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01.PIC/S Validation of Aseptic Processing (PI 007-6) 2011 |
02.FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004 |
03.EU GMP Annex 1: Manufacture of Sterile Medicinal Products - revision November 2008 |
04.PIC/S Recommendations on Sterility Testing (PI 0012-3) Sept 2007 |
05.EU GMP Annex 17: Parametric Release |
06.FDA Guide to Inspections of Sterile Drug Substance Manufacturers, July 1994 |
07.FDA Sterilization Process Validation, January 1993 |
08.FDA Guidance for Industry: SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In-Vitro Release Testing and In Vivo Bioequivalence Documentation |
09.Japanese Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processong |
10.PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007 |
11.PIC/S Isolators used for Aseptic Processing and Sterility Testing (PI 014-3) Sept 2007 |
12.FDA Program 7356.002A Sterile Drug Process Inspections |
13.WHO Good Manufacturing Practices for Sterile pharmaceutical products |
14.APIC - Manufacture of sterile active pharmaceutical ingredients - guidance 1999 |
15.WHO Figures to guideline ob GMPs for HVAC-Systems for non-sterile dosage forms |
16.WHO Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (Annex5, TRS 961) |
17.FDA Guidance for Industry: Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide |
18.FDA Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) |
19.FDA Guidance for Industry Use of Sterile Connecting Devices in Blood Bank Practices |
20.FDA Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) |
21.FDA COMPLIANCE POLICY GUIDE Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16) Page 5 |
22.FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products |
23.FDA Guidance for Industry: Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes |
24.FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter |
25.FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter |
26.FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharm |
27.FDA Guidance for Industry: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products |
28.ICH Q4B Annex 8(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter |
29.Eudralex Volume 3 ICH Topic Q4B Annex 4 A Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter |
30.Eudralex Volume 3 ICH Topic Q4B Annex 4 B Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter |
31.Eudralex Volume 3 ICH Topic Q4B Annex 4 C Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter |
32.Eudralex Volume 3 Maximum Shelf-Life for Sterile Products for Human Use after first opening or following Reconstitution CPMP/QWP/ 159/96 Corr. |
03.FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 8: Sterility Test General Chapter |
34.FDA COMPLIANCE POLICY GUIDE Sec. 490.200 Parametric Release - Parenteral Drug Products Terminally Sterilized by Moist Heat |
35.Eudralex Volume 3 ICH Topic Q4B Annex 8 Sterility Test General Chapter |
36.WHO Guideline on Validation (Annex 7: non-sterile process validation) |
37.WHO good practices for pharmaceutical microbiology laboratories (Annex 2, TRS 961) |
38.FDA Guidance for Industry: SUPAC: Manufacturing Equipment Addendum |
39.Eudralex Volume 3 Sterilisation of the medicinal product, active substance, excipient and primary container |
40.EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft) |
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