Q5 Quality of Biotechnological Products Guideline
by 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 …
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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 …
ICH Quality Guidelines
Q1A – Q1F Stability Q2 Analytical Validation Q3A – Q3E Impurities Q4A – Q4B Pharmacopoeias Q5A – Q5E Quality of Biotechnological Products Q6A – Q6B …
Purified Water
Water is life, and ensuring that the water we consume is pure and clean is vital for our health and well-being. With increasing concerns about …
Dissolution Medium Identification for Method Development
Disso media identification is a critical aspect in the development of dissolution testing methods, especially for pharmaceuticals. The goal of dissolution testing is to simulate …
Top 10 Pharmaceutical Company in india
Below, we have sorted India’s top 10 pharma companies listed on the NSE according to their market caps, 1. Sun Pharma Sun Pharmaceutical Industries Limited …
Planning and Procedure for Regulatory Audits
Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically by Regulatory Agencies.
Gap Analysis For Regulatory Complience
Check the list of the documents of the respective department and identify the areas to be analyzed for gap, according to the criticality of the …