ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design - - BioPharm International

ADVERTISEMENT

ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design



The International Society for Pharmaceutical Engineering (ISPE) announced the publication of a new guidance document on the design of pharmaceutical quality laboratories. The document, titled ISPE Good Practice Guide: Quality Laboratory Facilities, defines design guidelines for quality laboratories supporting GxP-regulated facilities producing pharmaceutical products for human and animal applications.

It is intended to be used to facilitate communication between laboratory owners, engineers, and builders about the function, operation and design parameters that must be met in order to ensure that the finished laboratory is fit for intended use. One of the study authors, James O’Brien, president of NAMA Industries, explains in the ISPE press release, “This new Guide helps put all three parties on the same page and gives owners a better understanding of all of the different considerations they must keep in mind so they can avoid giving incorrect or incomplete instructions to the engineer.”

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GSK Submits EU Regulatory Filing for Malaria Vaccine Candidate
July 29, 2014
Bristol-Myers Squibb and Ono Pharmaceutical Collaborate on Immunotherapies
July 28, 2014
FDA Accepts First Biosimilar Filing
July 24, 2014
Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
Author Guidelines

Click here