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Pharmaceutical master validation plan : the ultimate guide to FDA, GMP, and GLP compliance / Syed Imtiaz Haider.

By: Haider, Syed Imtiaz.
Material type: TextTextPublisher: Boca Raton : St. Lucie Press, c2002Description: xxxi, 176 p. : ill. ; 25 cm. +.ISBN: 1574443305 (alk. paper); 9781574443301.Subject(s): Pharmaceutical technology -- Quality control | Pharmaceutical industry -- Quality control | Drug Industry -- standardsDDC classification: 615.19021873 Online resources: WorldCat details | Ebook Fulltext
Contents:
Table of contents Validation master plan approval page -- 1. Introduction -- 2. Concept of qualification/validation -- 3. Revalidation -- 4. Facility description -- 5. Description of building -- 6. Equipment description -- 7. HVAC description -- 8. Utilities descriptions -- 9. Validation program overview -- 10. Calibration program summary -- 11. Preventive maintenance program summary -- 12. Key standard operating procedures (SOPs) -- 13. Validation of building -- 14. Validation of utility systems -- 15. Process description for dry production facility: Building A -- 16. Process description for liquid and semisolid production facility: Building B -- 17. Process description for parenterals production facility: Building C -- 18. Qualification of process equipment -- 19. Validation of support processes -- 20. Quality assurance/control laboratory validation -- 21. cGMP procedures and programs -- 22. Validation schedule -- 23. Drawings for ABC pharmaceutical plant.
Summary: Summary: This text provides the tools to minimize non-conformance, reduce rework and rejected lots, avoid recall lots, and more easily achieve new drug approval, satisfactory inspections, corporate legal Read more...
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Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-1 Available CD-1153
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Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-1 Not For Loan 19465
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Text Text EWU Library
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Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-2 Available 19466
CDs & DVDs CDs & DVDs EWU Library
Audio Visual
Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-3 Available CD-1155
Text Text EWU Library
Circulation Section
Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-3 Available 19467
Text Text EWU Library
Circulation Section
Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-4 Available 20049
CDs & DVDs CDs & DVDs EWU Library
Audio Visual
Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-4 Available CD-1156
Text Text EWU Library
Circulation Section
Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-5 Available 20050
CDs & DVDs CDs & DVDs EWU Library
Audio Visual
Non-fiction 615.19021873 HAP 2002 (Browse shelf) C-5 Available CD-1157
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615.1901076 SHQ 2000 QA Manual / 615.1901076 SHQ 2000 QA Manual / 615.1901076 SHQ 2000 QA Manual / 615.19021873 HAP 2002 Pharmaceutical master validation plan : 615.19072 KOD Drug formulations manual 615.19072 KOD Drug formulations manual 615.19072 KOD 2001 Drug formulations manual :

Includes bibliographical references and index.

Table of contents Validation master plan approval page --
1. Introduction --
2. Concept of qualification/validation --
3. Revalidation --
4. Facility description --
5. Description of building --
6. Equipment description --
7. HVAC description --
8. Utilities descriptions --
9. Validation program overview --
10. Calibration program summary --
11. Preventive maintenance program summary --
12. Key standard operating procedures (SOPs) --
13. Validation of building --
14. Validation of utility systems --
15. Process description for dry production facility: Building A --
16. Process description for liquid and semisolid production facility: Building B --
17. Process description for parenterals production facility: Building C --
18. Qualification of process equipment --
19. Validation of support processes --
20. Quality assurance/control laboratory validation --
21. cGMP procedures and programs --
22. Validation schedule --
23. Drawings for ABC pharmaceutical plant.

Summary:
This text provides the tools to minimize non-conformance, reduce rework and rejected lots, avoid recall lots, and more easily achieve new drug approval, satisfactory inspections, corporate legal Read more...

Pharmacy

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