第2章
Contents
1.2. 2 30 HHHL HHHHL GLP GMPHHHHH
3. 21 CFR Part 11 8
4. GMP
5. GLP GMP GLP 23 24 HHHHUHHHHHHH HHHHL GLP GMPHHHHH
6. NN Mk HL HH UL EN
7. GLP ID SOP
8. Fo AS FDA Guidance to Inspections of Quality Systems Ref 15 am GLP cGMPH
9. 2 0N 19 20 HH IlHHHHHH HHHHUHHHHHL ON GLP GMP I
10. NM 0 NT or en GLP GLP QAU NB GLP GLP
11. a we SOP ET FDA SOP
12. s FDA FDA OOS cGMP 21 CFR parts 210 and 211 OOS
13. E 0 _ ri 2 eS OR Sr 1 MS i 3 GLP GMPHH
14. AA 0 6 ID GLP FDA EPA
15. GMP gn GMPDU D EW NJABT LP CGMP
16. FDA cGMP cGMP FDA FDA cGMP GMP FDA cGMP URL URL http www fda gov cder dmpq cgmpnotes htm 31
17. M QAU 0 SOP MM GLP MM 1 16 GLP GMPH QAU QAU
18. 1997 SOP Part 11 LT LT LTLTLTO LTLTLTO LTLTLTO I a D a a D LTLTLTO HHHHHHH Don t do this but this I LTL1 LTL1 LT LT LTL1 LTL1 LTL1 LTL1 a a HHHHHHHL HHHHHHHLH UU GLP cGMPH GLP GMP
19. EF 21 22 UL HHHL HHHHHHH HHHL SOPHHHHHL 9 lt 15
20. FDA QAU LO FDA QAU QAUHHHHH KM ee a MM
21. AllT QAU HUHUHHHS 1 GLP GLP SOP QAU QAU GLP NN GLP i 0 0 Fe ee QAU RE ey 14 QAU QAU QAU QA
22. FDA FDA 483 FDA FDA http www fda gov cder warn index htm http www fda gov foi warning htm 1980 FDA 90 Zereth 67 67 50 45 43
23. IIHHHHHL GLP 0 Standart Operating Procedure SOP je 0 SOP HH A IIHHHHH EEO _ lt 1 2 UU GLP cGMPH
24. FO 21 CFR Part 11 Electronic Record and matures ae UL HHHHHL HHHUHHHHHHHL GLP cGMPH
25. 1 18 HHHHHHLH HHHL GLP GMP SOP SOP SOP GLP GLP GLP GLP
26. FDA SOP
27. 3 7 HHHHHHH HHHHHHH HHHHL
28. SOP UU HHHHHL EN SOP s SOP SOP OO 000000 00 0000 4 0SoP000 HHH 004 00 4 HHHHHH HHH 17 5 SOP SOP SOP SOP
29. GLP Standard operating procedures SOPs 5 SOPHHHHHHHHH CE SOP SOP
30. GLP FDA 2 2 26 HL GLP GMPH HH HH routine inspection GLP lt cause ispectiom GLP GMP
31. EU EU European Agen cy for the Evaluation of Medicinal Products EMEA FDA 2 FDA 2 Guide to Inspection of Phar maceutical Quality Control HHHHHHHHHHHH HHHHHHHHHH Fo AS Guide to insDections of pharmaceutical quality control laboratories HH 13 Guide to Investigating Out of Specification31 OOS Test Results HHHUHHHHHHHHHHL 28 HHHHHHHUHHHHHL FO Guide to investigating out of specifications oo0s test results 14 HHHHHHHHH HH GLP GMPH HH HH FDA Guide to Inspection of Pharmaceutical Qual ity Control ge0o7g7o77es FDA Out of Specification
32. HL GLP GMPHHHHH GLPHHHHH llHHHHHHHHHHHLH RG llHHHHHLH Quality Assur ance Unit QAU QAU se QAU we FDA GLP GMPHHHHH GLPE GMPHHHHHHHHHHHHHHHHHHH IIHHHHHHHHHHHHHHHHHHHHHHH HHHHHHHHHHHHHHHHHHHHHHHH HHHHHHHHHHHHHHHHHHHHHHHHH IIHHHHHHHHHHHHHHHHHHHHHHH IIHHHHHHHHHHHHHHHHHHHHHHHH IIHHHHHHHHHHHHHHHHH GLP 1 2 Py QAU
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