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WHO - PSM
Basic Principles of GMP
Documentation - Part 1
Workshop onGMP and Quality Assurance of HIV products
Shanghai, China28 Feb - 4 March 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: +41.22.791.4730World Health Organization
E-mail: [email protected]
Part One, 15
WHO - PSM
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
WHO - PSM
Part One, 15
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
WHO - PSM
What is being made?
Most of us when attempting a task need some sort of documentation
Documentation
WHO - PSM
And if the drawing is wrong!
Documentation
WHO - PSM
Why are documents so important?
Communication
Cost
Audit trail:
"If it was not documented, it was not done"
Documentation
WHO - PSM
Part One, 15
Documentation
General Principles – I Documents should be
designed prepared reviewed distributed with care
Design of documentation every company has their own design
WHO - PSM
General Principles – II
Inspectors should look at the “Style” of the
document
Instructions in the imperative
Short sentences
Not long sentences
Documentation
WHO - PSM
Part One, 15
Documentation
General Principles – III
Approval of documentation Approved, signed and dated by appropriate
authorized persons No document should be changed without
authorizationCHANGE CONTROL
Alterations made to a document (batch record) should be signed and dated. Original information readable.
WHO - PSM
Part One, 15
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
WHO - PSM
Part One, 15
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??
WHO - PSM
Part One, 15.10–15.48
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
WHO - PSM
Documentation
WHO - PSM
Documentation
Photographs can be documents and part of a herbal identification; provided they are properly authorised and controlled
WHO - PSM
Documentation Flow charts provide substantial information at
a glance
