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1. GMP Inspection Process
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Module20 Slide1of 35 January2006
The Inspection

2. The Inspection
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Module20 Slide2of 35 January2006
Objectives
1. To discuss the process of conducting an inspection
2. To review a number of inspection techniques
3. To discuss issues you may encounter when performing an
inspection

3. Timetable
 Entry briefing/opening meeting
 Orientation tour
 Fact finding and assessment
 Review progress against audit plan
 Revised activity
 Final review/recommendations
 Exit review with management/closing meeting
 Report with time frame
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Module20 Slide3of 35 January2006
The Inspection

4. Getting Started
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Module20 Slide4of 35 January2006
 Location
 Contact
 Time
 Introductions
 Walk-round
 Company escort
The Inspection

5. Remember that an Inspection….
 Is a systematic approach
 Involves interpersonal skills
 Identifies deficiencies
 Looks at what went wrong
 Requires participation from both parties
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Module20 Slide5of 35 January2006
The Inspection

6. The Inspection
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Module20 Slide6of 35 January2006
Methods of Fact-Finding
 Trace forward
 Trace backward
 Random

7. The Inspection
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Module20 Slide7of 35 January2006
Asking Questions…..
Open questions starting with:
 What
 Why
 When
 How
 Where
 Who
Silence can be very powerful

8. The Inspection
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Module20 Slide8of 35 January2006
Good Listening – I
 Stop talking!
 Help the speaker to feel free to talk
 Be approachable
 Show the speaker that you are interested
 Remove distractions
 Try to understand the speaker’s point of view

9. The Inspection
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Module20 Slide9of 35 January2006
Good Listening – II
 Be patient
 Hold your temper
 Try not to criticize
 Ask questions
 Stop, look and listen

10. The Inspection
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Module20 Slide10of 35 January2006
Group Session 1
 You will be given a situation about which you have to determine
the factual information regarding the situation. The people being
inspected will be truthful, but will not volunteer any extra
information
 List up to 5 questions that you would ask in order to obtain the
information that you require

11. The Inspection
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Module20 Slide11of 35 January2006
How to Take Notes
 Detail and facts — trust, but verify
 Specifics not generalizations
 Record detail as seen
 Ensure accuracy
 Be open

12. The Inspection
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Module20 Slide12of 35 January2006
What to Record – I
 Persons interviewed
 Document numbers
 Equipment numbers
 Item identification

13. The Inspection
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What to Record – II
 Selection of document recipients
 Condition of environment
 Changes to facilities, equipment, etc.
 Layout of area
 Any obvious non-conformities

14. The Inspection
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Module20 Slide14of 35 January2006
How to Record – I
 Checklists
 Flowcharts/process charts
 Symbols such as a star (*) or a tick
 Checks and follow-up

15. The Inspection
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Module20 Slide15of 35 January2006
How to Record – II
 Highlights
 Short notes for the report (reminders)
 T
ape recorder
 Video camera
 Camera

16. The Inspection
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Checklists
 Are structured
 Detailed
 Standard for all full inspections
 Advantages
 Useful as reference
 Good for training inspectors
 Disadvantages
 Can lead to overlooking vulnerable areas of QA

17. The Inspection
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Module20 Slide17of 35 January2006
Checklists – How to Use Them
 Follow, but be prepared to be flexible
 Use in preparation stage
 Use to collect information and chart progress
 Preparation for the exit meeting
 Preparation of the report

18. The Inspection
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Module20 Slide18of 35 January2006
Aide-Memoire
 Simple, short list of actions and aspects to be checked
 Tailored for the inspection
 Checklist and/or an aide-memoire

19. The Inspection
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Module20 Slide19of 35 January2006
Taking Samples
 Finished-released products
 Raw materials
 In-process materials
 Inspector or sampler
 Number of samples and sample size
 Authorization

20. The Inspection
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Module20 Slide20of 35 January2006
Objectives of Exit Meeting
 Communicate observations
 Inform management of findings
 No surprises in report

21. The Inspection
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Preparing for Exit Meeting – I
 Group non-compliances
 Categorize non-compliances
 critical, major and minor

22. The Inspection
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Preparing for Exit Meeting – II
 Anticipate questions and discussion or debate
 In the case of a team of inspectors
 agree on a spokesperson
 agree on a note-taker

23. The Inspection
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Exit Meeting Attendees
 The inspectors
 Senior management representative
 Inspected managers and supervisors
 Other interested parties

24. The Inspection
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Running the Meeting – I
 Inspectors must lead
 Concise presentation
 Discussion
 When to invite discussion and when to limit the discussion
 Mention good points before deficiencies

25. The Inspection
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Module20 Slide25of 35 January2006
Running the Meeting – II
 Treat challenges politely
 Discuss and resolve conflicts
 Admit if wrong
 Don’t back down if convinced you are right

26. The Inspection
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Module20 Slide26of 35 January2006
Writing the Inspection Report
 Each team member writes own part
 Team leader has overall responsibility
 Signed by all team members
 Approval from supervisor
 To company within 4 weeks or less

27. The Inspection
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Module20 Slide27of 35 January2006
Report Content
 Part 1. General information on company
 Part 2. Description of the inspection
 Part 3. Observations
 Part 4. Conclusion and recommendation
 Annexes

28. The Inspection
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Do Not Include
 Subjective opinions
 Irrelevant information
 Ambiguous statements
 Antagonistic statements

29. The Inspection
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Style of Report
 Use past tense
 Keep it simple and based on fact
 Include a summary

30. The Inspection
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Module20 Slide30of 35 January2006
Report with Covering Letter to Company
 Any corrective actions to be taken
 Time limits for implementing them
 Confidential information
 Exchange of reports
 Regulatory measures if not implemented

31. The Inspection
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Module20 Slide31of 35 January2006
Regulatory Measures
Depend on national legislation. Examples:
For new plants
 No manufacturing licence/GMP certificate until compliance
For licence/certificate holders
 Warnings
 Fines
 Suspension/withdrawal of marketing authorization for
product(s)
 Suspension/withdrawal of manufacturing licence/GMP
certificate
 Access to appeal

32. The Inspection
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Module20 Slide32of 35 January2006
Group Session 2
 You will be provided with a set of observations arising from an
inspection of a factory
 Review the observations, categorize them, prepare corrective
actions and prepare for the exit meeting with the company

33. The Inspection
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Module20 Slide33of 35 January2006
Company Strategies – I
Tricks
Time-wasting
Side-tracking
Provocation
Samples provided
Special case
Circular argument
Remedies
Threaten to extend inspection
Stick to programme
Remain calm
Select your own sample
Take notes and keep looking
Recognize and stop

34. The Inspection
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Module20 Slide34of 35 January2006
Company Strategies – II
Tricks
Trial of strength
Insincerity
Pity
Absentees
Amnesia
Remedies
Be firm; know your facts
Ignore it
Sympathize; carry on
Call for deputy
Go back and get it yourself

35. The Inspection
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Module20 Slide35of 35 January2006
Group Session 3
 On arrival, you are met by one of the company Vice-Presidents.
You waste some time before starting the inspection, as they
want to make a presentation of the company to you first. They
had also planned lunch at a restaurant and some of the key
persons of the departments you want to inspect are not
available.
 What went wrong?
 How could it have been avoided?
 Use examples from your own experience to illustrate how you
can handle situations where the manufacturer wants to prevent
you from doing a thorough inspection.