Ich q8 guidelines cadd

cadd sem 2 QD ich q8 guideline

1. ICH Q8 Guidelines . Prepared By :- Arjun S.Dhawale M.Pharm 2 sem Pharmaceutics Kamla Nehru College of Pharmacy Butibori , Nagpur .

2. Content :- Introduction . QbD approach . ICH Q8 R2 guidelines . Contents for CTD module 3 . Compound of drug product . Formulation development . Container and closure system . Microbiological attributes . Compatibility . Conclusion . Reference .

3. Introduction :- This guideline describes the suggested contents for the (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. 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. It is first produced for the original marketing application and can be updated to support new knowledge gained over the lifecycle of a product. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools , and will eventually enable real-time release , regardless of the formulation type .

4. QbD approach :- Quality Target Product Profile (QTPP) : According to the ICH Q8 guideline , QTPP is a prospective summary of the quality characteristics of a drug product to ensure the desired quality , taking into account safety and efficacy of that drug product . Through the scientifically based process of product development , critical process parameters (CPPs) , critical quality attributes (CQAs) of the product are identified .

5. ICH Q8 (R2) :- The ICH Q8 guidelines describes GOOD PRACTICES FOR PHARMACEUTICAL PRODUCT DEVELOPMENT . ICH Q8 Pharmaceutical Development describes the principles of QbD , outlines the key elements , and provides illustrative examples for pharmaceutical drug products . It is often emphasized that the quality of a pharmaceutical product should be built by Design rather that by testing alone .

6. Contents for CTD quality Module 3 :- Components of drug product . Formulation development . Manufacturing process development . Container Closure System . Microbiological Attributes . Compatibility .

7. Components of drug prodt given by ICH Q8 :- Drug substances :- The physicochemical and biological properties of the drug substance that can influence the performance of the drug product and its manufacturing . Excipients :- The excipients chosen , their concentration ad the characteristics that can influence the drug product performance or manufacturing should be discussed relative to the respective function of esch excipients .

8. Formulation Development :- The development of the formulation , including identification of those attribution are critical to the quality of the drug . The product are also highlighted the evolution of the formulation design and initial concept up to the final design . A successful correlation can assiat in the selection of appropriate dissolution acceptance criteria and can potentially reduce the need for further bioequivalance studies following changes to the product or its manufacturing process .

9. Containers and closure system :- The choise for selection of the container closure system for the commercial product should be discussed . THe choise of the material for primary packaging and secondary packaging should be justified . A possible interaction between product and container or label should be considered .

10. Microbiological attributes :- The selection and effectiveness of preservative system is products containing antimicrobial preservative or the antimicrobial effectiveness of products that are inheretly atimicrobial . For sterile products , the integrity of the container closure system as it relates to preventing microbial contamination .

11. Compatibility :- The compatibility of the drug product with reconstitution diluents should be addressed to provide appropriate and supportive information for the labelling . This information should cover the recommended in use shelf life , at the recommended storage temperature and at the likely extremes of concentration .

12. Conclusion :- Concepts of QbD are ever growing need for better understanding of the formulation and process development by pharmaceutical scientists. Benefits of QbD application for both regulation agencies and manufacturing have been proven .

13. Reference :- Google.com Computer aided applications in pharmaceutical technology , by Jelena Djuris .

14. Thank You