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GMP Inspection Process

GMP Inspection Process

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GMP Inspection Process

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Presentation Transcript

  1. GMP Inspection Process The Inspection

  2. 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. The Inspection 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

  4. The Inspection Getting Started • Location • Contact • Time • Introductions • Walk-round • Company escort

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

  6. The Inspection Methods of Fact-Finding • Trace forward • Trace backward • Random

  7. The Inspection Asking Questions….. Open questions starting with: • What • Why • When • How • Where • Who Silence can be very powerful

  8. 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. The Inspection Good Listening – II • Be patient • Hold your temper • Try not to criticize • Ask questions • Stop, look and listen

  10. 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. The Inspection How to Take Notes • Detail and facts — trust, but verify • Specifics not generalizations • Record detail as seen • Ensure accuracy • Be open

  12. The Inspection What to Record – I • Persons interviewed • Document numbers • Equipment numbers • Item identification

  13. 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. The Inspection How to Record – I • Checklists • Flowcharts/process charts • Symbols such as a star (*) or a tick • Checks and follow-up

  15. The Inspection How to Record – II • Highlights • Short notes for the report (reminders) • Tape recorder • Video camera • Camera

  16. 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. 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. 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. The Inspection Taking Samples • Finished-released products • Raw materials • In-process materials • Inspector or sampler • Number of samples and sample size • Authorization

  20. The Inspection Objectives of Exit Meeting • Communicate observations • Inform management of findings • No surprises in report

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

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

  24. 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. 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. 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. 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. The Inspection Do Not Include • Subjective opinions • Irrelevant information • Ambiguous statements • Antagonistic statements

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

  30. 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. 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. 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. 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. The Inspection Company Strategies – II TricksRemedies 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. 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.