Pharmaceutical master validation plan : the ultimate guide to FDA, GMP, and GLP compliance / Syed Imtiaz Haider.
Material type:
TextPublication details: Boca Raton : St. Lucie Press, c2002.Description: xxxi, 176 p. : ill. ; 25 cm. + 1 computer optical disk (4 3/4 in.)ISBN: - 9781574443301 (alk. paper)
- 9781574443301 (Cloth)
- Pharmaceutical technology -- Quality control
- Pharmaceutical industry -- Quality control
- Pharmacology
- Medicine: general issues
- Manufacturing industries
- Pharmaceutical chemistry & technology
- Drug Industry -- standards
- Drug and Narcotic Control
- Facility Regulation and Control
- Guideline Adherence -- organization & administration
- Quality Control
- Technology, Pharmaceutical -- standards
- 615.19021873 HAI
- RS192 .H3533 2002
| Item type | Current library | Call number | Vol info | Copy number | Status | Date due | Barcode | |
|---|---|---|---|---|---|---|---|---|
| Long Loan | TUS: Midlands, Main Library Athlone General Lending | 615.19021873 HAI (Browse shelf(Opens below)) | 1 | Available | 00214467 | |||
| Long Loan | TUS: Midlands, Main Library Athlone General Lending | 615.19021873 HAI (Browse shelf(Opens below)) | 1 | Available | 00214466 | |||
| Long Loan | TUS: Midlands, Main Library Athlone CD | 615.19021873 HAI (Browse shelf(Opens below)) | CD 973 | 1 | Available | 00214470 | ||
| Long Loan | TUS: Midlands, Main Library Athlone CD | 615.19021873 HAI (Browse shelf(Opens below)) | CD 974 | 1 | Available | 00214471 |
Includes bibliographical references (p. 169-170) and index.
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 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.