Quality Systems

Sanjay Garg, PhD, is an associate professor at the School of Pharmacy, University of Auckland, Auckland, New Zealand, and a member of the Pharmaceutical Technology Editorial Advisory Board.

Articles

A book guides readers through the regulatory requirements for computerized quality systems.

Quality in, Quality Out

Angie Drakulich was editorial director of Pharmaceutical Technology.

Myth versus Reality: What does Q10 implementation really mean for my company?

Pharmaceutical Quality Systems

A new book explains process analytical technology, drug stability, and quality.

A Path to Quality and Compliance

Henrik Schwartzbach is a Senior Process Technologist at GEA Niro.

Process designs and control strategies can be improved by adopting a risk-based approach to product quality. The author describes how this approach can be applied to spray-drying operations.

A Risk-Based Approach to Product and Process Quality in Spray Drying

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.

Quality Disconnect

Here's a look at some of the most interesting and thematic responses you-our readers-provided for Pharmaceutical Technology's anniversary survey of industry advances and directions.

Innovations Abound

Signature authentication technology has evolved to become a stong tool for improving confidence in verification.

Signature Authentication Can Restore Confidence

San Juan, PR (Apr. 25)-Regulatory and quality issues were prominent discussion topics at this year?s ExcipientFest conference and exhibition.

ExcipientFest Attendees Discuss Regulatory and Quality Concerns

The concept of Acceptable Analytical Practices (AAPs) was developed by the Analytical Technical Group of the Pharmaceutical Research and Manufacturers of America to share information about how the pharmaceutical industry has implemented chemistry, manufacturing, and controls and quality guidances of the International Conference on Harmonization and worldwide regulatory authorities. The AAP process identifies and addresses critical issues in which guidance is lacking, ambiguous, or contradictory. AAPs were designed to provide a forum where one could learn from the experience of experts in pharmaceutical analysis and enhance the understanding of analytical practices that reflect good science and sound regulatory compliance. This article summarizes the discussion points from a meeting regarding the Justification of Specifications topic.

Acceptable Analytical Practices for Justification of Specifications

This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms validation and verification is provided,and general requirements for validation and verification activities are given.The article also emphasizes the importance of knowing when validation or verification is necessary relative to the use of a method to satisfy pharmacopeial article requirements (for which a monograph exists in the pharmacopeia) or for nonpharmacopeial use.

Quality Assurance/Quality Control