ICH Q10 guideline.pptx

This topic is included in M.pharm
(Pharmaceutical quality assurance)
Sub name: quality management system
Semester: 1st
Unit: 2

1. QUALITY MANAGEMENT SYSTEM ICH Q 10 GUIDELINE (pharmaceutical quality system) Presented by: V. Aishwarya M pharm 1 st year ( pharmaceutical Quality Assurance) Annamalai university submitted to: Dr . K Devi ,M .pharm.., ph. D Assistant professor, Annamalai university 1

2. ICH Q10 GUIDELINE OUTLINE : 1) INTRODUCTION 2) PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM SCOPE RELATIONSHIP OF ICH Q10 TO REGIONAL GMP REQUIREMENT RELATIONSHIP OF ICH Q10 TO REGULATORY APPROACHES OBJECTIVES OF ICH Q10 ENABLERS DESIGN AND CONTENT CONSIDERATION QUALITY MANUAL 3) MANAGEMENT RESPONSIBILITIES 4) CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY LIFE CYCLE STAGE GOALS ELEMENTS OF PHARMACEUTICAL QUALITY SYSTEM 5) CONTINUAL IMPROVEMENT OF PHARMACEUTICAL QUALITY SYSTEM 2

3. 1) INTRODUCTION: ICH is the short form of “International council for harmonization” of technical requirements for registration of pharmaceuticals for human use. ICH Q10 ( pharmaceutical quality system) focus to encourage a paradigm shift from discrete GMP compliance procedures at every stage of the product lifecycle to a extensive quality systems approach over the lifecycle of the product. 3

4. ICH Q10 describing a model for an effective pharmaceutical quality management system for the pharmaceutical industry. ICH Q10 demonstrates industry and regulatory authorities support of an effective pharmaceutical quality system to enhance quality and availability of medicines around the world in the interest of public health. 4

5. The ICH is to measure international harmonization of technical requirements to ensure that safety, efficacy, high quality medicines are developed and registered in the most efficient and cost effective manner without breakage. This Photo by Unknown Author is licensed under CC BY-SA 5

6. It is a management system to direct and control a pharmaceutical company with regard to quality ICH is a joint initiative involving both regulators and research based industry representative of the EU, Japan and the US in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality, efficacy of the medicines. 6

7. It is based on three important aspects: 7

8. ICH Q10 PHARMACEUTICAL QUALITY SYSTEM MODEL 8

9. 2) SCOPE: Applicable to systems for development and manufacturing of APIs drug products biotechnology products. biological products throughout product lifecycle. There are 4 stages of guidelines. 9

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11. Pharmaceutical development: In the pharmaceutical development phase, the goal is to design products and plan the steps in manufacturing. Your organization will focus on meeting the needs of patients, caretakers, and healthcare professionals 11

12. The planning activities conducting phases a re: Developing drug substances Developing formulations, that include both container and closure systems Developing analytic methods Developing manufacturing processes and plans for the scale-up 12

13. Technology transfer : In the technology transfer phase, the goal is to transfer knowledge about both processes and products from the development phase to the manufacturing phase. The technical activities associated with this phase are: Transfer of products from development to manufacturing For marketed products, transfer between manufacturing and testing sites 13

14. With the help of Simpler QMS, you will avoid all paper trails and access unmatched quality process coverage. You will be able to easily track your documents between departments and facilities. 14

15. Commercial manufacturing: The goal of the commercial manufacturing phase of the ICH Q10 pharmaceutical quality system is to help your organization manufacture products through a process of continuous improvement . In this phase, the technical activities that your organization will perform are: Provide for facilities, equipment, and utilities packaging materials and labels Store, release, or distribute the manufactured products 15

16. The enhanced features of Simpler QMS will help you such as : D istribution of work instructions R eport generation E scalation of overdue activities 16

17. Product discontinuation: In this phase, your organization will supervise the end of a product’s lifecycle. The technical activities associated with this phase are: Management of document retention and sample retention Performing continuous product evaluation and reporting The Simpler QMS software helps your organization to track all your  QMS documentation , processes, protocols, and products. 17

18. Relationship of ICH Q10 to regional GMP requirement: ICH Q7 and ISO are the foundation of ICHQ 10 ICH Q10 is intended to be used together with GMP requirements. GMPs do not cover all stages of product. This guidance is aimed to promote continual improvement across the entire product lifecycle.. 18

19. Relationship of ICH Q10 to regulatory approaches: Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product, process understanding ,results of quality risk management , effectiveness of pharmaceutical quality system. When implemented the effectiveness of the pharmaceutical quality system can be normally evaluated during regulatory inspection at manufacturing site 19

20. OBJECTIVES OF ICH Q10: Implementation of the Q10 model in three main objectives : 20

21. Achieve product realization: To establish ,implement ,and maintain a system that allows the delivery of products with the quality attributes to meet the : needs of patients health care professionals regulatory authorities (including the compliance with approved regulatory filings) Other internal and external customers. 21

22. 2) Establish and maintain a state of control: To develop and use effective monitoring and control systems for process performance and product quality thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems. 22

23. 3)Facilitate continual improvement: To identify and implement appropriate : product quality improvements process improvements variability reduction innovations pharmaceutical quality system enhancements. Thereby increasing the ability to fulfil a pharmaceutical manufacturer own quality needs consistently. 23

24. Enablers : knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. Knowledge management Quality risk management 24

25. 1)knowledge management: Product and process knowledge should be managed from development through the commercial life of the product up and including product discontinuation. Knowledge management is a systematic approach to acquiring, analyzing, storing, disseminating information related to products, manufacturing processes and components. 25

