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2011
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2 . 2
3 . 2
4 .. 2
4.1 .. 2
4.2 .. 2
4.3 (GMP). 2
4.4 .. 2
5 . 2
5.1 ... 2
5.2 .. 2
5.3 .. 2
5.4 .. 2
5.5 .. 2
6 . 2
6.1 .. 2
6.1.1 .. 2
6.1.2 .. 2
6.1.3 .. 2
6.1.4 .. 2
6.1.5 ... 2
6.2 .. 2
7 . 2
7.1 .. 2
7.2 .. 2
7.2.1 .. 2
7.2.2 .. 2
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7.2.3 .. 2
7.2.4 .. 2
7.2.5 ... 2
8 . 2
8.1 .. 2
8.2 .. 2
8.3 (). 2
8.4 ... 2
8.5 : 2
8.6 ... 2
8.7 .. 2
8.8 .. 2
8.9 , ... 2
9 . 2
9.1 ... 2
9.2 .. 2
9.3 .. 2
9.4 .. 2
9.5 .. 2
9.6 .. 2
10 ( ). 2
10.1 ... 2
10.2 .. 2
10.3 .. 2
10.4 .. 2
10.5 . 2
11 . 2
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(GMP) , GMP (European Community), (), .
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2.0-2005 .
2.4-2000 .
2.18-2003 . . , ,
2.21-2001 .
2.30-2001
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12916-89 01.07.1990 .
14644-1-2002 . 1. .
17527-2003
23255-78 01.07.79 .
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51-2002 . .
, .
3.1 (risk analysis): .
3.2 ( ) (reconciliation): .
3.3 (cylinder): .
3.4 (cell bank):
(cell bank system): , , ( ).
(master cell bank): ( ), , , .
(working cell bank): , .
3.5 (Seed lot):
(Seed lot system): , ().
(Master seed lot): , , .
(Working seed lot): , .
3.6 (biological agents): , , , .
3.7 (validation): , , , / .
3.8 (process validation): , , , , .
3.9 (, ) (in process control): , , , , . .
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3.10 (return): , , .
3.11 (air-lock): , , , , .
3.12 (process aids): , .
3.13 : , ( , / ).
3.14 (parametric release): , , , , GMP , , , .
3.15 (finished product): , , .
3.16 (product specification file): , , , , , .
3.17 (order): , / .
3.18 (contained area): , ( ) , , .
3.19 (containment): .
3.20 (simulated product): , , , (, , , .), , . ( ).
3.21 () (procedures): , , .
3.22 (infected): .
3.23 (investigator): , , , .
3.24 (starting material): (, ), , .
3.25 (calibration): , , , , () , .
3.26 (quarantine): , , , , , , .
3.27 (qualification): , , .
3.28 ( installation qualification (IQ ): , , , , (, , ), , , , .
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3.29 (design qualification ): , .
3.30 (operational qualification - OQ): , , , , .
3.31 (performance qualification): , , .
3.32 (clinical trial): , , / , .
3.33 (manifold): , .
3.34 (computerized system): , , .
3.35 (contamination): , , , , .
3.36 (controlled area): , , .
3.37 (in-process control): , , .
3.38 (change control): , , , . , .
3.39 (quality control): .
3.40 (cryogenic vessel) - .
3.41 (acceptance criteria): , , .
3.42 ( critical): , , , , .
3.43 (critical process): , .
3.44 (cell culture): , in vitro, .
3.45 (investigational product): , .
3.46 (herbal medicinal product): , .
3.47 () (validation protocol): , () .
3.48 (measurement procedure): , , .
3.49 (worst case): , , , . .
3.50 (-) (bulk product): , , ().
(batch number (or lot number): , - , .
3.51 (deviation): .
3.52 : , ( ).
3.53 (cross contamination): , , .
3.54 (reprocessing): , , , .
3.55 (prospective validation): , , .
3.56 : , .
3.57 (comparator product): , .
3.58 (impurity): , , .
3.59 (manufacturer): , .
3.60 (master formula): , , .
3.61 (intermediate product): , , .
3.62 (records): , , , , .
3.63 (radiopharmaceutical): , ( ), .
3.64 (re-validation): , (), , .
3.65 ( ) (recovery): .
3.66 : , , .
3.67 (retrospective validation): , .
3.68 (batch (or lot)): , , , .
3.69 (liquefiable gases): , .
3.70 (system): , . , .
3.71 () (signtd signature): , , , .
3.72 (impurity profile):
3.73 (specification): , , , , , , .
3.74 ( sponsor): , / .
3.75 : , , .
3.76 : , , , / , ( ) .
3.77 (standard operating procedure (SOP): , , , , , , , , , , .
3.78 : , .
3.79 ( sterility): .
3.80 (concurrent validation): , () , .
3.81 (manufacturing formulae, processing): - , , , , [19].
3.82 (and packaging instructions): , .
3.83 ( packaging): , , (-), ( , - ).
3.84 (packaging material): , . , .
3.85 (clean area): , , , , .
4.1.1 , , - , [6].
4.1.2 - , . , .
4.1.3 , .
4.1.4 , (Quality Assurance) (Quality Control), GMP, , . , , . - (Qualified Persons).
4.1.5 , , , , , .
4.1.6 , .
4.1.7 - , , , .
4.2.1 (GMP) ( - GMP) .
4.2.2 , :
- ;
- , ;
- ;
- , ;
- , , , , ;
- ;
- , (), , ;
- , ;
- / , .