1 / 35

GMP Inspection Process

GMP Inspection Process. The Inspection. 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. The Inspection. Timetable

Download Presentation

GMP Inspection Process

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

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.

More Related