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

• Q3A(R2): Impurities in New Drug Substances
• Q3B(R2): Impurities in New Drug Products (Concept Paper)
• Q3C(R5): Impurities: Guideline for Residual Solvents (Concept Paper)
• Q3D: Impurities: Guideline for Elemental Impurities (Concept Paper, Business Plan, Work Plan)

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

• Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Concept Paper)
• Q7 Q&As: Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Concept Paper, Work Plan, contribute to the Q7 Q&A document)

8 - PHARMACEUTICAL DEVELOPMENT

• Q8(R2): Pharmaceutical Development (Concept Paper, ICH Q8/Q9/Q10 Training Material)
• Q8/9/10 Q&AsR4: Q8/Q9/Q10 - Implementation (Q8/9/10 Points to Consider (R2), Concept Paper, CH Q8/Q9/Q10 Training Material)

9 - QUALITY RISK MANAGEMENT

• Q9: Quality Risk Management (Concept Paper, Business Plan, ICH Q9 Briefing Pack, ICH Q8/Q9/Q10 Training Material)
• Q8/9/10 Q&AsR4: Q8/Q9/Q10 - Implementation (Q8/9/10 Points to Consider (R2), Concept Paper, CH Q8/Q9/Q10 Training Material)

10 - PHARMACEUTICAL QUALITY SYSTEM

• Q10: Pharmaceutical Quality System (Concept Paper, Business Plan, Presentation on Q10, ICH Q8/Q9/Q10 Training Material)
• Q8/9/10 Q&AsR4: Q8/Q9/Q10 - Implementation (Q8/9/10 Points to Consider (R2), Concept Paper, CH Q8/Q9/Q10 Training Material)

11 - DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES

• Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), (Concept Paper, Business Plan, Audio Presentation)