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 -