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 Continuous Improvement l Complaints and faults 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 – updates ä secure 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 Analytical records l Quality Control 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

16. WHO - PSM Headers and Footers l Header on all documents SOPs and Records etc.

17. WHO - PSM Laboratory Quality SystemAdmin 1.5.1. Quality Manual Amiable Laboratory Page 1 of 1 Issue No. Title of Section Issue Date 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 Person Head of Laboratory Issue Date Issue No. 3 Copy No. Holder Quality Manual Quality Manual - cover page A quality manual defines the quality system under which the laboratory operates

18. WHO - PSM Quality Manual - contents (1)

19. WHO - PSM Quality Manual - contents (2) -

20. WHO - PSM Quality Manual - contents (3)

21. WHO - PSM 1. Admin Audit reports System reviews Blank forms Memos Notices Quality Manual Record of anomalies Preventive actions 1.2.1.(index) General contract 2. Validation Fibre Milk Proficiency test 3. Equipment 3.01 Equip records 3.02 Operating procedures 3.2.1. balance 3.2.2. ovens 3.2.3. muffles 3.2.4. thermometers 3.2.5. pH meters List of General Procedures 4. Procedures 4.06 Quality control records 4.07 Reference standards 4.08 Result acceptability 4.09 Result reporting 4.10 Result uncertainties 4.11 Sample disposal 4.12 Sample reception 4.13 Sample registration 4.14 Staff records 4.15 System reviews 4.16 Training and competence 4.17 Recording and storing data 4.18 Document control 4.19 Out of Specification Report 4.01 Calibration records 4.02 Complaints and anomalies 4.03 Equipment records 4.04 Method validation 4.05 Quality audits 5. Quality Control 5.01 Fibre analysis 5.02 Milk analysis 5.03 Feed analysis 5.04 N by combustion 5.05 Q.C. limits 5.06 Test reports & log 6. Staff Records Job descriptions 7. Standard Methods ADF Dry matters Fat, protein & lactose in milk NDF Quality system files

22. WHO - PSM Electronic Documentation l Easier to upgrade ä Security ä access l Easier to distribute l Easier to ensure every one has latest version l Date entry problems ä Avoid transcription ä Palm pilots l Faster issuing of reports ä Authorised signature ä digital signatures

23. WHO - PSM Integrating Software ä Sample log ä Results entry ä Issuing Reports ä Online Access ä Issue of invoices ä Finance records (MYOB) ä Online access

24. WHO - PSM