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IPRNet GMP 遵守査察マニアル

Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01. IPRNet . GMP . : . GMP IPRNet / . GMP/FDA . IMPLEMENTATION DATE. 10/01/01. COMPLETION DATE. 11/01/01.. GMP .. GMP . QC QC .. 1. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01.. 1 .. :GMP .. a) . b) DQ PQ .. c) ; HVAC, .. 1 . 2. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01.. ( , . ).. : .. 2 .. , .. , .. 3. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01.. 4. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01.

Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01 COMPLETION DATE 2011/01/01 1 IPRNet の実施する医薬品の製造の場における GMP 遵守査察マニアル 目的: 医薬品製造施設の査察 このGMP査察マニアルは、IPRNetが行う医薬品を製造する施設のオーディット/査察

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Transcription of IPRNet GMP 遵守査察マニアル

1 Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01. IPRNet . GMP . : . GMP IPRNet / . GMP/FDA . IMPLEMENTATION DATE. 10/01/01. COMPLETION DATE. 11/01/01.. GMP .. GMP . QC QC .. 1. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01.. 1 .. :GMP .. a) . b) DQ PQ .. c) ; HVAC, .. 1 . 2. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01.. ( , . ).. : .. 2 .. , .. , .. 3. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01.. 4. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01.

2 COMPLETION DATE 2011/01/01.. 100% .. 5. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01.. 6. Compliance GMP Manual for Audit of IPRNet for Drug Substance / Drug products Manufacturing IMPLEMENTATION DATE 2010/01/01. COMPLETION DATE 2011/01/01.. ; . ( GC or HPLC).. ( ).. 7.