FDA INSPECTION READINESS
FDA INSPECTION READINESS
FDA Readiness
• Before the inspection
• Set up for Inspection (Inspection team / Room setup)
• Opening Meeting
Tour of the facility
Do’s and Don’t s During the inspection
Typical Questions During Inspection
Daily wrap-up and Final close-out
After the inspection / Next Steps
FDA INSPECTION READINESS
Before Inspection:
Conduct Mock Inspection / Gap Analysis
Create CAPA Plan for any Gaps
Execute remediation
Continuous walk through of the facility / cleanliness of the
facility
Be pro-active and Be Prepared / Know your job
Do not shy away or hide from the process.
Have SMEs trained to address inspectors questions
FDA INSPECTION READINESS
What will they look at?
Computers
Validation, if compliant with CFR Part 11
Procedures
Appropriately approved and followed / periodical review
Complaints
Resolved and closed as per internal procedure
Rejected batches
Laboratory controls
Removed from inventory and isolated as per procedure
Process / reference standards / method validation / method transfer
/ raw data
Labels, Components Storage & security / usage / consolidation
In-process materials Testing / QA oversight
Validation processes Equipment / E-system / Computer software / Methods / Cleaning
Finished/released
materials
Testing / Release of the final product
Logbooks, records and
Appropriately assigned / Reviewed and approved
documents
Overall facility
Buildings, equipment, materials, cleaning procedures, HVAC, etc.
FDA INSPECTION READINESS
Typical
Onsite
Inspection
Team
Quality Head (Host)
Scribers (typically 2 –
front and back room)
Document Controller
SMEs for each
department
Quality control Laboratory
Production and packaging
Facilities and Warehouse
IT
Document Runners
FDA INSPECTION READINESS
Inspection Front Room
Document
Controller
Scriber 1
Quality
Head
(Host)
Index cards
with Request
#
Auditor 1
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Scriber 2
Requested
Document
Files
Request #
Documents
Being Reviewed
Document
Runner
Auditor 2
FDA INSPECTION READINESS
Inspection Back Room
Customer
SMEs
Document
Runner to
Front Room
Requested
Document
Files
SMEs
Backroom
Scriber 1
Presentation Name | CONFIDENTIAL
Backroom Document
Scriber 2 Request #
FDA INSPECTION READINESS
Opening Meeting – Short
Presentation
Introduction of the management, Quality
staff and employee present in the room
Organizational Chart (Indicate who is the
management)
Presentation about the facility/layout,
plan tour, hour of operations
FDA INSPECTION READINESS
Managing the inspection…
• Control documents provided to the inspector
• Keep log of requests and their status…
Mark “Confidential” and “Copy” to all copied
documents provided
• Review the requested record before sending
into the room for the investigator. Check
that the record is the one asked for.
• Send only the record and not the entire file.
• Check for any missing signatures or entries
or missing pages
FACILITY TOUR DURING INSPECTION
Tour of the facility with Inspectors
• Identify key QA and respective department
SMEs to escort Inspectors
• Escort the inspectors at all times
• Tour – flow the material and production
process
• Incoming materials / warehouse (raw
materials, packaging material)
• Quarantine / Approve material area
• Production (manufacturing to finish goods
area)
• QC Lab
FACILITY TOUR DURING INSPECTION
Tour of the facility with Tour of the facility with Inspectors (continues)
• Restrict conversations in common areas and/or to the area only being toured
• Be prepared to show to which process or relevent SOP for the work performed in the area.
• Questions –
• Address only if the available information is accurate
• Ensure you understand the questions before answering.
• Take note of the questions asked or document requested
• Take note of any document reviewed by the inspectors
• Take note of any employees interviewed during the walkthrough
• Always be truthful, if information not available or not known, it’s okay to say “I don’t know,
let me find out”
HANDLING FDA INSPECTION - DO'S
Do’s
Be confident
Be well dressed and neat.
