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Basic Principles of GMP. Documentation - Part 1. Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm

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basic principles of gmp
Basic Principles of GMP

Documentation - Part 1

Workshop on

GMP and Quality Assurance of TB products

Kuala Lumpur

Malaysia, 21 – 25 February 2005

Maija Hietava

M.Sci.Pharm

Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster

Tel: +41.22.791.3598 Fax: +41.22.791.4730

World Health Organization

E-mail: hietavam@who.int

Part One, 15

documentation
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

documentation3
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

Part One,15

slide4

Documentation

What is being made?

Most of us when attempting a task need some sort of documentation

slide5

Documentation

And if the drawing is wrong!

documentation6
Documentation

Why are documents so important?

  • Communication
  • Cost
  • Audit trail:
    • "If it was not documented, it was not done"
documentation7
Documentation

General Principles – I

  • Documents should be
    • designed
    • prepared
    • reviewed
    • distributed with care
  • Design of documentation
    • every company has their own design

Part One,15

documentation8
Documentation

General Principles – II

  • Inspectors should look at the “Style” of the document
    • Instructions in the imperative
    • Short sentences
    • Not long sentences
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Documentation

General Principles – III

  • Approval of documentation
    • Approved, signed and dated by appropriate authorized persons
    • No document should be changed without authorization
      • CHANGE CONTROL
    • Alterations made to a document (batch record) should be signed and dated. Original information readable.

Part One,15

documentation10
Documentation

General Principles – IV

  • Distribution of documentation
    • Carefully controlled
    • Carefully controlled photocopying
    • SOP for details of performance
  • Electronically or photographically recorded data
    • pass words and authorised persons
    • Validations
    • Check of critical data by the system

Part One, 15

documentation11
Documentation

General Principles – V

  • Review
    • system for regular revision
    • SOPs are a "living" system
  • Completion
    • during the process – documentation in timely manner
    • Alterations – no corrective fluids!! But how??

Part One, 15

documentation12
Documentation

Question no 6

  • SOPs have to be reviewed regularly and there is always something to change, therefore SOPs is a “living” ??
documentation13
Documentation

Types 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

Part One, 15.10–15.48

documentation15
Documentation
  • Photographs can be documents and part of a herbal identification; provided they are properly authorised and controlled
documentation16
Documentation
  • Flow charts provide substantial information at a glance