STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
by 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 …
ICH Q8 Pharmaceutical Development and Q9 Quality Risk Management Guideline
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 …
ICH Q6 Specification and Q7 GMP Guideline
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 …
Q5 Quality of Biotechnological Products Guideline
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 …
ICH Q4 PHARMACOPOEIAS GUIDELINE
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 …
ICH Quality Q2-Analytical validation and Q3-Impurities Guideline
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 …
ICH Q1 QUALITY STABILITY GUIDELINE
(1). Q1A (R2)-Stability Testing of New Drug Substances and Products (2). Q1B-Stability Testing ( Photostability Testing of New Drug Substances and Products). (3). Q1C-Stability Testing …