Pharmaceutical master validation plan the ultimate guide to FDA, GMP, and GLP compliance
by
Haider, Syed Imtiaz.
Title
:
Pharmaceutical master validation plan the ultimate guide to FDA, GMP, and GLP compliance
Author
:
Haider, Syed Imtiaz.
ISBN
:
9781420025392
Publication Information
:
Boca Raton : St. Lucie Press : CRC Press, c2002.
Physical Description
:
xxxi, 176 p. : ill. ; 25 cm.
Contents
:
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.
Subject Term
:
Pharmaceutical technology -- Quality control.
Pharmaceutical industry -- Quality control.
Electronic Access
:
Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
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Online Library | E-Book | 291294-1001 | ONLINE | | Elektronik Kütüphane |