Good pharmaceutical manufacturing practice : rationale and compliance / John Sharp.
Material type:
TextLanguage: English Publication details: New York : CRC Press, c2005. Description: ix, 503 p. : ill. ; 26 cmISBN: 0849319943 (alk. paper); 9780849319945Subject(s): Drugs -- Standards -- United States | Drugs -- Standards -- European Union Countries | Pharmaceutical industry -- United States -- Quality control | Pharmaceutical industry -- European Union Countries -- Quality control | Drugs -- Law and legislation -- United States | Drugs -- Law and legislation -- European Union CountriesDDC classification: 615.362178273 LOC classification: RS189 | .S524 2005Online resources: Publisher description | WorldCat details | E-book Fulltext | Item type | Current library | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|---|---|
E-Book
|
Dr. S. R. Lasker Library, EWU E-book | Non-fiction | 615.362178273 SHG 2005 (Browse shelf(Opens below)) | Not for loan | ||||
Text
|
Dr. S. R. Lasker Library, EWU Reserve Section | Non-fiction | 615.362178273 SHG 2005 (Browse shelf(Opens below)) | C-1 | Not For Loan | 21430 | ||
|
Text
|
Dr. S. R. Lasker Library, EWU Circulation Section | Non-fiction | 615.362178273 SHG 2005 (Browse shelf(Opens below)) | C-2 | Available | 21431 | ||
|
Text
|
Dr. S. R. Lasker Library, EWU Circulation Section | Non-fiction | 615.362178273 SHG 2005 (Browse shelf(Opens below)) | C-3 | Available | 21432 |
Browsing Dr. S. R. Lasker Library, EWU shelves, Shelving location: Circulation Section Close shelf browser (Hides shelf browser)
| No cover image available | No cover image available |
|
|
|
|
|
||
| 615.32154 PAM 1992 Medicinal flowers, Puṣpāyurveda medicinal flowers of India and adjacent regions : | 615.32154 PAM 1992 Medicinal flowers, Puṣpāyurveda medicinal flowers of India and adjacent regions : | 615.34 BEM Medicinal plants : | 615.362178273 SHG 2005 Good pharmaceutical manufacturing practice : | 615.362178273 SHG 2005 Good pharmaceutical manufacturing practice : | 615.4023 CAR 1998 Careers in pharmacy / | 615.4023 CAR 1998 Careers in pharmacy / |
Includes bibliographical references and index.
Introduction: status and applicability of US regulations/EU guidelines - general quality issues --
Personnel, organization, and training --
Premises/buildings and facilities --
Contamination and contamination control --
Equipment --
Materials control --
Production and process controls --
Packaging and labeling control --
Holding and distribution --
Laboratory controls --
Records and reports --
Returned and salvaged drug products --
Sterile products manufacture - basic principles --
GMP and quality assurance in sterile products manufacture --
Validation - general principles --
Validation - applications --
Self-inspection and quality audit --
US cGMPs and EC GMP guide - concluding comparison. TOC
Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP Guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices."--BOOK JACKET.
Pharmacy
Abdul Gani
There are no comments on this title.