The Annual Product review (APR) is one of the most critical and useful tools that a company has in its quality arsenal. If done properly, it will be a decision making tool for validation, production, quality investigations, process optimization, training, and quality systems development. These are just a few of the uses, however, as this paper will endeavor to explain, the uses are unlimited. This paper will discuss the process from both a quality and regulatory perspective, and explain how it is linked into the quality and production departments of a firm.

Peer Reviewed: Validation Management

Peer Reviewed: Data Integrity

INTRODUCTION

“GXP Talk ” provides a forum for compliance practitioners to address issues identified by the readers of the Journal of GXP Compliance. What are the Regulatory Requirement and Expectations for Process Improvements in the Pharmaceutical Industry?

This paper has discusses the implications of the process hold times on microbial growth during pharmaceutical manufacturing. Microbiological risk exists -- especially with biological products. If microbial contamination occurs where microorganisms enter a product in sufficient numbers and if the process hold time is long enough, the process hold time may be problematic.

This study set out to establish the typical sources of product and process knowledge currently used to support decision-making for post-approval changes and continuous improvement strategies.  It explores whether it is standard practice within industry to utilise the prior knowledge available within the CTD to support day-to-day lifecycle management.  It also explores the potential benefits of leveraging the Quality Overall Summary (QoS), Module 2 of the CTD, to support ongoing management of knowledge throughout the commercial manufacturing and post-market operations. 

In recent years there has been a significant increase in the number and types of data integrity issues that have been cited in regulatory inspections by both USA and European (especially MHRA) investigators. This increase has led to the FDA establishing the types of issues that should be considered red flags triggering a more intensive investigation. One of the areas prone to data integrity issues is the pharmaceutical laboratory. This article discusses data integrity issues and how they can be of concern in the laboratory.

Peer Reviewed: Green Validation