| 000 -LEADER |
|---|
| fixed length control field |
nam a22 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20191126170547.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
181019b xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
1574910795 |
| 040 ## - CATALOGING SOURCE |
|---|
| Transcribing agency |
AIKTC-KRRC |
| 041 ## - LANGUAGE CODE |
|---|
| Language code of text/sound track or separate title |
ENG |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Edition number |
DDC23 |
| Classification number |
615.19 |
| Item number |
CLO |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
|---|
| 9 (RLIN) |
4764 |
| Personal name |
Cloud, Phil |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Pharmaceutical equipment validation |
| Remainder of title |
: The ultimate qualification guidebook |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
New York |
| Name of publisher, distributor, etc. |
Informa Healthcare |
| Date of publication, distribution, etc. |
2007 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
v, 443p. |
| Other physical details |
| Binding- Hard Bound | |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. |
| Expansion of summary note |
No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| 9 (RLIN) |
4765 |
| Topical term or geographic name entry element |
PHARMACEUTICAL ANALYSIS |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Koha item type |
Text Books |
