Developing specifications in ICH Q6B guidelines.

Developing specifications on ICH Q6B guidelines.

1. Developing specifications of ICH Q6B guideline SUBMITTED TO SAVITRIBAI PHULE, PUNE UNIVERSITY, PUNE FOR PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF DEGREE OF MASTER OF PHARMACY IN PHARMACEUTICAL QUALITY ASSURANCE IN THE FACULTY OF SCIENCE AND TECHNOLOGY Bhujbal Knowledge City, MET’s Institute of Pharmacy, Adgaon , Nashik, 422003. Maharashtra, India Academic Year - 2025-2026 Presented By Ankita Rathod M.Pharm Sem -I Guided By Dr. Gitanjali S. Deokar Head, Department of Quality Assurance

2. Introduction to ICH Q6B ICH (International Council for Harmonisation ) Guidelines are global standards. ICH Q6B specifically focuses on the specifications for biological products. Defines the framework for establishing and evaluating product specifications. What is ICH Q6B? ICH Q6B provides guidelines for setting specifications for the quality control of biological products. It ensures that biopharmaceuticals meet quality standards, are safe, and perform effectively.

3. Importance of ICH Q6B Ensures the consistency and reliability of biopharmaceutical products. Facilitates international trade of pharmaceutical products. Protects patient health by maintaining quality standards. Scope of ICH Q6B Applicable to all biological products including vaccines, proteins, monoclonal antibodies, etc. Focuses on product development, manufacturing processes, and stability.

4. Key Elements of Specifications in ICH Q6B Identity Purity Potency Stability Sterility

5. Setting Specifications: Key Considerations Product characteristics and intended use. Analytical techniques and methods available. Stability and shelf-life data. Risk management. Biological Product Specifications: Types Primary Specifications: Assures identity, purity, and potency. Secondary Specifications: Assures attributes related to performance and stability.

6. Types of Tests in ICH Q6B Chemical tests: Determine the content and composition of active ingredients. Biological tests: Ensure the biological activity and potency. Microbiological tests: Check for contamination or microbial load. The Role of Stability Data in Specifications Establishes the shelf life of a product. Ensures continued potency and safety throughout the product's lifecycle.

7. Risk Assessment Matrix A visual representation of the risk assessment process. X-axis: Probability of failure; Y-axis: Impact on patient safety. Purpose: To show how risk is assessed when developing specifications for biological products. Content: This chart will display a matrix with two axes: Probability of occurrence on the X-axis (Low, Medium, High) and Impact on patient safety on the Y-axis (Low, Medium, High). The matrix can color code the areas to indicate the level of risk (e.g.,

8. Low risk = green, Medium risk = yellow, High risk = red). Example: Low Impact Medium Impact High Impact Low Probability Green (Low Risk) Yellow (Moderate Risk) Red (High Risk) Medium Probability Yellow (Moderate Risk) Orange (High Risk) Red (High Risk) High Probability Yellow (Moderate Risk) Orange (High Risk) Red (High Risk)

9. Establishing Limits and Acceptance Criteria Defines acceptable ranges for each attribute. Based on historical data, clinical experience, and stability studies. Regulatory Considerations for Specifications Regulatory bodies require documented evidence of specification testing. Compliance with global regulatory standards (FDA, EMA, etc.) is necessary. Example of Acceptance Criteria for Potency A bar graph or table showing acceptable limits for potency based on different tests or time points.

10. Acceptance Criteria for Potency Purpose: To show the acceptable ranges or limits for potency testing based on ICH Q6B specifications. Content: A bar chart comparing different potency testing results over time or across different batches, highlighting which values fall within the acceptable range. Example: X-axis: Time points or batches. Y-axis: Potency values. A horizontal line showing the acceptance limit range.

11. Example: Time Points/Batches: Batch 1, Batch 2, Batch 3, Batch 4, Batch 5 Acceptance Limits: 90% – 110% potency range Batch Potency (%) Status Batch 1 95% Within Range Batch 2 88% Below Range Batch 3 102% Within Range Batch 4 115% Above Range Batch 5 98% Within Range

12. Challenges in Developing Specifications Variability in biological systems. Difficulty in defining acceptance limits for complex products. Balancing flexibility with strict quality control. Quality Control in Manufacturing In-process testing to ensure specifications are met during production. Continuous monitoring and quality audits.

13. Future Trends in ICH Q6B Specification Development Increased use of advanced analytical technologies (e.g., bioanalytics ). Personalized medicine and biologics complexity. Global harmonization of standards. Conclusion: ICH Q6B provides essential guidelines for ensuring the quality and safety of biological products. Robust specification development is a cornerstone of pharmaceutical manufacturing.

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