Category: ICH 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 …

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 …

(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 …

Q1A – Q1F Stability Q2 Analytical Validation Q3A – Q3E Impurities Q4A – Q4B Pharmacopoeias Q5A – Q5E Quality of Biotechnological Products Q6A – Q6B …