TY  - BOOK
AU  - Haider,Syed Imtiaz
TI  - Pharmaceutical master validation plan: the ultimate guide to FDA, GMP, and GLP compliance 
SN  - 1574443305 (alk. paper)
AV  - RS192 .H3533 2002
U1  - 615.19021873  
PY  - 2002///
CY  - Boca Raton
PB  - St. Lucie Press
KW  - Pharmaceutical technology
KW  - Quality control
KW  - Pharmaceutical industry
KW  - Drug Industry
KW  - standards
N1  - Includes bibliographical references and index; TOC; 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; Pharmacy
N2  - 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

UR  - http://www.worldcat.org/title/pharmaceutical-master-validation-plan-the-ultimate-guide-to-fda-gmp-and-glp-compliance/oclc/48093011&referer=brief_results
UR  - http://lib.ewubd.edu/ebook/5224
ER  -