01854nam a22002417a 4500
20221022090424.0
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9781974006328
AL
eng
23
615.19
COOG
B N Cooper
60099
Good manufacturing practices for pharmaceuticals:
GMP in practice
USA
Createspace Independent Publications
2017
150p.
PB
25x20cm.
Biotechnology
4986
2120.00
₹
2650.00
20%
18-10-2022
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 ManagementChapter 3-PersonnelChapter 4-Buildings and FacilitiesChapter 5-Process EquipmentChapter 6-Documentation and RecordsChapter 7-Materials ManagementChapter 8-Rejection and re-use of materialsChapter 9-ValidationChapter 10- Change Control Chapter 11-Complaints and recalls
Quality Management
60095
Buildings and Facilities
60096
Materials Management
60097
COOPER (B N)
60098
ddc
BK
224900
224900
0
0
ddc
0
0
BT
AL
AL
2022-10-20
Biblios Book Point, Surathkal, Mangalore-575014
2120.00
0
615.19 COOG
076143
2022-10-21
2650.00
2022-10-21
BK