Validation of Active Pharmaceutical Ingredients (Record no. 14891)
[ view plain ]
000 -LEADER | |
---|---|
fixed length control field | 01341nam a2200205Ia 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
fixed length control field | 140223b2001 xxu||||| |||| 00| 0 eng d |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 9781574911190 |
Terms of availability | 0.00 |
082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
Classification number | 615.152 |
Item number | VAL |
245 ## - TITLE STATEMENT | |
Title | Validation of Active Pharmaceutical Ingredients |
250 ## - EDITION STATEMENT | |
Edition statement | 2nd ed |
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
Place of publication, distribution, etc | Boca Raton |
Name of publisher, distributor, etc | CRC Press |
Date of publication, distribution, etc | 2001 |
300 ## - PHYSICAL DESCRIPTION | |
Extent | 588p |
500 ## - GENERAL NOTE | |
General note | Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. The second edition is fully revised, updated, and expanded to include new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. New terminology has been introduced and the old terminology has been better defined to improve the understanding of related concepts and principles. With this book, readers gain a working knowledge of the regulatory process that will facilitate their organization's compliance. |
600 ## - SUBJECT ADDED ENTRY--PERSONAL NAME | |
Personal name | Pharmaceutics |
9 (RLIN) | 108087 |
700 ## - ADDED ENTRY--PERSONAL NAME | |
Personal name | Berry, Ira A. |
Relator term | Editor |
9 (RLIN) | 108088 |
700 ## - ADDED ENTRY--PERSONAL NAME | |
Personal name | Harpaz, Daniel |
Relator term | Editor |
9 (RLIN) | 108089 |
942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
Source of classification or shelving scheme | Dewey Decimal Classification |
Item type | Book |
995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
Origin of item (home branch) (free text) | Pharmacy Reference |
Genre | P0001446 |
Section | 615.152 |
Recipient parent organisation code | P0001446 |
995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
Origin of item (home branch) (free text) | Pharmacy Lending |
Genre | P0003403 |
Section | 615.152 |
Recipient parent organisation code | P0003403 |
No items available.