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【转帖】FDA cGMP guidance
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http://u.115.com/file/t318c1a064 PDMA_qa.pdf http://u.115.com/file/t31cacf21 old042fn.pdf http://u.115.com/file/t3cac5ce0d old008fn.pdf http://u.115.com/file/t39db1d515 old006fn.pdf http://u.115.com/file/t3d136f339 old005fn.pdf http://u.115.com/file/t3cec3565b old004fn.pdf http://u.115.com/file/t3ee2ba11e OCLove1dft.pdf http://u.115.com/file/t38eed1ac0 GMP_Phase1IND61608.pdf http://u.115.com/file/t3c556f4dc BARcodeQsAsfnl10-05-06.pdf http://u.115.com/file/t3cca0a8af 8782fnl.pdf http://u.115.com/file/t38304ec0b 8593fnl.pdf http://u.115.com/file/t36b80def1 8352dft.pdf http://u.115.com/file/t3b4139a33 8019dft.pdf http://u.115.com/file/t370eb1217 7654fnl.pdf http://u.115.com/file/t377d84e0f 7494fnl.pdf http://u.115.com/file/t3e7ffb178 7359fnl.pdf http://u.115.com/file/t377c674 7260fnl.pdf http://u.115.com/file/t3933f39db 6911fnl.pdf http://u.115.com/file/t39463f5c1 6419fnl.pdf http://u.115.com/file/t3b1d64ff1 6169dft.pdf http://u.115.com/file/t3e63e0b7e 5882fnl.pdf http://u.115.com/file/t3c98f048 5880fnl.pdf http://u.115.com/file/t3fd1163f3 5831dft.pdf http://u.115.com/file/t3d0d0ed98 5831AttmtR.pdf http://u.115.com/file/t384ede12f 5667fnl.pdf http://u.115.com/file/t38377c517 5519fnl.pdf http://u.115.com/file/t3c8ce7f3c 4341fnl.pdf http://u.115.com/file/t32f265c35 3823dft.pdf http://u.115.com/file/t3103f39fc 3634fnl.pdf http://u.115.com/file/t3bc8ce6d8 3602fnl.pdf http://u.115.com/file/t355308beb 3310fnl.pdf http://u.115.com/file/t33c7ec7a0 1807fn1.pdf http://u.115.com/file/t3d51e2c92 1289dft.pdf http://u.115.com/file/t378b4efee 06d-0331-gdl0001.pdf http://u.115.com/file/t3b740a9d9 02D-0242_gdl0001.pdf http://u.115.com/file/t38e63f61f protcmc.pdf 目录 不能一一对应，主要内容如下 1. Guidance for Industry Bar Code Label Requirements Questions and Answers 2. Guidance for Industry CGMP for Phase 1 Investigational Drugs 3. Guidance Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide 4. Guidance for FDA Staff and Industry Compliance Policy Guides Manual 5. Guidance for FDA Staff and Industry Marketed Unapproved Drugs —Compliance Policy Guide 6. Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities 7. Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products 8. Guidance for Industry Comparability Protocols -Protein Drug Products and Biological Products- Chemistry Manufacturing and Controls Information 9. Guidance for Industry Computerized Systems Used in Clinical Investigations 10. Guidance for Industry Current Good Manufacturing Practice for Medical Gases 11. Guidance for Industry Dosage Delivery Devices for OTC Liquid Drug Products 12. Guidance for Industry Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron 13. Guidance for Industry Formal Dispute Resolution Scientific and Technical Issues Related to Pharmaceutical CGMP 14. Guidance for Industry Investigating Out-of-Specification (OOS) est Results for Pharmaceutical Production 15. Guidance for Industry Manufacturing Processing or Holding Active Pharmaceutical Ingredients 16. Guidance for Industry Part 11 Electronic Records Electronic Signatures — Scope and Application 17. Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance 18. Guidance for Industry Pharmaceutical Components at Risk for Melamine Contamination 19. Guidance for Industry Possible Dioxin PCB Contamination of Drug and Biological Products 20. Guidance for Industry Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment 21. Guidance for Industry Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment Revised Attachments 22. Guidance for Industry Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics 23. GUIDANCE FOR INDUSTRY Prescription Drug Marketing Act (PDMA) Requirements 24. Guidance for Industry Process Validation General Principles and Practices 25. Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations 26. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 27. Guidance for Industry Street Drug Alternatives 28. Guidance for Industry Testing of Glycerin for Diethylene Glycol 29. Guidance for Industry The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) 30. Guidance for Institutional Review Boards Clinical Investigators and Sponsors 31. Guidance PET Drugs — Current Good Manufacturing Practice (CGMP) 新链接： http://u.115.com/file/t318c33ac7 PDMA_qa.pdf http://u.115.com/file/t31cc6985 old042fn.pdf http://u.115.com/file/t3cac76874 old008fn.pdf http://u.115.com/file/t39db36f8d old006fn.pdf http://u.115.com/file/t3d1388db3 old005fn.pdf http://u.115.com/file/t3cec4f0db old004fn.pdf http://u.115.com/file/t3ee2d3ba6 OCLove1dft.pdf http://u.115.com/file/t38eeeb54a GMP_Phase1IND61608.pdf http://u.115.com/file/t3c5588f67 BARcodeQsAsfnl10-05-06.pdf http://u.115.com/file/t3cca2433b 8782fnl.pdf http://u.115.com/file/t39463f5c1 6419fnl.pdf http://u.115.com/file/t38304ec0b 8593fnl.pdf http://u.115.com/file/t36b80def1 8352dft.pdf http://u.115.com/file/t3b4139a33 8019dft.pdf http://u.115.com/file/t370eb1217 7654fnl.pdf http://u.115.com/file/t377d84e0f 7494fnl.pdf http://u.115.com/file/t3e7ffb178 7359fnl.pdf http://u.115.com/file/t377c674 7260fnl.pdf http://u.115.com/file/t3933f39db 6911fnl.pdf http://u.115.com/file/t39463f5c1 6419fnl.pdf http://u.115.com/file/t3b1d64ff1 6169dft.pdfhttp://u.115.com/file/t3e63e0b7e 5882fnl.pdfhttp://u.115.com/file/t3c98f048 5880fnl.pdfhttp://u.115.com/file/t3fd1163f3 5831dft.pdfhttp://u.115.com/file/t3d0d0ed98 5831AttmtR.pdfhttp://u.115.com/file/t384ede12f 5667fnl.pdfhttp://u.115.com/file/t38377c517 5519fnl.pdfhttp://u.115.com/file/t3c8ce7f3c 4341fnl.pdfhttp://u.115.com/file/t3103f39fc 3634fnl.pdfhttp://u.115.com/file/t3103f39fc 3634fnl.pdfhttp://u.115.com/file/t3bc8ce6d8 3602fnl.pdfhttp://u.115.com/file/t355308beb 3310fnl.pdfhttp://u.115.com/file/t33c7ec7a0 1807fn1.pdfhttp://u.115.com/file/t3d51e2c92 1289dft.pdfhttp://u.115.com/file/t378b4efee 06d-0331-gdl0001.pdfhttp://u.115.com/file/t3b740a9d9 02D-0242_gdl0001.pdfhttp://u.115.com/file/t38e63f61f protcmc.pdf [ Last edited by afhgd0901 on 2010-9-29 at 21:13 ] |
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