September 9, 2021: Pharmaceutical Interview Questions and Answers

#FullFormOfICH #ICHGuidelineCategories #NumberOfQualityGuidelines

1. What is full form of ICH?

Full form of ICH is International Council for Harmonisation (ICH), formerly known as the International Conference on Harmonisation (ICH).

2. ICH Guidelines are divided into how many categories? What are those?

The ICH topics are divided into the four categories below.

Quality Guidelines

Safety Guidelines

Efficacy Guidelines

Multidisciplinary Guidelines

3. How many main topic quality guidelines are published by ICH ?

Q1A – Q1F Stability

Q1A(R2) Stability Testing of New Drug Substances and Products

Q1B Stability Testing : Photostability Testing of New Drug Substances and Products

Q1C Stability Testing for New Dosage Forms

Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Q1E Evaluation of Stability Data

Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV

Q2 Analytical Validation

Q2(R1) Validation of Analytical Procedures: Text and Methodology

Q2(R2)/Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation

Q3A – Q3E Impurities

Q3A(R2) Impurities in New Drug Substances

Q3B(R2) Impurities in New Drug Products

Q3C(R8) Guideline for Residual Solvents

Q3C(R9) Maintenance EWG Maintenance of the Guideline for Residual Solvents

Q3D(R1) Guideline for Elemental Impurities

Q3D(R2) Maintenance EWG Revision of Q3D(R1) for cutaneous and transdermal products

Q3D training Implementation of Guideline for Elemental Impurities

Q3E EWG Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics

Q4A – Q4B Pharmacopoeias

Q4A Pharmacopoeial Harmonisation

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

Q4B Annex 1(R1) Residue on Ignition/Sulphated Ash General Chapter

Q4B Annex 2(R1) Test for Extractable Volume of Parenteral Preparations General Chapter

Q4B Annex 3(R1) Test for Particulate Contamination: Sub-Visible Particles General Chapter

Q4B Annex 4A(R1) Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

Q4B Annex 4B(R1) Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter

4C(R1) Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

Q4B Annex 5(R1) Disintegration Test General Chapter

Q4B Annex 6 Uniformity of Dosage Units General Chapter

Q4B Annex 7(R2) Dissolution Test General Chapter

Q4B Annex 8(R1) Sterility Test General Chapter

Q4B Annex 9(R1) Tablet Friability General Chapter

Q4B Annex 10(R1) Polyacrylamide Gel Electrophoresis General Chapter

Q4B Annex 11 Capillary Electrophoresis General Chapter

Q4B Annex 12 Analytical Sieving General Chapter

Q4B Annex 13 Bulk Density and Tapped Density of Powders General Chapter

Q4B Annex 14 Bacterial Endotoxins Test General Chapter

Q4B FAQs Frequently Asked Question

Q5A – Q5E Quality of Biotechnological Products

Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Q5A(R2) EWG Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Q5B Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

Q6A- Q6B 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 for Biotechnological/Biological Products

Q7 Good Manufacturing Practice

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Q7 Q&As Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Q8 Pharmaceutical Development

Q8(R2) Pharmaceutical Development

Q8/9/10 Q&As (R4) Q8/Q9/Q10 – Implementation

Q9 Quality Risk Management

Q9 Quality Risk Management

Q9(R1) EWG Quality Risk Management

Q8/9/10 Q&As (R4) Q8/Q9/Q10 – Implementation

Q10 Pharmaceutical Quality System

Q10 Pharmaceutical Quality System

Q8/9/10 Q&As (R4) Q8/Q9/Q10 – Implementation

Q11 Development and Manufacture of Drug Substances

Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances

Q12 Lifecycle Management

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Q12 IWG Training on Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management

Q13 Continuous Manufacturing of Drug Substances and Drug Products

Q13 EWG Continuous Manufacturing of Drug Substances and Drug Products

Q14 Analytical Procedure Development Q2(R2)/Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation

Reference: ICH.org

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