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: +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 • Continuous Improvement • Complaints and faults • 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 • 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

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 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, 15.10–15.48

13. Documentation

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

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

16. Headers and Footers • Header on all documents SOPs and Records etc.

17. QualityManual Laboratory Quality System Quality Manual Admin 1.5.1. 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 A quality manual defines the quality system under which the laboratory operates This Manual is issued under the authority of Issue Date ............................................................ Issue No. 3 A Person Copy No. Holder Head of Laboratory Quality Manual - cover page

18. QualityManual - contents (1)

19. QualityManual - contents (2) -

20. QualityManual - contents (3)

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

22. 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

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

24. The End