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Good Clinical Practices - ICH GCP


If you are into clinical research already probably you know what it is all about!. Good Clinical Practices

ICH - International Conference of Harmonization

Structure Three countries, USA, Japan and EU, with their 6 founding member parties (EU, EFPIA, MHLW, JPMA, FDA and PhRMA) Observers (WHO, EFTA, Canada) - Non-voting members. IFPMA representative ICH operates via the ICH Steering Committee, i.e. 6 parties & IFPMA.

Parties: - European Commission, European Union (EU)
European Federation of Pharmaceutical Industries Associations (EFPIA)
Ministry of Health, Labour and Welfare, Japan (MHLW)
Japan Pharmaceutical Manufacturers Association (JPMA)
US Food & Drug Administration (FDA)
Pharmaceutical Research & Manufacturers of America (PhRMA)
International Federations of Pharmaceutical Manufacturers Association (IFPMA)

Table of Contents - 8 sections

1. Glossary
2. The Principles of ICH-GCP
3. Institutional Review Board/Independent Ethics Committee (IRB/IEC)
4. Investigator
5. Sponsor
6. Clinical Trial Protocol & Protocol Amendment(s)
7. Investigator's Brochure
8. Essential Documents for Conduct of a Clinical Trial

Finalized Guidelines:

Efficacy (E1 to E12) GCP=E6 (1996)
Quality (Q1 to Q6)
Safety (S1 to S7 & M3)
Multidisciplinary (M1, M2, M4)



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

Analytical Validation

Q2(R1) : Validation of Analytical Procedures: Text and Methodology
Previously: Text on Validation of Analytical Procedures
Validation of Analytical Procedures: Methodology (as Q2B)


Q3A(R2) : Impurities in New Drug Substances

Q3B(R2) : Impurities in New Drug Products

Q3C(R3) : Impurities: Guideline for Residual Solvents


Q4 : Pharmacopoeias

Q4A : Pharmacopoeial Harmonisation

Q4B : Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)

Quality of Biotechnological Products

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

Q5B : Quality of Biotechnological Products : 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 : Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including Decision Trees)

Q6B : Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Good Manufacturing Practice

Q7 : Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Pharmaceutical Development

Q8 : Pharmaceutical Development

Quality Risk Management

Q9 : Quality Risk Management

Safety Topics

Carcinogenicity Studies

S1A : Need for Carcinogenicity Studies of Pharmaceuticals

S1B : Testing for Carcinogenicity of Pharmaceuticals

S1C(R1) : Dose Selection for Carcinogenicity Studies of Pharmaceuticals & Limit Dose

Genotoxicity Studies

S2A : Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals

S2B : Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals

Toxicokinetics and Pharmacokinetics

S3A : Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

S3B : Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies

Toxicity Testing

S4 : Single Dose Toxicity Tests
Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)

Reproductive Toxicology

S5(R2) : New title: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility
Previously: Detection of Toxicity to Reproduction for Medicinal Products
Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products (in S5(R2))

Biotechnological Products

S6 : Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Pharmacology Studies

S7A : Safety Pharmacology Studies for Human Pharmaceuticals

S7B : The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

Immunotoxicology Studies

S8 : Immunotoxicity Studies for Human Pharmaceuticals

Joint Safety/Efficacy (Multidisciplinary) Topic

M3(R1) : Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.

lots to come.. Come back soon


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