3. Intentions of Audits
To verify the systems /process as committed by the firm, in view of
patient safety.
To collect the evidences (that the correct medicine with assured quality
is achieving to patient)
He may be
our relative
or we
own!!!
4. Reason for Audits
To verify the:
Assessing
complian
ce status
Approving
of new
facilities
Issuing
new
permission
s
Renewing
of license
Periodic
visits
Investigations
purpose
Recalls
Serious complaints
Counterfeits
Due
diligence
Business or
technical
capabiliti
es
Periodic
reviews of
complianc
es
5. Importance of Audits
New business opportunities
Business continuity
Market leadership advantages
Easier and faster regulatory approval
System compliances
To improve quality management systems
To improve the quality of product
To meet the cGMP
7. Opening Meeting
Do’s
Welcome of Auditors
Self introductions
Share business Cards
Scope of audit should be discussed
Limited general talk with mild smile
Notify auditors up fronts
8. Opening Meeting
Do’s
Effective presentation with soft colors
Tea or Coffee should be ready
Bouquet or flower should be on table
Map the facility describing various area
Print out the copy of presentation
Keep ready the Organizational chart
Remember!!!
First Impression is the last
impression
9. Opening Meeting
Don'ts
Absent during welcome
Long talk
Absence of subject matter
Exceed smile
Through business cards
Take long time for discussion
Whisper
10. Preparations for Audit
Back room should be strong
Subject matter experts should be present
All possible documents should be available
Runner for fetching of document in time
Person as “SCRIBE” to keep notes
Extra stationary should be available (transparent folders, stapler,
stapler pins, office files, etc….
Washroom facility should be in executive conditions
Lunch should with suitable food
11. Preparations for Audit
All Quality Documents should be reviewed
Product related informations should be
available
APQR from last three years (minimum)
Process flow diagram
Vendor details and documents
RM details (using in manufacturing)
Hazardous material handling informations
Information about Product manufacturing at
site
Facility housekeeping along with surroundings
Safety practices
Safety slogans
Emergency numbers, ambulance availability
Preventive maintenance documents
Paste control documents
Recruitment policy
Attendance system policy
Outside training details
Workmen training details
Dressings of employees should be clean
Personnel hygiene awareness
12. Back room
Review of documents quickly before of it goes in to hands of Auditor.
Give and take record
Qualification records
All department SOPs
Site master file, VMP, Quality Manual
Stability data
Particular product validation (process and cleaning), BMR, Specifications
Site lay out
Experts for subjects
13. Facility Tour
Facility housekeeping should be excellent
Outlook should be perfect (Painting, Lightening and scheduling)
All shop floor personnel should be confident for their work
Be clear and be transparent with respect to our work
Knowledge of subject which is being done
Flawless tour from Material entry to Material exit
If found any deficiency : first convince the auditor if it is actually not
which auditor under stood.
If it is deficiency then accept it and commit to resolve.
14. Documentation
Do’s
Should be given within 5 minutes
Should be in presentable condition.
Serve the document on desk to desk
Remove documents if it is review (with permission)
Reply only those questions which are asked
Be clear during Q&A with inspector / auditor
Speak with confidence
Answer with facts along with evidences
Every thing which is said to auditors should be on record
15. Documentation
Don’ts
No mixing of documents
No additional reply or over answer
Don’t use work “I think”
Don’t argue during discussion (by third person)
Use word “excuse me” if any addition
Don’t afraid of silence
Don’t leave alone the inspector / auditor
Don’t laugh more than enough
16. During the Audit
Unacceptable points:
Become defensive and start arguments
Make blunt refusals on the requests
Speculate or guess an answer
Respond to questions outside your expertise
Attempt to answer a hypothetical question
Intentionally mislead of lie
Start blaming others or departments for the mistakes
Make any personal comment on the quality of the investigator
Generate questions by offering un-requested information or asking questions of the
Investigator
Recording investigator discussions in the audit room
17. Your behavior
Should be
Polite
Good listener
Good Acceptor
Positive attitude
Technically sound
Well experienced subject matter
Gentle
Well dressed
Good convincer
Supportive
Should not be use “I”
Think
Suppose
Believe
Usually
Sometimes
By practices
To be honest
18. Wrap up
Take a diary for notes (general observations)
Thanks speech for auditing the facility
Share the learning's
Keep eye contacts
Ask “is there any critical issue”.
Arrange to provide documents (is asked by auditor during audit)
Gifts hand over session if required
Leave them up to their Cars
Say “bye and take care”
19. Response
Say thanks after receiving of observation report
Provide time line for the completion of compliance report
Share the compliance report along with evidences
Follow up for the receipt of the compliance report
Follow up for the closing of observations