A Guide to Good Manufacturing Practices (GMP)

This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP GMP). It is the perfect size to introduce new professionals to the tenets of GMP, highlighting Key areas and practices. It is also a useful refresher for more experienced professionals.

The first pages provide clear explanations of cGMP, cGxP and so on. Key drivers are examined along with the essentials of Quality Management. One of the most important tools in GMP Methodologies is applying a "Process Approach" to systems, manufacturing and all quality impacting activities within an organization.

If you wish to grasp key terminology and the core principles of GMP, this book is for you.

It is a tool that can be used in GMP Training, GMP Induction, Auditor Training and Compliance training.

The book concludes with some review questions to test your knowledge, followed by worked answers.

Full Contents:
What is GMP?
Abbreviation Explainer
Definitions of GMP
Key Elements of GMP
Drivers of GMP
Implementing GMP
Principles of Quality Management
A closer look-QMS
Consequences of poor GMP
Plan-Do-Check-Act
Focus Areas of GMP
Who enforces GMP?
What is a Notified body?
What is a competent Authority?
Examples of Competent Authorities…
Useful Definitions
References
Test Your Knowledge