Manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialities and was accepted. The revised text was discussed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 1968 and published as an annex to its twenty-second report. ICH Quality Guidelines for Pharmaceuticals Industry The “ International Council for Harmonisation “, ICH Guidelines are Quality Guidelines, Safety Guidelines, Efficacy Guidelines and Multidisciplinary Guidelines. However, the ICH Quality Guidelines are Key guidelines for the Pharma industry to. Described in ICH Guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) as they pertain to the development and manufacture of drug.

1. Ich Guidelines For Pharmaceutical Manufacturing
2. Ich Quality Guidelines
3. Current Ich Guidelines
4. Ich Guidelines For Pharmaceutical Packaging

1. Download the pharmaceutical guidelines in pdf for pharmaceutical manufacturing developed by pharmaguideline.com. Pharma Manual Download: ICH Guidelines Download.
2. ICH Guidelines ICH Guidelines were created by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities.

The “International Council for Harmonisation“, ICH Guidelines are Quality Guidelines, Safety Guidelines, Efficacy Guidelines and Multidisciplinary Guidelines. However, the ICH Quality Guidelines are Key guidelines for the Pharma industry to maintain Quality and Compliance.

Read never before articles ICH Guidelines for Pharmaceutical Industry

ICH achieved the Harmonisation milestones in the Pharmaceutical Quality through because of Stability studies, Impurities testing, Good Manufacturing Practice (GMP) and Risk management. Total 24 Quality Guidelines are incorporated in ICH Quality. The Quality Guidelines can be identified by the letter ‘Q’. The Guidelines are distributed from “Q1” to “Q14”.

The never before Quality Guidelines Index is mentioned here.

ICH Quality Guidelines, Stability (Q1A – Q1F)

• Q1A(R2): Stability Testing of New Drug Substances and Products
• Q1B: Photo-stability 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

Ich Guidelines For Pharmaceutical Manufacturing

Quality Guidelines, Analytical Validation (Q2)

• Q2(R1): Validation of Analytical Procedures: Text and Methodology
• Q2(R2)/Q14: Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation

ICH Quality Guidelines, Impurities (Q3A – Q3E)

• Q3A(R2): Impurities in New Drug Substances
• Q3B(R2): Impurities in New Drug Products
• Q3C(R6): Maintenance of the Guideline for Residual Solvents
• Q3C(R8): Maintenance of the Guideline for Residual Solvents
• Q3D(R1): Guideline for Elemental Impurities
• Q3D(R2): Maintenance of Q3D(R1) for cutaneous and transdermal products
• Q3D training: Implementation of Guideline for Elemental Impurities
• Q3E: Impurity Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics

Quality Guidelines, Pharmacopoeias (Q4A – Q4B)

• Q4A: Pharmacopoeial Harmonisation
• Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
• Annex-1 (R1): Residue on Ignition/Sulphated Ash General Chapter
• Annex-2 (R1): Test for Extractable Volume of Parenteral Preparations General Chapter
• Annex-3 (R1): Test for Particulate Contamination: Sub-Visible Particles General Chapter
• Annex-4A (R1): Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
• Annex-4B (R1): Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
• Annex-4C (R1): Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
• Annex-5 (R1): Disintegration Test General Chapter
• Annex-6: Uniformity of Dosage Units General Chapter
• Annex-7 (R2): Dissolution Test General Chapter
• Annex-8 (R1): Sterility Test General Chapter
• Annex-9 (R1): Tablet Friability General Chapter
• Annex-10 (R1): Polyacrylamide Gel Electrophoresis General Chapter
• Annex-11: Capillary Electrophoresis General Chapter
• Annex-12: Analytical Sieving General Chapter
• Annex-13: Bulk Density and Tapped Density of Powders General Chapter
• Annex-14: Bacterial Endotoxins Test General Chapter

Quality of Biotechnological Products (Q5A – Q5E)

• Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
• Q5A(R2): 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

Specifications (Q6A – Q6B), Quality Guidance

• Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
• Q6BSpecifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Good Manufacturing Practice (Q7), ICH Quality Guidelines

• Q7Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Q7 Q&AsQuestions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Pharmaceutical Development (Q8)

• Q8(R2): Pharmaceutical Development

Quality Risk Management (Q9), Quality Guidance

• Q9(R1): Quality Risk Management

Pharmaceutical Quality System (Q10)

Q10: Pharmaceutical Quality System

Development and Manufacture of Drug Substances (Q11)

Ich Quality Guidelines

• 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

Lifecycle Management (Q12)

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

Current Ich Guidelines

Continuous Manufacturing of Drug Substances and Drug Products (Q13)

• Q13: Continuous Manufacturing of Drug Substances and Drug Products

Analytical Procedure Development (Q14)

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

Ich Guidelines For Pharmaceutical Packaging

That’s the end of Quality Guidelines from ICH. Stay tuned here for latest updates of Pharmaceutical Guidelines and Pharma Guidance.