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发表于 2014-9-5 16:55:21
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【续16#】
2.WHO-GMP网址http://www.who.int/medicines/are ... ance/production/en/
相关PDF全有,清单如下:
WHO good manufacturing practices
WHO good manufacturing practices for pharmaceutical products: main principles
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Annex 2, WHO Technical Report Series 986, 2014
Frequently Asked Questions: Good Manufacturing Practice (GMP) in Pharmaceutical Practice
Active pharmaceutical ingredients (bulk drug substances)
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Annex 2, WHO Technical Report Series 957, 2010
Pharmaceutical excipients [pdf 7Mb]
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Annex 5, WHO Technical Report Series 885, 1999
WHO good manufacturing practices for sterile pharmaceutical products
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Annex 6, WHO Technical Report Series 961, 2011
Biological products
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Annex 3, WHO Technical Report Series 822, 1992
WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization)
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Annex 4, WHO Technical Report Series 961, 2011
Pharmaceutical products containing hazardous substances
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Annex 3 WHO Technical Report Series 957, 2010
Investigational pharmaceutical products for clinical trials in humans [pdf 4Mb]
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Annex 7, WHO Technical Report Series 863, 1996
Herbal medicinal products
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Annex 3, WHO Technical Report Series 937, 2006
Radiopharmaceutical products
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Annex 3, WHO Technical Report Series 908, 2003
Water for pharmaceutical use
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Annex 2, WHO Technical Report Series 970, 2012
WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
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Annex 5, WHO Technical Report Series 961, 2011
Validation
pdf, 272kb
Annex 4, WHO Technical Report Series 937, 2006
Risk analysis
Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals
pdf, 103kb
Annex 7, WHO Technical Report Series 908, 2003
Technology transfer
WHO guidelines on transfer of technology in pharmaceutical manufacturing
pdf, 156kb
Annex 7, WHO Technical Report Series 961, 2011
Training materials
Quality Control laboratory training modules
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