Be presentable
Be decent and polite
Be courteous and professional at all times
Correct all errors/miscommunications as
soon as possible
HANDLING FDA INSPECTION - DO'S
Do’s
Require that all requests from the inspector go
through your inspection team
Provide documents in an accurate and timely manner
Handle document requests with care, ensure that
only requested document is provided
Review requested document prior to presenting to the
inspector ensure it’s completion
Limit the inspector’s access to the records, facilities
and materials that are subject to inspection
HANDLING FDA INSPECTION - DO'S
Do’s
Check that no undue paper is appended to the record.
Ask for clarification when necessary
Avoid undue traffic in and out of the room.
Remove records which have been reviewed from the room
Show one record at one time
Have all records organized and available
Have all relevant documents/raw data readily accessible –
preferably assembled in one central location.
Be very familiar with content and location of all reports/data, SOPs
etc.
Avoid Long delays in responding to questions
HANDLING FDA INSPECTION - DO'S
Do’s
Make thorough notes of
comments/concerns/ deficiencies
pointed out by the inspector.
Clarify or attempt to resolve issues
as it becomes known.
Be cooperative with the
investigator to the extent possible,
but politely disagree when
appropriate
Be brief in what you say “no” to
any questions
Try to Develop a “Relationship”.
You know the product and process
better than FDA and that needs to
be conveyed.
However don’t pass slips / notes to each
other.
HANDLING FDA INSPECTION - DO'S
When a
question
is
asked…
Take a deep breath
Listen carefully to the Inspector’s questions
Pause and formulate a proper response
Answer only after the question is fully stated.
Request clarification to questions not understood
Answer only what was asked
Provide a clear, concise, and honest answer
Only answer questions within your job responsibilities
otherwise direct the question to “Subject Matter Experts”
HANDLING FDA INSPECTION - DO'S
When a Speak slowly and clearly-one word at a time
question
is
Keep unnecessary conversation to a minimum
asked…
Answer briefly to the question only
Answer only if you are sure.
Communicate clearly and effectively
Focus on positives
HANDLING FDA INSPECTION - DO'S
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DO’s
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Assume a friendly, cooperative attitude - but do
not overdo it.
 Avoid creating an adversary relationship. Project
an attitude of confidence and professionalism.
 If management is seen as "uncooperative," the
investigator may well become suspicious and
more zealous.
 Review pertinent plant policies e.g., policies
pertaining to cameras, recorders, wearing apparel,
and safety equipment during the opening interview
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HANDLING FDA INSPECTION - DO'S
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DO’s
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Acknowledge and document areas that you know need
development.
If the inspector is ‘digging’ or asking the same basic
question, provide more information as answers may not be
complete.
Talk about what is and not what might be or should be.
If a problem has surfaced, point out where GMP and quality
system controls have worked and how improvements have
been made.
Often, it is appropriate to include a plan for corrective action.
Inspectors wants to see that management is taking these
issues seriously.
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
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Do not try to “Snow” the inspector, wrong information is
worse than no information.
Don’t try to control the conversation
Don’t try to lead the inspection
Don’t try to change the agenda
Avoid language using typically, normally, generally, and
usually, as possible
Guess, lie, deny the obvious, or make misleading
statements
Engage in unconstructive argument. (Avoid win/lose or
legalistic confrontations.)
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
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Do not write and implement Standard Operating
Procedure that are overly complex and above the
required standards.
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You will be inspected to your SOPs as well as the
regulatory requirements.
Failing to meet your SOPs will result in inspection
finding even if you are meeting the regulatory
requirements.
Don’t write rigid SOPs instead where possible use
‘guidance’
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
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Don’t try any distraction techniques
Speak unless spoken to or questions asked
Attempt to answer “What if?” questions or
hypothetical questions
Become argumentative or, worse, hostile or make
threatening remarks.
Engage in arguments with peers in the presence
of inspectors
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
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Don’ts Allow inspectors to go through your files on their
own. Ask them what they want and provide it for them.
Refuse appropriate requests from inspectors, but try to
narrow the scope of the request when possible
Do not try to hinder the progress of the Auditor by time
consuming idle conversations, lengthy presentations or
non-relevant alternate agendas
Don’t waste inspector’s time
Do not challenge the auditor’s understanding of the
requirements and regulations.
