Module 12 - part 1 Slide 1 of 15 WHO - EDM

Basic Principles of GMP

DocumentationPart 1

Part One, 14

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DocumentationObjectives

1. To review general requirements for documents

2. To review specific requirements for each document

3. To consider current issues applicable to your countries

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Part One, 14

Documentation General Principles – I

Documentation is an essential part of QA and relates to all aspects of GMP

Purpose of documentation to ensure that there are specifications for all

materials and methods of manufacture and control

ensure all personnel know what to do and when to do it

ensure that authorized persons have all information necessary for release

provide audit trail

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What is being made?Most of us

when attempting a task need some sort of documentation

Documentation

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And if the drawing is wrong!

Documentation

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Why are documents so important? Communication Cost Audit trail

Documentation

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Part One, 14

Documentation General Principles – I

Documents should be designed prepared reviewed distributed with care

Design of documentation

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General Principles – II Inspectors should look at the “Style” of the

document Instructions in the imperative Short sentences Not long sentences

Documentation

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Part One, 14

Documentation General Principles – III

Approval of documentation Approved, signed and dated by appropriate

authorized persons No document should be changed without

authorization

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Part One, 14

DocumentationGeneral Principles – IV

Distribution of documentation Electronically or photographically recorded

data

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Part One, 14

DocumentationGeneral Principles – V

Review system for regular revision

Completion during the process

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Part One, 14.10–14.49

DocumentationTypes of Documentation

Labels, specifications and master formulae Batch processing and batch packaging

records Standard operating procedures Stock control and distribution records Water quality manual Other types

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Documentation

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Documentation

Photographs can be documents and part of a herbal identification; provided they are properly authorised and controlled

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Documentation Flow charts provide substantial information at

a glance