How to face a Audit

1. 1
TYPES OF INSPECTIONS
• INTERNAL
• 1)INTERNAL AUDIT BY Q.A.
• 2)BY AUDIT TEAM FROM
ACCOUNTS
• EXTERNAL
1) BY GOVT.
AUTHORITIES
FDA,EXCISE,
LABOUR WELFARE,
FACTORY INSPECTOR,
POLLUTION CONTROL BOARD
OTHERS
2)CUSTOMER AUDITS
3)ENERGY AUDITS
4)BY FOREIGN AUTHORITIES

2. 2
Quality system approach to GMP Inspection
1. Pre – Approval Inspection (PAI)
2. CGMP Inspections are carried out Biennial (every tow
years)
Targets of this Inspections are Manufacturers & Policies.
Objectives are as follows:
Assure correlation between Manufacturing process for :
a) Clinical trial
b) Bioavailability study
c) Stability studies
d) Submission information

3. 3
Quality system approach to GMP Inspection
3. “For cause” Inspection, e.g. Field Alert
filing, other health risks brought to
Regulatory attention.

4. 4
System Based CGMP Inspection
System based CGMP Inspection involves:
1.Quality System
2. Facility
3. Equipment
4.Utility
5. Materials
6. Production
7. Laboratory Controls
8. Packaging & Labeling
If one of the eight systems is out of control, the company is
considered out-of-control

5. 5
1.Quality System & Management Approach:
1. Assure overall compliance with CGMP regulations and
all quality systems.
2. Quality must be built into the process & Quality is not
tested into the product
3. Quality Assurance review Quality System and trending
& involved in continuous improvement within well
characterized process.
4. It should assures overall compliance with CGMPs.

6. 6
5.Quality Unit Reviews and approves
following,
a) Annual Product Quality Reviews
b) Complaints
c) Deviations/Failure Investigations
d) Change Control
e) CAPA
f) Reprocess/Rework
g) Validation/Revalidation
h) Rejects
i) Stability Failures/Out of Trend data
j) Quarantine Products
k) Documented Training – GMP and Job Related

7. 7
2. Facilities:
1. Location, design and construction of facility should be
appropriate , to facilitate operations, maintenance and
cleaning.
2. Layout and air – handling are designed and
constructed in such a way to prevent cross-
contamination
3. Flow of materials and personnel - designed to prevent
mix- ps or contamination such as incoming Materials,
Sampling Area, Quarantine Area, Released Area,
Rejected material.
4. Separate facilities for hormones and highly potent
compounds should be provided.

8. 8
3.Equipment:
1. Equipment should be of appropriate design, size,
location and non-reactive product contact surfaces.
2. It should be clearly marked by code number for it’s
identification.
3. Before installation it’s Qualification (DQ,IQ,OP,PQ)
and calibration should be performed.
4. Maintenance department should prepare Preventive
Maintenance Schedule and procedures.

9. 9
Equipment
5. Equipment cleaning procedures and cleaning validation
should be performed to prevent contamination and
mix-ups
6. Equipment Usage Log: Cleaning and maintenance
should; be maintained.
7. Lubricant ,heating fluids or coolant should not alter
product quality.
8. Equipment should be closed & Inspection should be
done prior to use.

10. 10
4. Utility
• Utility system involves following utilities:
1. HVAC system
2. Water system
3. Piping system
4. Drawing as Built

11. 11
UTILITY
• Other Utilities:
1. Electricity
2. ETP system
3. Compressed Air system
4. Dust Extraction system

12. 12
UTILITY
• All above system should be Qualified,
validated, approved & appropriately
monitored
• Water used for sterile dosage form should be
monitored and controlled for total microbial
counts, objectionable organizations and
endotoxins

13. 13
5. Materials System:
1. Material can include APIs, raw materials, process
water,gas etc.
2. Material should be taken only from approved Vendor.
3. Periodic audit of supplier should be performed.
4. Change Control should be filled for changing suppliers
and suppliers’ processes
5. Process Flow and written Procedures –Receipt,
Identification, Quarantine, Storage, Handling,
Sampling, Testing and approval/rejection of material
should be according to CGMP.

