Organic Impurities
by Understanding Organic Impurities: Types, Sources, and Removal Methods organic impurities are contaminants that can affect the quality of substances, from food to pharmaceuticals, and even …
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Validation of Analytical Procedures Q2(R2)
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 …
Evaluation for Stability Data
This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guideline …
Bracketing and Matrixing Design for Stability Testing of New Drug Substances and Products
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 …
STABILITY TESTING FOR NEW DOSAGE FORMS
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 …
Photo stability Testing of New Drug Substances and Products
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 …
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
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 …
ICH Q14 Analytical Procedure Development Guideline
Q14- Analytical Procedure Development. Q2(R2)/Q14 IWG- Training on Validation of Analytical Procedures and Q14: Analytical Procedure Development.
ICH Q12 Lifecycle Management and Q13 Continuous Manufacturing of Drug Substances and Drug Products
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. …
ICH Q10 Pharmaceutical Quality System and Q11 Development and Manufacture of Drug Substances Guideline
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 …