ICH Q7 & Q11
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The document discusses guidelines on ICH Q7 and Q11 related to the manufacturing of active pharmaceutical ingredients (APIs) and the importance of starting materials in the process. It highlights the differences in traditional and enhanced approaches to manufacturing, focusing on the need for good manufacturing practices and a control strategy based on scientific knowledge. The discussion emphasizes the impact of impurities on product quality and regulatory expectations, citing examples of potential genotoxic impurities.
ICH Q7 & Q11
- 1. Discussion Forum on ICH Q7 & Q11 Introduction Dr. Obaid Ali Deputy Director, DRAP Member ISPE, PDA 23 April 2017 (Program A) 21 May 2017 (Program B)
- 2. Not the view of DRAP Current judgment No obligation on DRAP Regulatory experience References US-FDA WHO ICH NRAs DISCLAIMER
- 4. “Platform Manufacturing” How many people are aware with this terminology?
- 5. Can all give same quality of product? There are different types of rice
- 6. Let’s imagine a scenario and think …
- 7. Water coming from supplier Stored in a tank before entering in API Mfg industry Tank has a small hole Will it have impact on API Quality?
- 10. Q7 SM IM API
- 13. What is a Starting Material? Contributes an important structural part of the API Compound well defined in chemical literature (name, chemical structure, chemical/physical properties, and impurity profile) Synthesized by commonly known process Q7
- 14. Re-defining Starting Material Marks the Start of the Manufacturing Process Manufacturing steps before are not described Manufacturing steps before need not be performed with GMP Changes in manufacturing steps before need not be reported to Agency Each Branch of a Synthesis will begin with One or More Starting Materials Q7
- 15. What is an API? A substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a therapeutically active compound (ingredient) Q7
- 16. API- DS, Characteristics Elucidation of structure Impurities Specifications & its justification Analytical procedure Analytical method validation Q7
- 17. API- DS, Characteristics Potentially genotoxic impurities in DS Atorvastatin exists in crystalline and amorphous forms. The amorphous forms are very sensitive to oxidation giving various epoxide degradation products that is considered a structural alert. Q7
- 18. API- DS, Characteristics Potentially genotoxic impurities in DS Oxcarbazepin: Acridine derivatives are potential degradation product of oxcarabazepin that have some DNA binding capabilities Q7
- 19. Development Manufacture Steps designed to reduce impurity 1 2 3 Q11
- 21. Set points & Operating Ranges Trust on process reproducibility Release on meeting established criteria T R A D I T I O N A L
- 22. Science & Risk knowledge Identify & understand process, CQA Develop a Control Strategy & lifecycle E N H A N C E D
- 23. Traditional & Enhanced Approaches are not mutually exclusive One can use any of them or both of them together
- 24. Take Home Message Level of scientific knowledge will determine the confidence and predict the regulatory flexibility