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
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Ask questions to the auditor
 Show off your knowledge.
 Defend your answer by giving reference of
guideline or book
 Get aggressive or be ‘clever’
 Joke with the investigator
 Say that something is impossible or couldn’t
happen. (This is a red flag that challenges the
inspector to find a way it could happen.)
 Chat in places the auditor may be i.e. toilets,
corridors etc.
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
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Correct other people in front of the Inspector
Do not initial/sign any error in front of the
inspectors
Interrupt someone else’s answer
Interrupt the Inspector’s comments and
explanations
Provide your opinions
Answer for someone else
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
Don’t have food in the lab
 Have clutter in your work area
 Quote what the SOP says, unless you’re 200%
certain you know what you’re talking about
 Be intimidated or defensive
 Don’t leave documents out on your desk.
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
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Leave inspectors alone while they are in your plant
Tell inspectors that records are unavailable. You can say that
you cannot locate the record
Tell inspectors they are being unreasonable (even when
they are)
Ask questions such as, “Where does it say we have to do
that?” Their response will likely be “Where does it say that
you don’t?”
Do not answer questions which lie outside the authority of
the Inspector (sales data, personnel information relating to
salaries, performance reviews, etc)
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HANDLING FDA INSPECTION – DON’TS
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DON’Ts
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When reviewing Records
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Point out errors
Correct errors during the review
Comment or “apologize” for the quality of the data
Comment on plans to improve recordkeeping
practices, unless criticized by the Investigator
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HANDLING FDA INSPECTION – DON’TS
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Choose your responses correctly “To be
really honest with you ………..” OR “To
tell you the truth ………”
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Unofficially…
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Off the record…
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HANDLING FDA INSPECTION – DON’TS
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Be wary of the “Long silence technique”
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Auditor asks you a question
You answer
Auditor listens
Auditor maintains a long silence (purposely)
You become anxious to break the silence
You add more to the answers (mostly unwanted!)
Auditor got enough to grill you!
Don’t be over anxious to break the silence, answer only to the
point, not a word more
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TYPICAL QUESTIONS DURING INSPECTION…
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Question to expect…
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Quality Policy – What it is and how is it applied in the facility
quality system?
Job responsibility – how do you know what to do on your job?
Deviations, Investigations, OOS, Complaints – How many in a
quarter or past two years and how do you manage them?
Relevant SOPs.
Supplier Quality or How vendors are qualified and audited?
Management Review, Frequency? Agenda? Participants?
Training – How are employees trained for their job
responsibilities and process for requalifications?
Laboratory – Instrument qualification, validation and/or
calibration, test method validation
Data Integrity Policy – how data is secured and ensure accuracy
of it?
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MANAGING THE INSPECTION – DAILY WRAP UP
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Daily Wrap up:
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Regroup and try to address the concerns /
comments for the day
 Ask the inspector if there are any open issues for
that day or any concerns not address during the
day
 Confirm they are done with the topic
 Confirm next day start time
 Collect request of documents that they would like
to review next day, so all can be available first
thing next day
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MANAGING THE INSPECTION – FINAL CLOSE OUT
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Final Close-out:
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Request a closing meeting – Even it no issues found
Confirm the date / time with the inspector and invite
management
This is not the time to argue with the inspector
Ask questions as needed for any calification of any issues
found or clear understanding of any concerns presented
Request for final report or list of observation/findings from
the inspectors
Find out response deadline and next steps…
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AFTER INSPECTION / NEXT STEPS
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After Inspection Steps:
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Regroup with internal respective SMEs, and the
management
Clearly understand any findings or concerns raised by the
inspectors at the close-out
Initiate discussion on drafting constructive response with
clear timeline and plan for any corrective actions needed
Submit the response within allowed deadline. Do not wait for
last minute submission.
Goal is continuous improvement
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Be prepared to MANAGE the inspection –
Establish roles and responsibilities before the
inspection – Have the necessary resources to
accommodate the number of inspectors
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QUESTIONS ?
| CONFIDENTIAL