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

The Inspection Objectives 1. To discuss the process of conducting an inspection 2. To 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 Module 20 | Slide 2 of 35 January 2006

The Inspection Timetable l Entry briefing/opening meeting l Orientation tour l Fact finding and The Inspection Timetable l Entry briefing/opening meeting l Orientation tour l Fact finding and assessment l Review progress against audit plan l Revised activity l Final review/recommendations l Exit review with management/closing meeting l Report with time frame Module 20 | Slide 3 of 35 January 2006

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

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

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

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

The Inspection Good Listening – I l Stop talking! l Help the speaker to The Inspection Good Listening – I l Stop talking! l Help the speaker to feel free to talk l Be approachable l Show the speaker that you are interested l Remove distractions l Try to understand the speaker’s point of view Module 20 | Slide 8 of 35 January 2006

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

The Inspection Group Session 1 l You will be given a situation about which The Inspection Group Session 1 l 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 l List up to 5 questions that you would ask in order to obtain the information that you require Module 20 | Slide 10 of 35 January 2006

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

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

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

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

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

The Inspection Checklists l Are structured l Detailed l Standard for all full inspections The Inspection Checklists l Are structured l Detailed l Standard for all full inspections l Advantages ä Useful as reference ä Good for training inspectors l Disadvantages ä Can lead to overlooking vulnerable areas of QA Module 20 | Slide 16 of 35 January 2006

The Inspection Checklists – How to Use Them l Follow, but be prepared to The Inspection Checklists – How to Use Them l Follow, but be prepared to be flexible l Use in preparation stage l Use to collect information and chart progress l Preparation for the exit meeting l Preparation of the report Module 20 | Slide 17 of 35 January 2006

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

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

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

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

The Inspection Preparing for Exit Meeting – II l Anticipate questions and discussion or The Inspection Preparing for Exit Meeting – II l Anticipate questions and discussion or debate l In the case of a team of inspectors ä agree on a spokesperson ä agree on a note-taker Module 20 | Slide 22 of 35 January 2006

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

The Inspection Running the Meeting – I l Inspectors must lead l Concise presentation The Inspection Running the Meeting – I l Inspectors must lead l Concise presentation l Discussion ä When to invite discussion and when to limit the discussion l Mention good points before deficiencies Module 20 | Slide 24 of 35 January 2006

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

The Inspection Writing the Inspection Report l Each team member writes own part l The Inspection Writing the Inspection Report l Each team member writes own part l Team leader has overall responsibility l Signed by all team members l Approval from supervisor l To company within 4 weeks or less Module 20 | Slide 26 of 35 January 2006

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

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

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

The Inspection Report with Covering Letter to Company l Any corrective actions to be The Inspection Report with Covering Letter to Company l Any corrective actions to be taken l Time limits for implementing them l Confidential information l Exchange of reports l Regulatory measures if not implemented Module 20 | Slide 30 of 35 January 2006

The Inspection Regulatory Measures Depend on national legislation. Examples: For new plants ä No The Inspection Regulatory Measures Depend on national legislation. Examples: For new plants ä No manufacturing licence/GMP certificate until compliance For licence/certificate holders ä Warnings ä Fines ä Suspension/withdrawal of marketing authorization for product(s) ä Suspension/withdrawal of manufacturing licence/GMP certificate ä Access to appeal Module 20 | Slide 31 of 35 January 2006

The Inspection Group Session 2 l You will be provided with a set of The Inspection Group Session 2 l You will be provided with a set of observations arising from an inspection of a factory l Review the observations, categorize them, prepare corrective actions and prepare for the exit meeting with the company Module 20 | Slide 32 of 35 January 2006

The Inspection Company Strategies – I Tricks Remedies Time-wasting Threaten to extend inspection Side-tracking 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 Module 20 | Slide 33 of 35 Recognize and stop January 2006

The Inspection Company Strategies – II Tricks Remedies Trial of strength Be firm; know 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 Module 20 | Slide 34 of 35 January 2006

The Inspection Group Session 3 l On arrival, you are met by one of The Inspection Group Session 3 l 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. ä What went wrong? ä How could it have been avoided? l 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. Module 20 | Slide 35 of 35 January 2006