ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design


ePT--the Electronic Newsletter of Pharmaceutical Technology

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.”

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here