1. 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

2. 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. 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

5. Documentation And if the drawing is wrong!

6. Documentation Why are documents so important? • Communication • Cost • Audit trail: • "If it was not documented, it was not done"

7. 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

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

10. 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

11. 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 Question no 6 • SOPs have to be reviewed regularly and there is always something to change, therefore SOPs is a “living” ??

13. 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

14. Documentation

15. Documentation • Photographs can be documents and part of a herbal identification; provided they are properly authorised and controlled

16. Documentation • Flow charts provide substantial information at a glance