Basic Principles of GMP

1
Basic Principles of GMP

• Documentation - Part 1

Workshop on GMP and Quality Assurance of HIV
products Shanghai, China 28 Feb - 4 March 2005
Maija Hietava M.Sci.Pharm Quality Assurance
and Safety Medicines, Medicines Policy and
Standards, Health Technology and Pharmaceuticals
Cluster Tel [phone] Fax
41.22.791.4730 World Health Organization E-mail
hietavam_at_who.int
Part One, 15
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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

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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
4
Documentation
What is being made?
Most of us when attempting a task need some sort
of documentation
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Documentation
And if the drawing is wrong!
6
Documentation

• Why are documents so important?
• Communication
• Continuous Improvement
• Complaints and faults
• Cost
• Audit trail
• "If it was not documented, it was not done"

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Documentation

• General Principles I
• Documents should be
• designed
• prepared
• reviewed
• distributed with care
• updates
• secure
• Design of documentation
• every company has their own design

Part One, 15
8
Documentation

• General Principles II
• Inspectors should look at the Style of the
  document
• Instructions in the imperative
• Short sentences
• Not long sentences

9
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
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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
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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
12
Documentation

• Types of Documentation
• Labels, specifications and master formulae
• Batch processing and batch packaging records
• Standard operating procedures
• Stock control and distribution records
• Analytical records
• Quality Control Records
• Water quality manual
• Other types

Part One, 15.1015.48
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Documentation
14
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

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Headers and Footers

• Header on all documents SOPs and Records etc.

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QualityManual

Laboratory Quality System
Admin 1.5.1.
Quality Manual


Page 1 of 1
Amiable Laboratory


Issue No.



Issue Date
Title of Section


Title Page


Issued by




QUALITY MANUAL

for


Amiable Laboratory


Benevolent Department


Well-intentioned Organisation


Usual Location





This Manual is issued under the authority of
A quality manual defines the quality system
under which the laboratory operates








Issue Date

..................................................
..........



Issue No.

3


A Person

Copy No.





Holder
Head of Laboratory







Quality Manual - cover page
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QualityManual - contents (1)

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QualityManual - contents (2)
-
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QualityManual - contents (3)

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Quality system files
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Electronic Documentation

• Easier to upgrade
• Security
• access
• Easier to distribute
• Easier to ensure every one has latest version
• Date entry problems
• Avoid transcription
• Palm pilots
• Faster issuing of reports
• Authorised signature
• digital signatures

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Integrating Software

• Sample log
• Results entry
• Issuing Reports
• Online Access
• Issue of invoices
• Finance records (MYOB)
• Online access

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The End