MHRA Inspection Readiness By Lulu Cvetkovic NICR QA Manager

Expect notification

First of all DO NOT

What you should do is…

What you need

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

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

Get everyone involved

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

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.

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!

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

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

On the day of the inspection Relax

Show them around

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

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?

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?

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?

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.

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