14. 14
6.Production System:
1. Production and process controls should ensure safety,
identity, strength, purity, quality of finished products.
2. Product should be validated & consistently produced.
3. Data should be documented and available to Quality
Unit review – trending, investigation etc.
4. GMP & job related training should be given to all
employees.
5. MFR, BMR, BPR, Change Control Procedure, In-
process Control charts, tests, examinations,equipment
Logs- Cleaning, Calibration, Qualifications, SOP’s etc.
document should be well maintained & updated.

15. 15
7.Laboratory Control System:
1. Laboratory Procedures should be in place to ensure the
accuracy of test results.
2. Quality Control Unit should be independent of
production & should have adequate lab facilities, staff
& supervisory bench personnel.
3. Written specifications – raw materials, APIs,
intermediates, labels, packaging & finished products
should be available in lab.
4. Written procedures –sampling, testing, approval or
rejection of materials, recording and storage of data
should be there.
5. Change control approval should be taken before any
change.

16. 16
Laboratory Control System:
6. Reference standard – primary, secondary should be
available in the lab.
7. Equipment Qualification, calibration & maintenance
should be documented properly.
8. OOS Procedures for the timely investigation,
documentation and conclusion of OOS investigation
should be scientifically sound and justified.
9. Test Results of raw material, inprocess & finish product
should be documented & Signed by person who perform
it.

17. 17
1. Process Flows & written Procedures receipt,
identification, quarantine, sampling, testing and
approval/rejection of packaging and labeling
materials should be maintained.
2. Label Storage Area – Should have enclosed
(locked), limited access.
3. Reconciliation should be properly documented &
investigation should be done if any discrepancy is
observed.
8.Packaging & Labeling System:

18. 18
4. All excess labels coded with batch number, to be
destroyed and documented
5. Print labels checked against master and a copy placed
with the batch record.
6. Packaging operations should be designed to prevent
mix-ups.
8.Packaging & Labeling System:

19. 19
Management Responsibilities
A) Management Responsibilities involves:
1. Document Organogram of employee to ensure the
assigned authorities and responsibilities. It should be
including Name, Revision No., Effective date.
2. Management should support the total quality model .
3. The Quality Manager has the authority to detect
problems ,implement solutions, and provide prompt
feedback on quality issues to the organization.
4. It play a key role in the design, implementation, and
management of robust quality systems

20. 20
5. Actively participate in Management Review meetings – to
ensure continuing suitability, adequacy, and effectiveness
6. It advocate continuous improvement of the operation of
Quality System.
a) Strong and visible support for the quality system
b Internal communication on quality issues at all levels
7. Management controls such as CAPA***,People
qualifications & Training Records, Change control,
Validation are always reviewed by Regulatory bodies, so
it is responsibility of management to keep all these
document updated. `
Management Responsibilities
A) Management Responsibilities involves:

21. 21
B) Resources
1. It involves General Arrangements of Infrastructure,
materials, products, testing
2. Personnel Development including Organizational
culture, Qualifications and responsibilities
3. Management should supply and maintain the
appropriate facilities and equipment
4. Control Outsourced Operations such as Quality
Agreements& Qualifications and standards.

22. 22
5. QC is responsible for Analyze finished products and
materials – collection, storage, examination of inprocess,
stability, and reserve samples
6. HR department should be involved in new entrant training.
It should be Problem solving and communicative in
culture. They should define qualification and assign
appropriate responsibilities such as Education, training
and experience.
7. Manufacturing department should be involved in Design,
develop and document Product and Processes by experts
by analyzing critical processes. It is involved in Examining
material & in performing and monitoring operations. It
also address Nonconformities.
8. Evaluation Activities are done by conducting internal
Audits (self Inspection), Analyzing Data for trends &
CAPA
B) Resources

23. 23
Most Common Observations of
Regulatory Inspections:
1) No or inadequate procedures or procedures not
followed
2) No management review of procedures
3) Management oversight / QA oversight
4) QC unit did not follow procedures
5) No internal audits performed
6) Inadequate employee training

