Category: ICH Guideline

The intrinsic photo stability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in …

Stress Testing Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and …

Q14- Analytical Procedure Development. Q2(R2)/Q14 IWG- Training on Validation of Analytical Procedures and Q14: Analytical Procedure Development.

Lifecycle Management Q12- Technical and Regulatory Considerations for Pharmaceutical Products Lifecycle Management Q12 IWG- Training on Regulatory and Technical Considerations for Pharmaceutical Products Lifecycle management. …

Pharmaceutical Quality System Q10- Pharmaceutical Quality System. Q8/9/10 Q&As (R5) Q8/Q9/Q10- Implementation. Development and manufacture of Drug Substances Q11- Development and Manufacture of Drug Substance …

Pharmaceutical Development Q8(R2)- Pharmaceutical Development. Q8/9/10 Q&As (R5) Q8/Q9/Q10- Implementation. Quality Risk Management Q9(R1)- Quality Risk Management Q9(R1) IWG- 2006-2010 Training on Quality Risk Management …

Specifications Q6A- Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Q6B- Specifications: Test Procedures and Acceptance Criteria …

Q5A(R2)- Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. Q5A(R2) IWG- Training on Viral Safety Evaluation of Biotechnology …

Q4A- Pharmacopoeial Harmonisation. Q4B- Evaluation and Recommendations of Pharmacopoeial Texts for Use in the ICH Regions. Q4B(R1)- Evaluation and Recommendation of Pharmacopoeial Texts for Use …

Analytical Validation Q2(R2)- Revision of Q2(R) Analytical Validation. Q2(R2)/Q14 IWG- Training on Validation f Analytical Procedures and Q14: Analytical Procedure Development. Impurities Q3A(R2)- Impurities in …