1. QP QMSDocumentation Systems Documentation Systems

2. QP QMSDocumentation Systems Major Non conformances in UK (per the MHRA) From 1999 to 2007 Documentation non conformances were always in Top 10

3. QP QMSDocumentation Systems

4. QP QMSDocumentation Systems EU Scope Drug Substance (via EDQM) Drug Product (via National Agencies) Legislation in place Guidance also (EU GMP Volume 4 Part 1 and 2) Plus Annexes

5. QP QMSDocumentation Systems 1 4 Guidance EU GMP Volume 4 Part 1 What does it call for regarding Documentation Systems? Referred to in Section 1 Also There is a full section on Documentation Systems Section 4

6. QP QMSDocumentation Systems 1 Guidance EU GMP Volume 4 Part 1 Referred to in Section 1 • Organised arrangements ... • Operations are clearly specified ... • Responsibilities are clearly specified ... • There is a procedure for ... • ... Are clearly defined ... • ... Procedures are written ... • ... Records are made ...

7. QP QMSDocumentation Systems 4 Guidance EU GMP Volume 4 Part 1 There is a full section on Documentation Systems Lists the various categories of documents • Specifications • Production Instructions • Procedures • Records

8. QP QMSDocumentation Systems 4 GDP Guidance EU GMP Volume 4 Part 1 There is a full section on Documentation Systems Lists the various attributes of documents • Handled with care • Approved • Clear and unambiguous • Kept up to date • Not hand-written • No cross outs • Real time recording • Archived

9. QP QMSDocumentation Systems 4 Guidance EU GMP Volume 4 Part 1 Distribution Available at point of use

10. QP QMSDocumentation Systems 4 Guidance EU GMP Volume 4 Part 1 Change Control Critical part of managing the system throughout its life cycle Very strict internal rules required Summaries are very useful Diligent archiving of change control documents

11. QP QMSDocumentation Systems 4 Guidance EU GMP Volume 4 Part 1 Electronic format requirements as follows: Proceduralised Verify accuracy Restricted access Under change control Backed up Readily available

12. QP QMSDocumentation Systems Guidance EU GMP Volume 4 Part 1 Documents Required Specifications for Starting materials Packaging materials Intermediates Bulk products Finished products 4

13. QP QMSDocumentation Systems Guidance EU GMP Volume 4 Part 1 Documents Required (continued) Manufacturing formulae Processing instructions Packaging instructions Batch processing records Batch packaging records Receipt records Sampling records Testing records Release procedures Rejection procedures Distribution records Log books 4

14. QP QMSDocumentation Systems Guidance EU GMP Volume 4 Part 1 Documents Required (continued) Validation Equipment calibration Cleaning Maintenance Training Sanitation Environmental monitoring Pest control Complaints Recalls Returns 4

15. QP QMSDocumentation Systems Guidance EU GMP Volume 4 Part 1 Documents Archiving and Retention GMP Shelf Life plus one year GDP 5 Years Recommend make electronic copies, easily kept forever 4