WHO training on Good Manufacturing Practices (GMP). Module 2: GMP Inspection Process Lesson 1: The inspection

1. Module 20 | Slide 1 of 35 January 2006
GMP Inspection Process
The Inspection

2. Module 20 | Slide 2 of 35 January 2006
The Inspection
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. Module 20 | Slide 3 of 35 January 2006
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
The Inspection

4. Module 20 | Slide 4 of 35 January 2006
Getting Started
 Location
 Contact
 Time
 Introductions
 Walk-round
 Company escort
The Inspection

5. Module 20 | Slide 5 of 35 January 2006
Remember that an Inspection….
 Is a systematic approach
 Involves interpersonal skills
 Identifies deficiencies
 Looks at what went wrong
 Requires participation from both parties
The Inspection

6. Module 20 | Slide 6 of 35 January 2006
The Inspection
Methods of Fact-Finding
 Trace forward
 Trace backward
 Random

7. Module 20 | Slide 7 of 35 January 2006
The Inspection
Asking Questions…..
Open questions starting with:
 What
 Why
 When
 How
 Where
 Who
Silence can be very powerful

8. Module 20 | Slide 8 of 35 January 2006
The Inspection
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. Module 20 | Slide 9 of 35 January 2006
The Inspection
Good Listening – II
 Be patient
 Hold your temper
 Try not to criticize
 Ask questions
 Stop, look and listen

10. Module 20 | Slide 10 of 35 January 2006
The Inspection
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. Module 20 | Slide 11 of 35 January 2006
The Inspection
How to Take Notes
 Detail and facts — trust, but verify
 Specifics not generalizations
 Record detail as seen
 Ensure accuracy
 Be open

12. Module 20 | Slide 12 of 35 January 2006
The Inspection
What to Record – I
 Persons interviewed
 Document numbers
 Equipment numbers
 Item identification

13. Module 20 | Slide 13 of 35 January 2006
The Inspection
What to Record – II
 Selection of document recipients
 Condition of environment
 Changes to facilities, equipment, etc.
 Layout of area
 Any obvious non-conformities

14. Module 20 | Slide 14 of 35 January 2006
The Inspection
How to Record – I
 Checklists
 Flowcharts/process charts
 Symbols such as a star (*) or a tick
 Checks and follow-up

15. Module 20 | Slide 15 of 35 January 2006
The Inspection
How to Record – II
 Highlights
 Short notes for the report (reminders)
 Tape recorder
 Video camera
 Camera

16. Module 20 | Slide 16 of 35 January 2006
The Inspection
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. Module 20 | Slide 17 of 35 January 2006
The Inspection
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. Module 20 | Slide 18 of 35 January 2006
The Inspection
Aide-Memoire
 Simple, short list of actions and aspects to be checked
 Tailored for the inspection
 Checklist and/or an aide-memoire

19. Module 20 | Slide 19 of 35 January 2006
The Inspection
Taking Samples
 Finished-released products
 Raw materials
 In-process materials
 Inspector or sampler
 Number of samples and sample size
 Authorization

20. Module 20 | Slide 20 of 35 January 2006
The Inspection
Objectives of Exit Meeting
 Communicate observations
 Inform management of findings
 No surprises in report

21. Module 20 | Slide 21 of 35 January 2006
The Inspection
Preparing for Exit Meeting – I
 Group non-compliances
 Categorize non-compliances
 critical, major and minor

22. Module 20 | Slide 22 of 35 January 2006
The Inspection
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. Module 20 | Slide 23 of 35 January 2006
The Inspection
Exit Meeting Attendees
 The inspectors
 Senior management representative
 Inspected managers and supervisors
 Other interested parties

24. Module 20 | Slide 24 of 35 January 2006
The Inspection
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. Module 20 | Slide 25 of 35 January 2006
The Inspection
Running the Meeting – II
 Treat challenges politely
 Discuss and resolve conflicts
 Admit if wrong
 Don’t back down if convinced you are right

26. Module 20 | Slide 26 of 35 January 2006
The Inspection
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. Module 20 | Slide 27 of 35 January 2006
The Inspection
Report Content
 Part 1. General information on company
 Part 2. Description of the inspection
 Part 3. Observations
 Part 4. Conclusion and recommendation
 Annexes

28. Module 20 | Slide 28 of 35 January 2006
The Inspection
Do Not Include
 Subjective opinions
 Irrelevant information
 Ambiguous statements
 Antagonistic statements

29. Module 20 | Slide 29 of 35 January 2006
The Inspection
Style of Report
 Use past tense
 Keep it simple and based on fact
 Include a summary

30. Module 20 | Slide 30 of 35 January 2006
The Inspection
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. Module 20 | Slide 31 of 35 January 2006
The Inspection
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. Module 20 | Slide 32 of 35 January 2006
The Inspection
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. Module 20 | Slide 33 of 35 January 2006
The Inspection
Company Strategies – I
Tricks Remedies
Time-wasting Threaten to extend inspection
Side-tracking Stick to programme
Provocation Remain calm
Samples provided Select your own sample
Special case Take notes and keep looking
Circular argument Recognize and stop

34. Module 20 | Slide 34 of 35 January 2006
The Inspection
Company Strategies – II
Tricks Remedies
Trial of strength Be firm; know your facts
Insincerity Ignore it
Pity Sympathize; carry on
Absentees Call for deputy
Amnesia Go back and get it yourself

35. Module 20 | Slide 35 of 35 January 2006
The Inspection
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.