of the year ... "This patient-centered approach means looking beyond industry GMP compliance, to quality management that helps reduce the ...

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 ...

the ISPE 2009 Washington Conference Session series, the Certified Pharmaceutical Industry Professional (CPIP) Online Course series, and the Good Manufacturing Practices (GMP) Online Training ...

"The FDA has been actively promoting a risk-based approach to GMP as part of the 21st Century Initiative," said Bob Best, ISPE President and CEO. "The change in approach to validation and ...

The guide also will include diagrams and detailed text to explain and compare GMP requirements. ISPE intends the new publication to help personnel develop compliant manufacturing solutions and to ...