Haider, Syed Imtiaz.

Pharmaceutical master validation plan : the ultimate guide to FDA, GMP, and GLP compliance / Syed Imtiaz Haider. - Boca Raton : St. Lucie Press, c2002. - xxxi, 176 p. : ill. ; 25 cm. +

Includes bibliographical references 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 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. Table of contents

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...




1574443305 (alk. paper) 9781574443301

2001048618


Pharmaceutical technology--Quality control.
Pharmaceutical industry--Quality control.
Drug Industry--standards.

RS192 / .H3533 2002

615.19021873 / HAP 2002

QV 736 / H149p 2001

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