Objective This guideline presents elements for consideration during the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part …

  This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guideline …

A full study design is one in which samples for every combination of all design factors are tested at all time points. A reduced design …

NEW DOSAGE FORMS A new dosage form is defined as a drug product which is a different pharmaceutical product type, but contains the same active …

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 …