| 000 -LEADER |
|---|
| fixed length control field |
01854nam a22002417a 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20221022090424.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
221021b ||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781974006328 |
| 040 ## - CATALOGING SOURCE |
|---|
| Transcribing agency |
AL |
| 041 ## - LANGUAGE CODE |
|---|
| Language code of text/sound track or separate title |
eng |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Edition number |
23 |
| Classification number |
615.19 |
| Item number |
COOG |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
B N Cooper |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
|---|
| 9 (RLIN) |
60099 |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Good manufacturing practices for pharmaceuticals: |
| Remainder of title |
GMP in practice |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
USA |
| Name of publisher, distributor, etc. |
Createspace Independent Publications |
| Date of publication, distribution, etc. |
2017 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
150p. |
| Other physical details |
PB |
| Dimensions |
25x20cm. |
| 365 ## - TRADE PRICE |
|---|
| Source of price type code |
Biotechnology |
| Price type code |
4986 |
| Price amount |
2120.00 |
| Currency code |
₹ |
| Unit of pricing |
2650.00 |
| Price note |
20% |
| Price effective from |
18-10-2022 |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
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 |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Quality Management |
| 9 (RLIN) |
60095 |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Buildings and Facilities |
| 9 (RLIN) |
60096 |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Materials Management |
| 9 (RLIN) |
60097 |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
COOPER (B N) |
| 9 (RLIN) |
60098 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Koha item type |
Book |
