October 22, 2016

Basic Principles of GMP

Introduction
to the Training Course

Module 1
2006

Slide 2 of 17

January

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

Module 1
2006

Slide 3 of 17

January

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

Module 1
2006

Slide 4 of 17

January

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

Module 1
2006

Slide 5 of 17

January

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

Module 1
2006

Slide 6 of 17

January

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

Module 1
2006

Slide 7 of 17

January

Introduction
Your Team
Who are we?
Trainers
(Name)
(Qualifications)
(Experience)
(Name)
(Qualifications)
(Experience)

Module 1
2006

Slide 8 of 17

January

Introduction
Who am I?

Name
Experience
Objectives
Not a lot of people know ..

Module 1
2006

Slide 9 of 17

January

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

Module 1
2006

Slide 10 of 17

January

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
Module 1
2006

Slide 11 of 17

January

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 groups 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 groups views on 1 flip-chart page
Maximum of 10 minutes for each groups presentation

Module 1
2006

Slide 12 of 17

January

Introduction
Working in Groups
Please accept shared responsibility in each group for:
Dialogue

Participation

Shared ideas
Shared understanding

Enabling others to
participate

Shared meaning

Active listening

Clarifying

Agreeing to disagree

Module 1
2006

Slide 13 of 17

January

Introduction
Working in Groups
When someone says something which does not agree with your
or seems wrong to you .
Do not immediately say
Thats wrong or How stupid
Pause; Reflect
What do they really mean?
Say instead
An interesting idea or
thats a different way of looking at it

Module 1
2006

Slide 14 of 17

January

views .

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

Module 1
2006

Slide 15 of 17

January

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

Module 1
2006

Slide 16 of 17

January

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
Module 1
2006

Slide 17 of 17

January