ICH Pharmaceutical development guideline-Q8

What is ICH Q8 guidelines?
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The ICH Q8 guideline is intended to provide guidance on the contents of Section 3.2. P. 2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4).

1. ICH Pharmaceutical development guideline-Q8 Presented by :-Prof . Vedanshu Malviya P.R.Pote Patil Collage Of Pharmacy Amravati, B Pharm Final Year, 2021-22

2. Content Introduction Pharmaceutical Development Components of Drug Product Drug Product Manufacturing Process Development Container Closure System Microbial Attribute Compatibility C conclusion

3. Introduction The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process.

4. Objective This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the Common Technical Document (CTD) format. To understand the concept of ICH guidelines Q8 To know the importance and study the benefits of ICH guidelines Q8.

5. PHARMACEUTICAL DEVELOPMENT To design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls.

6. Components of Drug Product Drug Substance Excipients

7. DRUG SUBSTANCES “The physicochemical and biological properties of the drug substance that can influence the performance of the drug product and its manufacturability.” Examples of physicochemical and biological properties that might need to be examined include Solubility Water content Particle size Crystal properties Permeability

8. EXCIPIENTS The excipients chosen, their concentration, and the characteristics that can influence the drug product performance or manufacturability. The compatibility of the drug substance with excipients should be evaluated. For products that contain more than one drug substance, the compatibility of the drug substances with each other should also be evaluated.

9. Drug Product FORMULATION DEVELOPMENT Overages PHYSIOCHEMICAL & BIOLOGICAL PROPERTIES

10. FORMULATION DEVELOPMENT Identification of those attributes that are critical to the quality of the drug product. Highlight the evolution of the formulation design from initial concept up to the final design. Information from comparative in vitro studies or comparative in vivo studies that links clinical formulations to the proposed formulation.

11. OVERAGES Overages in the manufacture of the drug product, whether they appear in the final formulated product or not, should be justified considering the safety and efficacy of the product. Information should be provided on the Amount of overage, Reason for the overage (e.g., to compensate for expected and documented manufacturing losses), Justification for the amount of overage.

12. PHYSIOCHEMICAL & BIOLOGICAL PROPERTIES The physicochemical and biological properties relevant to the safety, performance or manufacturability of the drug product should be identified and discussed. This includes the physiological implications of drug substance and formulation attributes.

13. Manufacturing Process Development Address the selection of the manufacturing process and confirm the appropriateness of the components. Appropriateness of the equipment used for the intended products should be discussed. The manufacturing process development programme or process improvement programme should identify any critical process parameters that should be monitored or controlled (e.g., granulation end point) to ensure that the product is of the desired quality.

14. Container Closure System The choice for selection of the container closure system for the commercial product should be discussed. The choice of materials for primary packaging and secondary packaging should be justified. A possible interaction between product and container or label should be considered.

15. Microbial Attribute The selection and effectiveness of preservative systems in products containing antimicrobial preservative or the antimicrobial effectiveness. For sterile products, the integrity of the container closure system as it relates to preventing microbial contamination. The lowest specified concentration of antimicrobial preservative should be justified in terms of efficacy and safety.

16. Compatibility The compatibility of the drug product with reconstitution diluents (e.g., precipitation, stability) should be addressed to provide appropriate and supportive information for the labeling.

17. Conclusion The compatibility of Agencies and Industry are moving from 'blind' compliance to 'science and risk-based' compliance Industry wants this to be global. This evolution is based on process understanding and continuous improvement throughout the product life cycle Traditional process validation being replaced by a much better alternative. Building in quality. - Continuous quality verification and improvement. Moving from Quality by Testing' to Quality by Design' should, in principle, allow significant regulatory flexibility helps both regulators and industry focus on higher risk or added value activities. The drug product with reconstitution diluents (e.g., precipitation, stability) should be addressed to provide appropriate and supportive information for the labeling.

18. References Dr. Fritz Erni : Consensus on New ICH Pharmaceutical Development Guideline, Regulatory Affairs Journal February 2005, page 89-90 Marieke E. Klijn, Jürgen Hubbuch biopharmaceutical formulation characterization and development studies, European Journal of Pharmaceutics and Biopharmaceutics, 10.1016/j.ejpb.2021.05.013,  165 , (319-336), (2021). Ljuba Karanakov,  Jasmina Tonic- Ribarska , Marija Glavas-Dodov, Suzana Trajkovic-Jolevska, Analysis and critical review of ICH Q8, Q9 and Q10 from a generic pharmaceutical industry view point, Macedonian Pharmaceutical Bulletin, 10.33320/maced.pharm.bull.2011.57.010,  57 , (85-96), (2011).