24. 24
7) process not validated
8) Inadequate laboratory controls
9) Raw data not reviewed/maintained
10) No procedures for handling OOS situations
11) No procedures for Corrective and preventive actions
12) Recurring deviations
Most Common Observations of
Regulatory Inspections:

25. 25
How to minimize the risk of receiving
non-compliance?
1. Know regulations and guidelines – the quality intent
and meaning
2. Know the consequences of deviations of non –
compliance – Both staff and management
3. Study 483s and Warning Letters from internet – Learn
about mistakes others have made
4. Build up a quality system in line with industry
standards, regulations and guidelines

26. 26
5. Develop SOP’s on Preparing for Inspections
6. Ongoing training to staff and management on GMP
trends and new regulations
7. Respond to Regulatory observations effectively and
timely.
How to minimize the risk of receiving
non-compliance?

27. 27
Conclusion
1. Implementation of a comprehensive, robust Quality system
Model
2. Proactive approach to achieve long – term benefits
3. Characteristic of a Successful Quality System:
a) Science Based Approaches
b) Understand the intended use of a product
c) Identify and control potential weak processes
d) Timely remediation of deviation and investigation
e) Sound methods for assessing and reducing risks
f) Well defined processes and products – Product life Cycle
g) Systems for careful analysis of product quality
h) Supportive Management – philosophically and
financially

28. 28
Thank You!

29. 29
How to Host Regulatory / Quality Audits
Audit Sequence should be as follows:
1. Audit the analyst to describe the process.
2. Observe the process.
3. Read the SOP.
4. Check the records

30. 30
1. Ask how OOSs are investigated in QC and R&D
Labs, how OOS is captured in LIMS
2. At Receiving  Ask how samples are received into
LIMS
At Laboratory  Ask how Lab Manager schedule
samples for testing using LIMS
At QA  Ask how they approve samples and
C of As using LIMS
Style – Looking for Consistency
Consistency among Different Department / Different
Sites

31. 31
1. Company should Knows the GMP relates to their
products or services
2. Company should knows why it has to do, in this way.
3. Company should provides documentation to show that
the products are tested correctly, as per registration
(NDA)
4. Company should have consistent approach in different
departments
Quality Auditor’s/ Inspector’s Expectation

32. 32
1. Understand GMP
2. Understand roles and responsibilities of self and direct
reports
3. Demonstrates ability to justify, rationalize and defend
at high level
4. Demonstrate control of the functional area.
5. Knowledge of area’s process and operational SOP’s
6. Knowledge of trends, failures, OOS, and recurring
deviations
7. Knowledge of major projects, volumes, and capacities
Expectation from Senior Managers

33. 33
1. He should understand the processes and products
2. GMP related activities, e.g. Equipment IQ,OQ,PQ
program, validation status etc.
3. Able to present processes clearly – High Level
4. He/She should Know the quality trends, e.g. OOS,
complaints, recurring issues, CAPA & Training
Records.
Expectation from Section Heads/Area
Managers

34. 34
1. He/She should Know the processes, SOP’s
and products – in detail
2. Present with clarity
3. Training records
Expectation from Experts

35. 35
Expectations from Technical Staff
Analyst/Specialist/Operator/Engineer/Project
Leader should -
1. Demonstrate control of the tasks
2. Detailed knowledge and skills of SOP’s
3. Detailed knowledge and ‘hands-on’ experience in
generation and recording of logbooks, and other
supporting activities in your area.

36. 36
Investigator want to see PITCH
What is PITCH?
It is totality of,
1.Professionalism
2.Integrity
3.Technical Expertise
4.Communication Skills
5.Honesty

37. 37
Professionalism
What is professionalism?
Professional means you should -
1. Be prepared – Has information, documents, and thought
organized and ready
2. Speaks of what he/she knows, defers to others as
necessary
3. Works and speaks efficiently
4. Conveys confidence in words and action
5. Concerned with quality results
6. Speaks about pertinent issues, not personalities or
unrelated topics
7. Conveys pride in own functional areas and company

38. 38
Integrity
What is Integrity?
Integrity means you should -
1. provides information, professional opinions, or
impressions that are based on actual events and
documents
2. Appropriate represents facts, possibilities, and
professional opinions
3. Corrects any potentially misunderstandings quickly
and courteously
4. Is willing to take appropriate responsibility

