ICH Q10 GUIDELINES.pptx

ICH Q10 GUIDELINES (PHARMACEUTICAL QUALITY SYSTEM)
- Contents
- ICH
- ICH GUIDELINES
- Objective
Q10 GUIDELINE
- Introduction
- Scope
- Objective of Q10 Guideline
- Elements
- CAPA System
- Change Management System
- Continual improvement of pharmaceutical quality system
- References
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1. ICH Q10: PHARMACEUTICAL QUALITY SYSTEM

2. TABLE OF CONTENTS ICH ICH guideline Objective of ICH guideline Introduction of ICH Q10 Scope Objective of ICH Q10 Element of pharmaceutical quality system Continual improvement of pharma Reference 2

3. ICH ICH stands for INTERNATIONAL COUNCIL FOR HARMONISATION of Technical Requirement for Pharmaceuticals for Human Use. Head quarter: Geneva The meeting of ICH are lead twice in the year. Members of ICH: Japan, Europe and USA 3

4. ICH GUIDELINE 4

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8. Objective of ICH To increase international harmonization of technical requirements to ensure that safe, effective and high quality medicines are developed. To harmonize technical requirements for registration or marketing approval. To develop and register pharmaceuticals in the most efficient and cost effective manner. To promote public health. 8

9. ICH Q10: PHARMACEUTICAL QUALITY SYSTEM 9

10. Introduction ICH Q10 pharmaceutical quality system guidelines are a model for the effective quality management system for organizations in the pharmaceutical industry. These guidelines are based on ISO quality concepts and incorporate regional GMP regulations. ICH Q10 was adopted in the year 2008 to established and implement an effective QA system in order to comply with GMP. 10

11. Scope This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology and biological products, throughout the product lifecycle. 11

12. Scope For the purposes of this guideline, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation 12

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14. OBJECTIVE OF Q10 GUIDELINE  The Q10 model have three main objectives that enhance regional GMP requirements: 14

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16. Relationship of ICH Q10 to Regional GMP Requirements The regional GMPs do not explicitly address all stages of the product lifecycle (e.g., development). The quality system elements and management responsibilities described in this guidance are intended to encourage the use of science- and risk-based approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle. 16

17. Relationship of ICH Q10 to Regulatory Approaches Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and process understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system. When implemented, the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site. 17

18. Knowledge Management and Quality Risk Management Knowledge Management Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. Knowledge management is a systematic approach to acquiring, analyzing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include, pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities. 18

19. Continue.. 2. Quality Risk Management Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. 19

20. Pharmaceutical Quality System Elements 20

21. Process Performance and Product Quality Monitoring System Use quality risk management to establish the control strategy. This can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in process controls, finished product specifications, and the associated methods and frequency of monitoring and control. Provide the tools for measurement and analysis of parameters. Identify sources of variation affecting process performance and product. 21

22. Corrective Action and Preventive Action (CAPA) System The pharmaceutical company should have a system for implementing corrective actions and preventive actions resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. A structured approach to the investigation process should be used with the objective of determining the root cause. 22

23. Change Management System Quality risk management should be utilized to evaluate proposed changes. The level of effort and formality of the evaluation should be commensurate with the level of risk. Proposed changes should be evaluated relative to the marketing authorization, including design space, where established, and/or current product and process understanding Proposed changes should be evaluated by expert teams contributing the appropriate expertise and knowledge from relevant areas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulatory Affairs and Medical), to ensure the change is technically justified. Prospective evaluation criteria for a proposed change should be set. 23

24. Management Review of Process Performance and Product Quality Management review should provide assurance that process performance and product quality are managed over the lifecycle. Depending on the size and complexity of the company, management review can be a series of reviews at various levels of management and should include a timely and effective communication and escalation process to raise appropriate quality issues to senior levels of management for review. 24

25. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM This section describes activities that should be conducted to manage and continually improve the pharmaceutical quality system . 25 A B C

26. A. Management Review of the Pharmaceutical Quality System Management should have a formal process for reviewing the pharmaceutical quality system on a periodic basis. The review should include: Measurement of achievement of pharmaceutical quality system objectives Assessment of performance indicators that can be used to monitor the effectiveness of processes within the pharmaceutical quality system, such as Complaint, deviation, CAPA and change management processe Feedback on outsourced activities 26

27. B. Monitoring of internal and external factors impacting the pharmaceutical quality system Factors monitored by management can include: Emerging regulations, guidance and quality issues that can impact the Pharmaceutical Quality System; Innovations that might enhance the pharmaceutical quality system; Changes in business environment and objectives; Changes in product ownership. 27

28. C. Outcomes of Management Review and Monitoring The outcome of management review of the pharmaceutical quality system and monitoring include: Improvements to the pharmaceutical quality system and related processes; Allocation or reallocation of resources and/or personnel training; Revisions to quality policy and quality objectives; Documentation, timely and effective communication of the results of the management review and actions, including escalation of appropriate issues to senior management. 28

29. 29 note on ICH guideline Q10: - ICH guideline Q10, also known as the "Pharmaceutical Quality System," is a regulatory guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guideline provides recommendations for the implementation of a pharmaceutical quality system (PQS) to ensure that drug products are consistently of high quality. The PQS is a comprehensive system that includes all aspects of the pharmaceutical development and manufacturing process, from product design and development to manufacturing, testing, and post-marketing activities. The PQS is designed to ensure that all processes are clearly defined, documented, and controlled, and that any deviations from established procedures are promptly identified and corrected. The ICH Q10 guideline provides a framework for the development, implementation, and maintenance of a PQS, and includes recommendations on the management of quality systems, the management of outsourced activities, the management of change, and the management of risk. The guideline emphasizes the importance of a continuous improvement approach to quality management, and recommends the use of quality metrics to monitor and evaluate the performance of the PQS. The guideline also emphasizes the importance of a company-wide culture of quality, which involves the active participation of all employees in the development and implementation of the PQS. Overall, the ICH Q10 guideline provides a comprehensive framework for the implementation of a PQS to ensure that drug products are consistently of high quality. Compliance with the guideline is essential for the approval and registration of new drugs in many regulatory jurisdictions around the world, and can also lead to improved efficiency, productivity, and cost-effectiveness in the pharmaceutical industry.

30. Reference https://www.ich.org/page/ich-guidelines https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human_en.pdf 30

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