Integrating Business Management Processes

Chapter 5

Good Manufacturing Practice

5.1 Introduction

Good Manufacturing Practices (GMPs), also known as current Good Manufacturing Practices (cGMPs), are a series of manufacturing and administrative procedures aimed at ensuring that products are consistently made to meet specifications and customer expectations. The regulations governing GMPs cover a variety of consumer goods such as manufacture, packaging or holding human food (21 CFR 110.3-110.110); manufacture, packaging or holding operations for dietary supplements (21 CFR 111.1-111.610); manufacture, packaging or holding of drugs (21 CFR 210.1-210.3); finished pharmaceuticals (21 CFR 211.1-211.208); cosmetic labelling (21 CFR 701.1-701.30) and medical devices labelling (21 CFR 801.1-801.437) ...