1. Module 12 – part 1 | Slide 1 of 20 January 2006 Basic Principles of GMP Documentation Part 1 15

2. Module 12 – part 1 | Slide 2 of 20 January 2006 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. Module 12 – part 1 | Slide 3 of 20 January 2006 15.1 Documentation General Principles – I Good documentation is an essential part of the QA system Should exist for all aspects of GMP Purpose of documentation äDefines specifications and procedures for all materials and methods of manufacture and control äEnsures all personnel know what to do and when to do it äEnsure that authorized persons have all information necessary for release of product

4. Module 12 – part 1 | Slide 4 of 20 January 2006 15.1 Documentation General Principles – I Purpose of documentation (cont.) äEnsures documented evidence, traceability, provide records and audit trail for investigation äEnsures availability of data for validation, review and statistical analysis Design and use äDepends upon manufacturer äSome documents combined into one, sometimes separate

5. Module 12 – part 1 | Slide 5 of 20 January 2006 What is being made? Most of us when attempting a task need some sort of documentation Documentation

6. Module 12 – part 1 | Slide 6 of 20 January 2006 And if the drawing is wrong! Documentation

7. Module 12 – part 1 | Slide 7 of 20 January 2006 Documentation

8. Module 12 – part 1 | Slide 8 of 20 January 2006 Why are documents so important? Communication Cost Audit trail Documentation

9. Module 12 – part 1 | Slide 9 of 20 January 2006 15.2 Documentation General Principles – I Documents should be ädesigned äprepared äreviewed ädistributed with care Comply with marketing authorization Design of documentation important

10. Module 12 – part 1 | Slide 10 of 20 January 2006 General Principles – II Look at the “Style” of the document äInstructions in the imperative äShort sentences preferred to long sentences Approval of documentation äApproved, signed and dated by appropriate responsible persons äNo document should be changed without authorization and approval Documentation 15.3

11. Module 12 – part 1 | Slide 11 of 20 January 2006 15.4 Documentation General Principles – III Contents of documents should be clear (easy to understand) and include, e.g. äTitle, nature, objective or purpose Layout in orderly fashion Easy to be filled in and checked Clear and readable – including copies made No errors if master documents are copied for working documents

12. Module 12 – part 1 | Slide 12 of 20 January 2006 15.5 Documentation General Principles – IV Documentation control Regular review of documents Kept up to date (current) - amended Superseded documents removed and not used äDistribution and retrieval of documentation Retention time for superseded documents

13. Module 12 – part 1 | Slide 13 of 20 January 2006 15.6 – 15.8 Documentation General Principles – V Data entry Clear, readable and indelible Design to allow for sufficient space for entries Changes to entries: äsigned, dated and reason given äoriginal entry still readable Entries at the time of action All significant actions recorded – traceable

14. Module 12 – part 1 | Slide 14 of 20 January 2006 15.9 Documentation General Principles – VI Data entry (cont.) Electronic data processing systems, photographic systems or other reliable means Systems require SOPs and records Accuracy of records checked Authorized persons - access and changes Password controlled Entries checked

15. Module 12 – part 1 | Slide 15 of 20 January 2006 15.9 Documentation General Principles – VII Data entry (cont.) Batch records stored electronically: äProtected äBack-up transfer, e.g. magnetic tape, microfilm, paper print-outs Records kept 1 year after expiry date of product Data readily available during retention period

16. Module 12 – part 1 | Slide 16 of 20 January 2006 Documentation Types of Documentation Labels Specifications and testing procedures Master formulae and instructions Batch processing and batch packaging records Standard Operating Procedures (SOPs) Records äStock control and distribution records Other documents …

17. Module 12 – part 1 | Slide 17 of 20 January 2006 Documentation

18. Module 12 – part 1 | Slide 18 of 20 January 2006 Documentation Photographs can be documents and part of a herbal identification, provided they are properly authorized and controlled

19. Module 12 – part 1 | Slide 19 of 20 January 2006 Documentation Flow charts provide substantial information at a glance

20. Module 12 – part 1 | Slide 20 of 20 January 2006 Documentation Types of Documentation The different types of documents will be discussed in detail in Documentation: Part 2