05 – Pharmaceutical Auditing (3rd edition)

2023 revised and expanded edition.

The quality of medicinal products results from the sum of many activities. End product testing alone is not sufficient to ensure product quality; an overall pharmaceutical quality system is required that builds in the quality. Quality auditing is a key management tool for monitoring and evaluating compliance and the delivery of the pharmaceutical quality system objectives, for driving continual improvement as well as assuring patient safety.

This monograph has been extensively revised and expanded to reflect current regulatory requirements and changes in audit practices arising from developments in information and communications technology and Covid-19 pandemic experiences.

Given that the outcome of an audit depends on both the auditor and auditee, this monograph seeks to equip auditees in addition to being a valuable tool for auditors.