Volume 29, Number 3

Table of Contents

Articles

The FDA’s Draft Process Validation Guidance – A Perspective from Industry

This article provides an overview of the draft guidance, the key changes in relation to the 1987 guidance, and reviews its potential impact on the current industry approaches to science- and risk-based design and qualification activities which support the process validation program. 

The Draft Process Validation Guidance – A Perspective from the FDA

This article presents the questions and answers from a recent ISPE Webinar focused on the FDA’s draft process validation guidance. 

A Comparison of the FDA’s Draft Process Validation Guidance and ASTM E2500

by Robert E. Chew
This article provides a comparison of the provisions found in ASTM E2500 versus the expectations for equipment qualification as enunciated in the FDA’s recent draft process validation guidance.

Industry Interview Series: Dr. Jean-Louis Robert

by John C. Berridge
Jean-Louis Robert talks candidly about his role with the International Conference on Harmonization (ICH), the continued importance of harmonizing quality standards both within the ICH regions and beyond, and the need for global implementation of initiatives such as Quality by Design (QbD), design space, and risk management.

PQLI^® – What is it?

by John C. Berridge
This article presents the current status of ISPE’s PQLI initiative. It details how PQLI will provide the global industry with the tools necessary to implement the ICH quality vision.

Global Regulatory Framework Overview: US FDA, EMEA, PIC/S, and ICH

by Kate McCormick
This article provides a general overview of the organizational structures of the US FDA, EMEA, PIC/S, and ICH as they relate to pharmaceutical manufacturing and regulation. The content in this article is sectioned into three Knowledge Briefs, which are available online and free to ISPE Members.

Barrier Isolation History and Trends – 2008 Final Data

by Jack Lysfjord, Michael Porter
This article presents the final data from a survey conducted on the use of barrier isolators for automated fill/finish operations.

Restricted Access Barrier System (RABS) History and Trends – 2007 Final Data

by Jack Lysfjord, Michael Porter
This article presents the 2007 final data of a survey conducted on the use of RABS for automated fill/finish operations for aseptically filled injectable drugs.

Departments

ISPE Update

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