Module 12 - part 1Slide 1 of 15 WHO - EDM Basic Principles of GMP Documentation Part 1 Part One, 14

Module 12 - part 1Slide 2 of 15 WHO - EDM Documentation Objectives 1. To review general requirements for documents 2. To review specific requirements for each document 3. To consider current issues applicable to your countries

Module 12 - part 1Slide 3 of 15 WHO - EDM Part One, 14 Documentation General Principles – I l Documentation is an essential part of QA and relates to all aspects of GMP l Purpose of documentation ä to ensure that there are specifications for all materials and methods of manufacture and control ä ensure all personnel know what to do and when to do it ä ensure that authorized persons have all information necessary for release ä provide audit trail

Module 12 - part 1Slide 4 of 15 WHO - EDM What is being made? Most of us when attempting a task need some sort of documentation Documentation

Module 12 - part 1Slide 5 of 15 WHO - EDM And if the drawing is wrong! Documentation

Module 12 - part 1Slide 6 of 15 WHO - EDM Why are documents so important? l Communication l Cost l Audit trail Documentation

Module 12 - part 1Slide 7 of 15 WHO - EDM Part One, 14 Documentation General Principles – I l Documents should be ä designed ä prepared ä reviewed ä distributed with care l Design of documentation

Module 12 - part 1Slide 8 of 15 WHO - EDM General Principles – II l Inspectors should look at the “Style” of the document ä Instructions in the imperative ä Short sentences ä Not long sentences Documentation

Module 12 - part 1Slide 9 of 15 WHO - EDM Part One, 14 Documentation General Principles – III l Approval of documentation ä Approved, signed and dated by appropriate authorized persons ä No document should be changed without authorization

Module 12 - part 1Slide 10 of 15 WHO - EDM Part One, 14 Documentation General Principles – IV l Distribution of documentation l Electronically or photographically recorded data

Module 12 - part 1Slide 11 of 15 WHO - EDM Part One, 14 Documentation General Principles – V l Review ä system for regular revision l Completion ä during the process

Module 12 - part 1Slide 12 of 15 WHO - EDM Part One, 14.10–14.49 Documentation Types of Documentation l Labels, specifications and master formulae l Batch processing and batch packaging records l Standard operating procedures l Stock control and distribution records l Water quality manual l Other types

Module 12 - part 1Slide 13 of 15 WHO - EDM Documentation

Module 12 - part 1Slide 14 of 15 WHO - EDM Documentation l Photographs can be documents and part of a herbal identification; provided they are properly authorised and controlled

Module 12 - part 1Slide 15 of 15 WHO - EDM Documentation l Flow charts provide substantial information at a glance