Basic Principles of GMP- 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