This is a brief information for handling of auditors as well as customers / CQA inspections

1. By: Shravan Dubey
Facing Audits/Inspections

2. Internal Audits
/ Self
Inspections
Customer
Audits
Kinds of Audits
Audits
Regulatory
Audits
Other audits
(ISO, EHS,
CQA,
commercial
visits)

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

6. Facing of AUDIT

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

20. Thank You