Understand and Survive an FDA InspectionKaren S. Ginsbury, Bpharm, MSc, MRPharmS IVT’s 4th Annual Validation Week Copenhagen, Denmark March 2013
Agenda• Pre-inspection• The inspection• After the inspection
Pre-Inspection• Six weeks to one month notice – and they will want to see production going on• MUST reply to the notice of inspection – fast. Only propose delay IF there is a valid reason e.g. you know there is a planned shutdown and tell FDA that saying “we are happy to host the inspection at the proposed dates, but we wish to clarify that we have a planned maintenance shutdown from … to … and we will not be producing any of our USA market products at that time.
Preparations• NOTIFY management and SMEs – especially the SMEs who need to start revising for their exam because we don’t want them saying “give me the deviation so I can remember what happened”• Management assigns a person who is IN CHARGE of the inspection OR that is already known in the company / in a job description – they will MANAGE the preparations
Preparations• Prepare a detailed checklist: – REVIEW actions (CAPAs) to previous inspection findings and similar issues to make sure they are now compliant – All deviations from the past two years – All change controls as above – All CAPA items: complaints, OOS results, rejected batches, rejected in-process material, maintenance records, logbooks…internal audit findings (COMPANY CONFIDENTIAL) – (Training records)
Preparations• Company walk-through – gross signs of housekeeping issues and documentation – all those unsigned notices pasted up with operating ranges, instructions etc. Printouts lying around in the QC lab with no accompanying test or notebook, “my copy” of an SOP• War room – for the inspection we have an inspection room – a meeting assigned ONLY for that purpose and entry is by invite only
Preparations• Assign a scribe or two – someone who writes up non-stop the course of the inspection – every time the inspector is writing – the scribe is writing• Assign someone (it might be the scribe) who writes down requests – any document that is requested
Keep the inspector Happy• Prepare an opening presentation – SHORT and to the point• A few details about the company history• Organogram• Number of employees and QA/QC employees• Layout of the production area• Have a printed copy ready for the inspector along with business cards of the key personnel who are introduced at the opening meeting• Between 10 minutes to 30 minutes or you can have a continuation for a first time inspection with more detail which you offer as an option
Keep the inspector Happy• We assume you are guilty: cheats, thieves and liars - their starting point is NOT that you are OK• Put yourself in their shoes• DON’T interrupt them. If they are writing – you write as well or the scribe does and let them get on with it – DO NOT interrupt their train of thought• Someone (SME) comes into the room to present – they sit down WITH PHONE OFF and WAIT until asked
Dos and Don’ts• NEVER ever lie – always answer truthfully but don’t rush to tell what you perceive as the WHOLE truth• Listen carefully to the question• Answer ONLY the question you were asked• Wait until the inspector has FINISHED asking the question• If the inspector is silent don’t panic – just WAIT – DON’T talk
Dos and Don’ts• An employee or anyone under stress does NOT have to answer in English – there can be anyone in the room who is authorised who can translate their answer• Keep your really “enthusiastic” guys WELL away from the inspector or give them a vacation.• THE INSPECTOR may be able to speak or understand your native language – THEY ALL understand body language• “the huddle” – they ask a question and five of your guys, go pale and start whispering for a few minutes in frantic tones and then say “yes”
Dos and Don’ts• Once you say “no” it’s hard to gain credibility for “yes”• IF you have any document that is seriously close to what is being asked for present it• Don’t be shy to ask them to repeat a question• Don’t be shy to ask them to clarify a question
Dos and Don’ts• An SME needs “context” for a question so the person who hears the question needs to try and capture that on the document request form• All documents brought to the inspector should be reviewed for absence of sticky notes, pencilled annotations etc.
Good and Bad Phrases• Bad – is “that’s not good science”• That’s not what FDA wants• Interrupt the inspector mid sentence and tell them “it’s really important…”• Good: “we thought this was the right thing to do and would like to try to explain but if it is wrong we will put it right”
Asking for explanations• Be cautious – the FDA is not your GMP consultant – You are supposed to be familiar with the regulations
Site tour• Don’t have a million people tagging along• Don’t show off – throughout the inspection – you don’t want to look good – you want to pass the inspection• Don’t volunteer information
Site metrics• If you normally have them up – and it is a quality tool – leave it there
• Don’t get into a slanging match – if you don’t agree with the inspector – respectfully try to present your point of view – once but then just say we understand your concern and will address• Don’t do quick fixes
Wrap up meeting• They present the findings• DON’T try to respond to each one – just commit to putting things right voluntarily• IF there is something really inaccurate say so.
response• GET a detailed targeted response in within 15 working days or you will get a warning letter.