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 äUseful as reference äGood for training inspectors Disadvantages äCan 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 äcritical, 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 äagree on a spokesperson äagree 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 äWhen 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 äNo manufacturing licence/GMP certificate until compliance For licence/certificate holders äWarnings äFines äSuspension/withdrawal of marketing authorization for product(s) äSuspension/withdrawal of manufacturing licence/GMP certificate äAccess 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 TricksRemedies Time-wastingThreaten 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 TricksRemedies Trial of strengthBe firm; know your facts InsincerityIgnore it PitySympathize; carry on AbsenteesCall for deputy AmnesiaGo 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. äWhat went wrong? äHow 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.