39. 39
Technical Expertise
Technical Expertise is a person who -
1. Mentally prepares the answer and presents it in a
logical manner
2. Provide scientific rationale.
3. Provides facts, documents and professional opinions as
requested
4. Arrive at a valid, technically defending conclusion by
considering ALL data and information

40. 40
Communication – Vocal
1. Speaks understandably at an appropriate rate, pitch
and volume
2. Uses words, phrases that are respectful, appropriate,
and thoughtful; not judgmental or emotionally charged
3. Speech patterns are efficient; pauses are used for
thoughts
4. Tone of voice is neutral or pleasant

41. 41
Communication – Non – Verbal
1. Body posture conveys interest, confidence and openness
2. Hands and gestures are used for emphasis
3. Eye contact conveys interest, confidence and helps with
the “connection”
4. Nervousness is appropriately managed by deep
breathing and preparation
5. Overall appearance is professional and appropriate

42. 42
Honesty
1. Admit mistakes
2. Willing to take appropriate
responsibility

43. 43
Inspector’s Targets
1. The greatest patient risks come from:
a) Unexpected Deviations
b) Change Controls
c) Errors(OOS, Product/Method Transfer)
2. Quality Management:
a) CAPA
b) Complaints
c) Rejected Batches,Retests,Re-assays
d) Personnel
3. Interfaces between departments and sites

44. 44
Easy Targets for Inspection
1. Analysts not correctly garmented
2 Identification stickers peeling off from equipment
3. Rooms & equipment with no status labels
4. Lack of security to the Label storage areas
5. Area that is cluttered
6. Illegible identification tags
7. Unsigned documents

45. 45
Checkpoints before Audit -
1. What is in your garbage bin?
2. Protection of your password
3. Cleanliness of area
4. Are you wearing the correct garments or not?

46. 46
Other Preparations
Facilities
1. First Impression
2. Housekeeping
3. Visual factory/Posters/Pictures
4. Lab coats
5. Staff

47. 47
How to Interact with the Inspector?
1. Always tell the truth.
2. Provide information as rapidly as possible.
3. Understand the question before answering.
4. Keep your responses short, but up to the point.
5. Don’t talk and work at the same time, expect to
demonstrate your work to the inspector

48. 48
How to Interact with the Inspector?
6. Answer questions professionally, courteously, and
carefully
7. Answer with facts.
8. It’s acceptable to say that you don’t know.
9. Correct or clarify any misinformation provided to
the inspector.

49. 49
Types of Questions asked by Inspector’s
1. Direct questions –
“Do you have an SOP for ………………?”
2. Leading questions –
“Why did/didn’t you …………………..?”
3. Open – ended questions
“Tell me some more about that…………”

50. 50
How to respond to the Auditor?
1. Don’t take them personally
2. Respond
a) Positively
b) Professionally
3. Never lose your temper!

51. 51
Answering Questions
1. Person with direct knowledge of the answer.
2. Don’t provide a “hearsay” answer.
3. Don’t answer for another department, if not sure
4. Speak from personal knowledge
5. Use SOP to resolve uncertainty

52. 52
Style - The Long Silence Technique
Only answer the question which is asked
…………then keep quiet!

53. 53
Style – Intimidation Technique
1. Don’t be intimidated
2. Make sure that you understand the question &
make sure the inspector understands your answer

54. 54
DO’s During the Inspection
1. If the inspector is ‘digging’ or asking the same basic
question, provide more information as answer may not
be complete.
2. Talk about what is and not what might be or should be.
3. It a problem has surfaced, point out where GMP and
quality system controls have worked and how
improvements have been made.
4. If an activity went well, tell why.

55. 55
Inspector’s Requests
1. Satisfy requests for documents quickly
2. Only provide what is requested – and no
more …………..

