The EU GMP-Guideline is divided into four parts. Chapters 1-9 of Part 4 form the basis for the quality assurance of pharmaceutical products and set out detailed guidelines for Good Manufacturing Practice (GMP). Specific requirements and standards are defined in these chapters, from the qualification of personnel and equipment to the manufacture and testing of medicinal products through to storage and distribution.
A close look at these 9 chapters provides a comprehensive understanding of the basic principles and requirements that manufacturers must follow to ensure the quality, safety and efficacy of medicinal products in the EU.
In our series of e-learning modules, you will learn about the specific requirements for the different areas.
