Regulatory guidelines for pharmaceutical industry

Details of the Regulatory guidelines for pharmaceutical industry including ICH Quality Guidelines, US-FDA, Eudralex, PIC/S, WHO and ISO for stability analysis, evaluation of impurities, quality risk management and analytical procedure development etc.

ICH Quality Guidelines

Q1 : Stability testing

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

Q3: Impurities

  • Q3A(R2) – Impurities In New Drug Substances
  • Q3B(R2) – Impurities In New Drug Products
  • Q3C(R8) – Guideline for Residual Solvents
  • Q3D(R2) – Guideline for Elemental Impurities

Q4: Pharmacopoeias

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

Q5: Quality of Biotechnological Products

  • Q5A (R1) – 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

Q6: 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 Guide for Active Pharmaceutical Ingredients

Q8(R2): Pharmaceutical Development

Q9 (R1) : Quality Risk Management

Q10: Pharmaceutical Quality System

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

Q12: Technical and Regulatory Considerations for pharmaceutical products lifecycle management

Q13: Continuous Manufacturing of Drug Substances and Drug Products

Q14: Analytical Procedure Development

EudraLex guidelines

  • Volume 4 – Good Manufacturing Practice (GMP) guidelines
  • Volume 1 -EU pharmaceutical legislation for medicinal products for human use
  • Volume 5 -EU pharmaceutical legislation for medicinal products for veterinary use
  • Volume 2 -Regulatory guidelines for medicinal products for human use
  • Volume 6 -Regulatory guidelines for medicinal products for veterinary use
  • Volume 3 -Scientific guidelines for medicinal products for human use
  • Volume 7- Scientific guidelines for medicinal products for veterinary use
  • Volume 8 – Maximum residue limits
  • Volume 9 – Guidelines for pharmacovigilance
  • Volume 10 – Guidelines for Clinical trial
  • Medicinal products for paediatric use
  • Orphan medicinal products
  • Herbal medicinal products
  • Advanced therapies: New medical products that use gene therapy, cell therapy and tissue engineering.
  • EudraBook

US-FDA Guidelines

  • Title 21 CFR Part 210 : Current good manufacturing practice (cGMP) in Manufacturing, Processing, Packing, or Holding of Drugs
  • Title 21 CFR Part 211 : Current good manufacturing practice (cGMP) for finished pharmaceuticals
  • Title 21 CFR Part 11 : Electronic Records; Electronic Signatures – Scope and Application
  • Current good manufacturing practice (cGMP) for outsourcing facilities
  • Current Good Manufacturing Practice (cGMP) for PET Drugs
  • Current Good Manufacturing Practice Requirements for Combination Products
  • Good Laboratory Practice
  • Guidance for Generic Drug Development
  • Process Validation
  • Orange Book
  • Control of Nitrosamine Impurities in Human Drugs
  • Risk for Melamine Contamination
  • Dioxin/PCB Contamination
  • Pyrogen and Endotoxins Testing
  • Testing of Glycerin for Diethylene Glycol
  • Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
  • Non-Penicillin Beta-Lactam Drugs : A CGMP Framework for Preventing Cross-Contamination
  • Risk Management Plans (RMPs) to Mitigate the Potential for Drug Shortages
  • Quality Systems Approach
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
  • Data Integrity and Compliance with Drug cGMP
  • Computerized Systems Used in Clinical Investigations
  • Mechanical Calibration of Dissolution Apparatus 1 and 2
  • Process Analytical Technology – PAT
  • Expiration Dating and Stability Testing of Drugs Containing Iron
  • Preparation of Investigational New Drug (IND) Products
  • Good ANDA Submission Practices
  • bioavailability (BA) and bioequivalence (BE) Study
  • Scale-Up and Post-Approval Changes: SUPAC-IR
  • Scale-Up and Post-Approval Changes: SUPAC-MR
  • 180-Day Generic Drug Exclusivity under the Hatch-Waxman act
  • Labeling OTC Products
  • Drug Master Files
  • Annual Report

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guidelines

PIC/S GMP Guide

WHO Guidelines

WHO GMP Guide

International Organization for Standardization – ISO Guidelines

  • ISO 9001 : 2015 — Quality Management
  • ISO 14001: 2015 — Environmental Management
  • ISO 18001 — Safety & Health Management
  • ISO 45001 — Occupational health and safety
  • ISO 31000 — Risk management
  • ISO 50001 — Energy management
  • ISO 22001 — HAZOP (Hazard and operability study) Standard Management
  • ISO 13485 — QMS standard for the medical device industry
  • ISO 2859 — Inspection Sampling or AQL
  • ISO/IEC 17025 — Testing and calibration laboratories
  • ISO/IEC 27001:2022 —Information security, cybersecurity and privacy protection