56. 56
What Arouse Suspicions?
1. Data that is “too good”
2. SOPs all bear same revision date
3. SOPs not followed as written
4. Evasive answers to avoid commitment or answer
indirectly

57. 57
What Arouse Suspicions?
5. Body language/ eye contact
6. Obvious confusion among staff
7. Stalling tactics – Taking too long to obtain documents –
Asking for the same information many times and not
getting it.
8. Hiding unpleasant deviations, OOSs’ etc

58. 58
What you will do ,When you know that
there is a problem
1. Check the most recent OOS or deviation, and it should be
properly completed the investigation and explain the
situation.
2. Auditor’s doesn’t expect perfection – That’s why we have a
QA system
3. What was done about the problem? (CA)
4. What is the plan for future actions?
5. How will you prevent recurrence? (PA)
6. Always tell the truth

59. 59
Managing the Difficult Encounters
1. Understand what the investigator is asking
2. Know the limits to your knowledge
3. Don't feel pressured or intimidated
4. Don’t fill the gaps with wrong information or
personal opinions
5. Maintain professionalism and integrity
6. Signal QA Host for help

60. 60
Don’ts - During the Inspection
1. Don’t try to control the conversation
2. Don’t try to change the agenda
3. Don’t waste inspector’s time
4. Don’t try any distraction techniques
5. Don’t leave an inspector alone
6. Don’t volunteer information
7. Don’t try to buy them expensive dinner or gifts

61. 61
Confrontation
Avoid confrontation
YOU CAN NOT WIN

62. 62
Phrases to Avoid : ‘I think this is what
happens …….”
1. Unacceptable if responsible
2. Do not create your answer
3. Admit your uncertainty
4. Find the right person

63. 63
Phrases to Avoid: ‘Well, normally …….’
1. How about abnormal situations?
2. Have you documented and validated process for
abnormal situations?
3. Only answer question asked

64. 64
Phrases to Avoid: ‘Its too expensive’
1. Unacceptable
2. Suggest alternatives

65. 65
Phrases to Avoid: ‘Not my problem’
1. Negative reaction
2. Trigger investigation of all aspects of control

66. 66
Phrases to Avoid: ‘We have changed the
process.’
1. Out of date SOP
2. Changes which impact on product quality
3. Lack of change control
4. SOPs must be current

67. 67
Don’t be afraid to say “no”
Inspector: “I worked on one of those many
years ago. That’s a nice looking HPLC. Do
you mind if I just press some of these
buttons?”

68. 68
More Examples of Bad Comments
1. Yes. Yes. Yes…….
2. I’ m glad you’re here this week instead if the last
week.
3. This is not my job. I’ve just transferred to this
department last week.
4. I think this is the way to do it. I’m not sure.
5. I was never trained on this process.

69. 69
More Examples of Bad Comments
6. I don’t know anything. I just work here.
7. No problem, honey.
8. I’ve told my manager/staff many times, but he ignores
the problem.
9. I know this is the right process but it takes too long.
10.We don’t have time to log the info. We enter data at the
end.

70. 70
Most Examples of Bad Comments
1. We are too busy right now.
2. This equipment is non-GMP.
3. We have passed the other regulatory inspections in
the past.
4. I don’t get support from other department.
5. We have been doing this for years
6. We have a budget restraint to hire more people.
7. That should not have happened. My staff should not
have done that.

71. 71
Before Meeting the Investigators
1. Clearly define your area of responsibility or knowledge.
2. Have a working knowledge of the products, policies,
methods and SOPs
3. Know why you do certain things. What is the (written)
rationale?
4. Think through possible questions
5. Review the documents for weakness and prepare to
answer questions

72. 72
The Golden Rules
1. Be prepared and be confident
2. If you do not know, admit it
3. Wrong answer versus 5 minutes wait and get right
answer
4. Promptly provide documents

73. 73
Respect: A Two Way Process
1. Remember the inspector is professional with an
important and necessary job.
2. Respect the inspector’s professionalism and they are
more likely to respect yours

74. 74
Key to success: People
1. Competent
2. Confident
3. Credible
4. Knowledgeable
5. Honest
6. Able to demonstrate the strength of your company

75. 75
……….and finally…………
1. Be concise, courteous, direct and honest in your
dealings with investigators and stay cool
2. Don’t argue, speculate or blame others for mistakes
3. Remember inspectors are there to protect consumers/
patients by making sure we are producing quality
products and services
4. That’s our job too!

76. 76
Thank You !