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27. 2) Quality risk management(Q9); Quality risk management is integral to an effective pharmaceutical quality system It can provide a proactive approach to identifying, scientifically evaluating, controlling potential risk to quality. 27

28. Design and content consideration: The design, organization and documentation of the pharmaceutical quality system should be well structured and clear to facilitate common understanding. The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the different goals and knowledge available for each stage. 28

29. The size and complexity of the company’s activities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one. While some aspects of the pharmaceutical quality system can be company wide and others site specific, effectiveness of the pharmaceutical quality system is normally demonstrated at the site level. 29

30. Management responsibilities described in section 3 should be identified within the pharmaceutical quality system. The pharmaceutical quality system should include the following elements as described in section 4 Process performance and product quality monitoring Corrective and preventive action Change management Management review 30

31. QUALITY MANUAL: Quality manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system The description should include: The quality policy The scope of the pharmaceutical quality system Identification of the pharmaceutical quality system processes as well as their sequences ,linkage and interdependencies. Process maps and flow charts can be useful tools 31

32. What will a quality manual provide to a company? overall it provides evidence of what specific controls are implemented to ensure product /service quality. Who will benefit? Customers Suppliers Employees The company A quality manual should be: Address all quality system elements Contain or refer to quality procedures “documentation” Benefits of documentation quality manual: The key is to move towards: 1) consistently repeating the best practices 32

33. Basic quality manual outline : Introduction policy and objectives Definitions Quality system Organization Authority and responsibilities Compliance Internal review and audit Documentation and change Purchasing Inspection and testing training 33

34. 3) MANAGEMENT RESPONSIBILITY: Leadership is essential to establish and maintain a company wide commitment to quality and for the performance of the pharmaceutical quality system. Management commitment Quality policy Quality planning Resource management Internal communication Management review Outsourced activities Change to product ownership 34

35. Management commitment: senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives Roles responsibilities authorities are defined, communicated and implemented throughout the company Management should : Demonstrate strong and visible support. Ensure availability of timely and effective communication and escalation process. 35

36. Define role, responsibilities and authorities. Should participate in design, implementation, monitoring and maintenance. Ensure independent quality unit Conduct management reviews Advocate continual improvement Appropriate resources QUALITY POLICY: Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality. continual improvement. 36

37. Communicate at all levels Review is periodically for continuing effectiveness Quality planning: Defining and communicating quality objectives Quality objectives should align with strategies Should provide resource and training to achieve objectives Resource management: Determine and provide adequate and appropriate resources(human, financial, materials, facilities, equipment) Ensuring appropriate application of these resources 37

38. Internal communication: Management should ensure appropriate communication processes are established and implemented within the organisation. The process should ensure flow of correct information between the levels. Ensure appropriate and timely escalation of certain quality issues Management review: Conduct review to ensure suitability and effectiveness of PQS Asses the conclusion of process performance and product quality. 38

39. Control and outsourced activities and materials: Assess suitability of the materials. Establishing written agreements Monitoring and reviewing their performance Monitoring the incoming materials Change in product ownership: Transfer of essential information 39

40. 4) CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (life cycle stage goals) This section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements . Pharmaceutical development Technology transfer Commercial manufacturing Product discontinuation. 40

41. Pharmaceutical quality system elements: 41

42. Process performance and product quality monitoring system: Should use quality risk management approach for establishing control strategy. Includes parameters and attributes related to drug substance, input materials, facility and equipment operating conditions, in process control, finished product specification, methods and frequency of monitoring Provide tools for measurement of parameters 42

43. Analyses the parameters and attributes Identify source of variation Include feedback on product quality ( both internal and external) Provide knowledge to enhance process understanding design space and approach to process validation. 43

44. Corrective action and preventive action(CAPA) system: Should have system for implementing CAPA resulting from investigations of complaints , deviations , recalls, audits. Emphasis on root cause determination with structed approach Level of effort and formality be commensurate with level of the risk. 44

45. Change management system: Quality should be utilized to evaluate the change with efforts. Evaluate the change to regulatory filling. If working in design space it does not require regulatory filling update: Should be evaluated by expert teams( regulatory affairs) 45

46. Management review process: Follow up actions from previous review Should include results of regulatory inspection , audit finding commitment to authorities Review of complaint and recalls Conclusion of process performance and product quality Identify the improvements 46

47. 5) Continual improvement of pharmaceutical quality system: 47

48. Management review: Measure achievement of PQS objectives Assessment of performance indicators for effectiveness like: Complaint recall changes self assessment inspections. 48

49. Monitoring of internal and external factors: Quality issues that can impact the PQS Innovations that might enhance the PQS Change in product ownership Outcome of management review: Improvement to PQS and related processes Allocation and reallocation of resources Revision of quality policies and objectives Escalation of quality issues. 49

50. Reference: Text book of quality management system peeve( peevee book) ICH harmonised tripartite guideline. https://www.simplerqms.com/ich-q10-pharmaceutical-quality-system/ International conference on harmonization ICH Q10: pharmaceutical quality system ay 2007 / June 2008 Guidance for industry : quality system approach to pharmaceutical GMP regulations, September 2006 https://www.slideshare.net/mb3594/ich-q10-142747701 50

51. https://www.slideshare.net/ramu9682/ich-q10-pharmaceutical -quality-system-52729506 https://www.ema.Europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registeration-pharmaceuticals-human_en.pdf https://en.m.Wikipedia.org/wiki/international_council_for_harmonisation_of - technical-requirements-for-pharmaceuticals-for-human-use. https://database.ich.org/sites/default/files/Q10_presentation.pdf https://pubmed.ncbinim.nih.gov/34773177/ 51

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