WHO GMP- Introduction to the Training Course-1
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This document outlines an introductory training course on basic principles of Good Manufacturing Practice (GMP). The course objectives are to introduce elements of quality management and train participants in WHO GMP texts. It will cover topics like quality management, sanitation, and sterile production over several modules. Participants will work in groups to discuss issues, set objectives for attending, and provide feedback. The goals are for participants to bring experience, develop action plans, and gain a shared understanding of GMP principles.
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WHO GMP- Introduction to the Training Course-1
- 1. 6 April 2022
- 2. Module 1 | Slide 2 of 17 January 2006 Basic Principles of GMP Introduction to the Training Course
- 3. Module 1 | Slide 3 of 17 January 2006 Introduction Objectives of this Introductory Session To outline the programme To introduce your trainers To introduce you to one another and to understand your objectives and background To understand the way these modules work
- 4. Module 1 | Slide 4 of 17 January 2006 Introduction Programme Overview – I Basic Principles of GMP WHO Technical Report Series, No. 908, 2003, Annex 4 1. Introduction to the training programme 2. Quality Management 3. Sanitation and hygiene 4. Qualification and Validation 5. Complaints and recalls
- 5. Module 1 | Slide 5 of 17 January 2006 Introduction Programme Overview – II Basic Principles of GMP 6. Contract production and analysis 7. Self Inspection and quality audits 8. Personnel 9. Premises 10. Equipment
- 6. Module 1 | Slide 6 of 17 January 2006 Introduction Programme Overview – III Basic Principles of GMP 11. Materials 12. Documentation 13. Good Practices in production and quality control 14. Sterile production 15. Active pharmaceutical ingredients
- 7. Module 1 | Slide 7 of 17 January 2006 Introduction Programme Overview – IV GMP Inspection Process 16. Introduction 17. The role of the inspector 18. Preparation for the inspection 19. Types of GMP inspection 20. The inspection Trainers’ notes
- 8. Module 1 | Slide 8 of 17 January 2006 Introduction Your Team Who are we? Trainers (Name) (Qualifications) (Experience) (Name) (Qualifications) (Experience)
- 9. Module 1 | Slide 9 of 17 January 2006 Introduction Who am I? Name Experience Objectives Not a lot of people know ………..
- 10. Module 1 | Slide 10 of 17 January 2006 Introduction Objectives of the training course To introduce general elements on quality management To train you in the WHO GMP texts for pharmaceutical products To bring in your own experience To develop your own action plan
- 11. Module 1 | Slide 11 of 17 January 2006 Introduction Our Way of Working A presentation on the subject of the module - usually about 60 minutes follows the WHO text as the basis of the module will have the WHO reference at the bottom of the slide A 30-60 minute group session discussing issues or a problem that will be set for you Group feedback in plenary session Multiple choice quiz
- 12. Module 1 | Slide 12 of 17 January 2006 Introduction How the Group Session and Feedback works Move to your area and select a group chairperson, a timekeeper, a recorder and reporter to present the group’s views to the combined meeting Identify the issues to be discussed Discussion: fundamental to the learning process needs enthusiastic participation needs a “brainstorming approach” Document the group’s views on 1 flip-chart page Maximum of 10 minutes for each group’s presentation
- 13. Module 1 | Slide 13 of 17 January 2006 Introduction Working in Groups Please accept shared responsibility in each group for: Dialogue Shared ideas Shared understanding Shared meaning Clarifying Participation Enabling others to participate Active listening Agreeing to disagree
- 14. Module 1 | Slide 14 of 17 January 2006 Introduction Working in Groups When someone says something which does not agree with your views …. or seems wrong to you .… Do not immediately say “That’s wrong” or “How stupid” Pause; Reflect “What do they really mean?” Say instead “An interesting idea” or “that’s a different way of looking at it”
- 15. Module 1 | Slide 15 of 17 January 2006 Introduction Group Session Discuss the GMP issues you each face in your own countries Identify key objectives to be achieved in attending this programme at a: Regional level National level Organizational level Personal level
- 16. Module 1 | Slide 16 of 17 January 2006 Introduction Group Session Identify key objectives to be achieved in attending this programme, at a Regional level, at a National level, at an Organizational level and at a Personal level. Set objectives using the SMART formula: Specific Measurable Action-oriented Realistic Time-related
- 17. Module 1 | Slide 17 of 17 January 2006 Introduction Group Session Identify key objectives to be achieved in attending this programme, at a Regional level, at a National level, at an Organizational level and at a Personal level. Objectives should be developed in the SMART format: Specific, Measurable, Action-oriented, Realistic, Time-related Identify 3 success criteria by which the objective will be measured. Please observe the times allowed: 1 hour maximum discussion 5 - 10 minutes maximum feedback for each group