Basic Principles of GMP

2. Basic Principles of GMP Introduction to the Training Course

3. 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. 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. 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. 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. 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. Introduction Your Team Who are we? • Trainers  (Name)  (Qualifications)  (Experience)  (Name)  (Qualifications)  (Experience)

9. Introduction Who am I? • Name • Experience • Objectives • Not a lot of people know ………..

10. 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. 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. 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. 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. 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. 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. 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: SpecificMeasurableAction-orientedRealistic Time-related

17. 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