Quality Assurance of Pharmaceuticals : A Compendium of Guidelines and Related Materials - v. 2 : Good Manufacturing Practices and Inspection

This volume draws together the 12 WHO guidelines related to good manufacturing practices (GMP) and to the inspection of pharmaceutical manufacturers and drug distribution channels.

It seeks to facilitate access to the complete body of WHO guidelines and recommendations aimed at ensuring that pharmaceutical products are manufactured in compliance with internationally-accepted standards for quality and safety.

Guidelines are presented in four chapters. The first reproduces the core GMP guidelines, which set out the philosophy and essential elements of GMP and define good practices in production and quality control.

The two guidelines in the next chapter, on starting materials, provide GMP for active pharmaceutical ingredients and for the manufacture of pharmaceutical excipients.

The third chapter reproduces four sets of specialized guidelines for specific pharmaceutical products. The final chapter includes provisional guidelines for the inspection of pharmaceutical manufacturing facilities, aimed at enforcing GMP compliance, and guidelines for the inspection of drug distribution channels, aimed at ensuring that drug quality is maintained throughout the pharmaceutical supply system or distribution network.