Good Manufacturing Practices for Pharmaceuticals: GMP in

Good Manufacturing Practices for Pharmaceuticals: GMP in Practice

CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format
Country USA
Brand CREATESPACE
Manufacturer CreateSpace Independent Publishing Platform
Binding Paperback
UnitCount 1
EANs 9781974006328
ReleaseDate 0000-00-00

Country	USA
Brand	CREATESPACE
Manufacturer	CreateSpace Independent Publishing Platform
Binding	Paperback
UnitCount	1
EANs	9781974006328
ReleaseDate	0000-00-00

Good Manufacturing Practices for Pharmaceuticals: GMP in Practice