1. MHRA Inspection Readiness By Lulu Cvetkovic NICR QA Manager

3. Expect notification

4. First of all DO NOT

5. What you should do is…

6. What you need

7. Go back to basics  Start to plan as soon as possible  Assign actions and responsibilities to staff  Make sure that people know what to say and do  Know your systems  Know your weaknesses  Self inspections  Mock inspections  Talk to management about any concerns

8. Review the obvious  Training records  Change control  Equipment maintenance/calibration  Temperature control  Impact assessments  Document control  Look at previous findings  Make sure that labs are tidy and clean

9. Get everyone involved

10. People Matter  Communicate at all levels  Consider who will act as a guide and who will act as a host for each department  Need ‘gofers’  Someone to act as a scribe  Training or re training on auditee behaviour and knowledge

11. The ideal Auditee  Answer the question – no more and no less  Provide any records requested – no more and no less  Be prepared to justify your reasoning – without coming across as aggressive or defensive  If you are unsure of the answer, don’t guess or make something up. Refer to a document, procedure or find someone who will know the answer.

12. The ideal Auditee  Admit if something is wrong – if possible try to correct it at the time of the inspection by following correct procedures  Don’t criticise or blame others for any errors  Be polite and enthusiastic!

13. Be a good host  Make the inspectors feel welcome  Book rooms  Provide documents, PC’s, printers, telephone  Think about what refreshments they will need ie tea/coffee

14. Last minute checks  Work areas are clean and tidy  Staff are prepared  Documentation is available  Key staff availability  Rooms prepared  Refreshments/parking sorted out

15. On the day of the inspection Relax

16. Show them around

17. Stick with them  Inspectors should always be accompanied  Security  It’s polite  It’s amazing what you can find in some cupboards and drawers

18. Examples of Questions you may be asked  Quality  How do you know which SOPs apply to you?  And which do apply to you?  How are you trained on these?  How often are you trained on SOPs?  What do you do if you have a question about SOPs?  What do you do if you can’t access the SOPs?

19. Example questions continued  Training  Who maintains your training record?  Tell me about its contents?  Where is kept?  Who has access to it?  When does your manager look at it?  How often should you have GLP training?  When did you last have GLP training?

20. Example questions continued  Archiving  Talk me through the archiving process  Who is responsible for archiving documents?  For how long are your files and folders archived?  How would you go about retrieving something from archive?  How would this be recorded?

21. Once it’s all over  Take time to reflect on how it went  De-brief and thank staff for their hard work  Share the experience  Produce an action plan  Respond to the Inspectors report  Track to completion ready for the next inspection.

22. Summary  Inspectors are human  Be polite, honest, helpful and show confidence  Defend your view appropriately  Be enthusiastic  Know your systems