31 marzo 2014

Le linee guida ICH

Per avere una panoramiche delle linee guida ICH vi elenco di seguito tutte quelle che potrete trovare sul sito www.ich.org:

1 - STABILITY


  • Q1A(R2): Stability testing on new drug substances and products
  • Q1B: Stability testing: photostability testing of new drug substances and products
  • Q1C: Stability testing for new dosage forms
  • Q1D: Bracketing and matrixing deisgns fo stability testing of new drug substances and products
  • Q1E: Evaluation of stability data (presentation on Q1E)
  • Q1F: Stability data package for registration applications in climatic zones III e IV, è stata ritirata (Q1F Explanatory note, WHO stability guideline)
2 - ANALYTICAL VALIDATION
  • Q2(R1): Validation of Analytical Procedures: Text and Methodology
3 - IMPURITIES
4 - PHARMACOPOEIAS
  • Q4: Pharmacopoeias
  • Q4A: Pharmacopoeias Harmonisation
  • Q4B: Evalutation and Recommendation of Pharmaceutical Text for use in the ICH Regions (Presentation on Q4B)
  • Q4B Annex 1R1: Residue on Ignition/Sulphated Ash General Chapter 
  • Q4B Annex 2R1: Test for Extractable Volume of Parenteral Preparations General Chapter 
  • Q4B Annex 3R1: Test for Particulated Contamination: Sub-Visible Particle General Chapter 
  • Q4B Annex 4AR1: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
  • Q4B Annex 4BR1: Microbiological Examinatin of Non-Sterile Products: Test for Specified Micro-Organism General Chapter
  • Q4B Annex 4CR1: Microbiological Examinatin of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
  • Q4B Annex 5R1: Disintegration Test General Chapter
  • Q4B Annex 6: Uniformity of Dosage Units General Chapter
  • Q4B Annex 7R2: Dissolution Test General Chapter
  • Q4B Annex 8R1: Sterility Test General Chapter
  • Q4B Annex 9R1: Tablet Friability General Chapter
  • Q4B Annex 10R1: Polyacrylamide Gel Electrophoresi General Chapter
  • Q4B Annex 11: Capillary Electrophoresis General Chapter
  • Q4B Annex 12: Analytical Sieving General Chapter
  • Q4B Annex 13: Bulk Density and Tapped Density of Powders General Chapter
  • Q4B Annex 14: Bacterial Endotoxins Test General Chapter
  • Q4B FAQs
5 - QUALITY OF BIOTECHNOLOGICAL PRODUCTS 
  • Q5A(R1): Viral Safety Evalutation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
  • Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
  • Q5C: Stability Testing of Biotechnological/Biological Products
  • Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
  • Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process (Concept Paper)
6 - SPECIFICATIONS
  • Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Decision Tree)
  • Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
7 - GOOD MANUFACTURING PRACTICE
8 - PHARMACEUTICAL DEVELOPMENT
9 - QUALITY RISK MANAGEMENT
11 - DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES







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