1. WHO - PSM 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: +41.22.791.3598 Fax: +41.22.791.4730 World Health Organization E-mail: hietavam@who.int Part One, 15

2. 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

3. WHO - PSM Part One, 15 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

4. WHO - PSM What is being made? Most of us when attempting a task need some sort of documentation Documentation

5. WHO - PSM And if the drawing is wrong! Documentation

6. WHO - PSM Why are documents so important? l Communication l Cost l Audit trail: ä "If it was not documented, it was not done" Documentation

7. WHO - PSM Part One, 15 Documentation General Principles – I l Documents should be ä designed ä prepared ä reviewed ä distributed with care l Design of documentation ä every company has their own design

8. WHO - PSM 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

9. WHO - PSM Part One, 15 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  CHANGE CONTROL ä Alterations made to a document (batch record) should be signed and dated. Original information readable.

10. WHO - PSM Part One, 15 Documentation General Principles – IV l Distribution of documentation ä Carefully controlled ä Carefully controlled photocopying ä SOP for details of performance l Electronically or photographically recorded data ä pass words and authorised persons ä Validations ä Check of critical data by the system

11. WHO - PSM Part One, 15 Documentation General Principles – V l Review ä system for regular revision ä SOPs are a "living" system l Completion ä during the process – documentation in timely manner ä Alterations – no corrective fluids!! But how??

12. WHO - PSM Part One, 15.10–15.48 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

13. WHO - PSM Documentation

14. WHO - PSM Documentation l Photographs can be documents and part of a herbal identification; provided they are properly authorised and controlled

15. WHO - PSM Documentation l Flow charts provide substantial information at a glance