2 OARO (ICH Q1 A to F)
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This document provides an overview of International Council for Harmonization (ICH) guidelines related to quality (Q1A to Q1F). It discusses the guidelines for stability testing of new drug substances and products, photo-stability testing, stability testing for new dosage forms, bracketing and matrixing design for stability testing, evaluation of stability data, and stability data packages for climate zones III and IV. The document lists the years various regulatory agencies accepted each of the ICH quality guidelines.
2 OARO (ICH Q1 A to F)
- 1. International Council for Harmonization (ICH) An overview on Quality (Q1A to Q1F) Obaid Ali Civil Service Officer, Member, ISPE, PDA 26 March 2017
- 2. Not the view of DRAP Current judgment No obligation on DRAP Regulatory experience D I S C L A I M E R References US-FDA WHO ICH NRAs
- 3. Stability Q1A – Q1F Analytical ValidationQ2 Impurities Q3A – Q3C
- 4. Pharmacopoeias Q4A – Q4D Quality of Biotechnological ProductsQ5A-Q5E Specifications Q6A – Q6B
- 5. Good Manufacturing Practices (API) Q7 Pharmaceutical DevelopmentQ8 Quality Risk Management Q9
- 6. Pharmaceutical Quality System Q10 Development & Manufacturing of DSQ11 Lifecycle Management Q12
- 7. Cross cutting topics covered under Multidisciplinary e.g. Common Technical Document
- 8. Q1A (R2) Stability Testing of New Drug Substance & Products Feb 2003 EC March 2003 Canada Sep 2003 FDA Nov 2003 Japan Jun 2003
- 9. Stability Testing Protocol for Global Dossier Temperature DurationHumidity I II III IV
- 10. Q1B Photo-Stability Testing of New Drug Substance & Products Nov 1996 EC Dec 1996 FDA May 1997 Canada Feb 1999 Japan May 1997
- 11. Stability Testing Protocol required to Evaluate Light Sensitivity
- 12. Q1C Stability Testing for New Dosage Forms Nov 1996 EC Dec 1996 FDA May 1997 Canada Jan 1999 Japan May 1997
- 13. Stability Testing Protocol for New Formulation & Circumstances where Flexibility exists for reduced data
- 14. Q1D Bracketing & Matrixing Design for Stability Testing of New Drug Substance & Products Feb 2002 EC Feb 2002 FDA Jan 2003 Canada Sep 2003 Japan July 2002
- 16. Q1E Evaluation of Stability Data Feb 2003 EC March 2003 FDA Jan 2003 Canada Sep 2003 Japan June 2003
- 17. Extrapolation of Retest Periods/Shelf Life beyond Real Time Data may be Appropriate Statistical Approaches Data Analysis
- 18. Q1F Stability Data Package in Climate Zone III & IV Jun 2006 Withdrawn 2006 Withdrawn FDA Jun 2006 Withdrawn Japan July 2006