Quality Systems

Articles

The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.

Vintage Pharmaceuticals Receives Warning Letter

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.

A Perspective on Computer Validation

USP's proposed General Chapter 1226 "Verification of Compendial Procedures" aims to provide guidance about the verification process.

Development of a New USP General Information Chapter: Verification of Compendial Procedures

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

The authors dispel common misinterpretations of the United States Pharmacopeia.

Standard Operating Procedures