m01[basic principles of gmp 1]

8/18/2019 m01[Basic Principles of GMP 1]

1/16

Module 1 Slide 1 of 16 WHO - EDM

Introduction

to the TrainingCourse

Basic Principles of GMP


2/16


Introduction

Objectives of this IntroductorySession

To outline the programme To introduce your trainers

To introduce you to one another and tounderstand your objectives and background

To understand the way these modules work


3/16


Introduction

Programme Overview – I

Basic Principles of !P

1. Introduction to the training programme

2. Quality Management

3. anitation and hygiene

!. "alidation

#. $omplaints and recalls


4/16


Introduction

Programme Overview – II


%. $ontract production and analysis

&. el' Inspection

(. )ersonnel

*. )remises

1+. ,-uipment


5/16


Introduction

Programme Overview – III


11. Materials

12. ocumentation

13. terile production

1!. /ctive pharmaceutical ingredients


6/16


Introduction

Programme Overview – I"

!P Inspection Process

1#. Introduction

1%. The role o' the inspector

1&. )reparation 'or the inspection

1(. Types o' 0M) inspection

1*. The inspection

2+. Trainers notes


7/16


Introduction

#our Team

$ho are we%

Trainers

(Name)

(Qualications)

(Experience)

(Name)

(Qualications) (Experience)


8/16


Introduction

$ho am I%

ame

,perience 4bjectives

ot a lot o' people know555..


9/16


Introduction

Objectives of the training course

To introduce general elements on -ualitymanagement

To train you in the 674 0M) tets 'or

pharmaceutical products

To bring in your own eperience

To develop your own action plan


10/16


Introduction

Our $ay of $or&ing

/ presentation on the subject o' the module 8usually no

more than %+ minutes

follows the W! text as the "asis of the module

will ha#e the W! reference at the "ottom of the

slide

/ 3+8%+ minutes group session discussing issues or

a problem that will be set 'or you 0roup 'eedback in plenary session

Multiple choice -ui9


11/16


Introduction

'ow the roup Session and (eedbac& wor&s Move to your area and select a group chairperson: a

timekeeper: a recorder and reporter to present thegroups views to the combined meeting

Identi'y the issues to be discussed. iscussion;

fundamental to the learnin$ process

need enthusiastic participation

needs a %"rainstormin$ approach&

ocument the groups views on 1


12/16


Introduction

$or&ing in roups

)lease accept shared responsibility in each group 'or;

ialogue

hared ideas

hared understanding

hared meaning

$lari'ying

)articipation

,nabling others toparticipate

/ctive listening

/greeing to disagree


13/16


Introduction

$or&ing in roups6hen someone says something which does not agreewith your views: 5.

or seems wrong to you.5

o not immediately say='hats wron$& or %ow stupid&

)ause> ?e


14/16


Introduction

roup Sessioniscuss the 0M) issues you each 'ace in your own

countries

Identi'y key objectives to be achieved in attending

this programme at; a ?egional level

ational level

4rganisational level

)ersonal level.


15/16


Introduction

roup Session Identi'y key objectives to be achieved in attending this

programme: at a ?egional level: at a ational level: at an4rganisation level and at a personal level.

et objectives using the S!)*T 'ormula;

SpeciBc !easurable )ction8oriented

*ealisticTime8related


16/16


Introduction

roup Session Identi'y key objectives to be achieved in attending this

programme: at a ?egional level: at a ational level: at an

4rganisation level and at a )ersonal level.

4bjectives should be developed in the S!)*T 'ormat;SpeciBc: !easurable: )ction8oriented: *ealistic: Time8related

Identi'y 3 success criteria by which the objective will be

measured.

)lease observe the times allowed; - hour maximum discussion . / -0 minutes maximum feed"ac, for each $roup

m01[basic principles of gmp 1]

Documents