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Basic Principles of GMP

Introduction
to the Training
Course

Module 1

Slide 1 of 16

WHO - EDM

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

Module 1

understand the way these modules work

Slide 2 of 16

WHO - EDM

Introduction
Programme Overview I

Basic Principles of GMP


1.

Introduction to the training programme

2.

Quality Management

3.

Sanitation and hygiene

4.

Validation

5.

Complaints and recalls

Module 1

Slide 3 of 16

WHO - EDM

Introduction
Programme Overview II

Basic Principles of GMP


6. Contract production and analysis
7. Self Inspection
8. Personnel
9. Premises
10. Equipment

Module 1

Slide 4 of 16

WHO - EDM

Introduction
Programme Overview III

Basic Principles of GMP


11. Materials
12. Documentation
13. Sterile production
14. Active pharmaceutical ingredients

Module 1

Slide 5 of 16

WHO - EDM

Introduction
Programme Overview IV

GMP Inspection Process


15.

Introduction

16.

The role of the inspector

17.

Preparation for the inspection

18.

Types of GMP inspection

19.

The inspection

20.

Trainers notes

Module 1

Slide 6 of 16

WHO - EDM

Introduction
Your Team
Who are we?

Trainers
(Name)
(Qualifications)
(Experience)
(Name)
(Qualifications)
(Experience)

Module 1

Slide 7 of 16

WHO - EDM

Introduction
Who am I?

Name

Experience

Objectives

Not a lot of people know..

Module 1

Slide 8 of 16

WHO - EDM

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

Slide 9 of 16

WHO - EDM

Introduction
Our Way of Working
A presentation on the subject of the module usually no
more than 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 minutes group session discussing issues or


a
problem that will be set for you

Group feedback in plenary session


Multiple choice quiz

Module 1

Slide 10 of 16

WHO - EDM

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
need 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

Slide 11 of 16

WHO - EDM

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

Dialogue

Participation

Shared ideas

Shared understanding

Enabling others to
participate

Active listening

Agreeing to disagree

Module 1

Shared meaning
Clarifying

Slide 12 of 16

WHO - EDM

Introduction
Working in Groups
When someone says something which does not agree
with your views, .
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

Slide 13 of 16

WHO - EDM

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

Organisational level

Personal level.

Module 1

Slide 14 of 16

WHO - EDM

Introduction
Group Session

Identify key objectives to be achieved in attending this


programme, at a Regional level, at a National level, at an
Organisation level and at a personal level.

Set objectives using the SMART formula:


Specific
Measurable
Action-oriented
Realistic
Time-related

Module 1

Slide 15 of 16

WHO - EDM

Introduction
Group Session

Identify key objectives to be achieved in attending this


programme, at a Regional level, at a National level, at an
Organisation 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

Slide 16 of 16

WHO - EDM