Transcript 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 review a number of inspection techniques
3. To discuss issues you may encounter when performing an
inspection
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January 2006
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
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The Inspection
Getting Started
 Location
 Contact
 Time
 Introductions
 Walk-round
 Company escort
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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
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The Inspection
Methods of Fact-Finding
 Trace forward
 Trace backward
 Random
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The Inspection
Asking Questions…..
Open questions starting with:
 What
 Why
 When
 How
 Where
 Who
Silence can be very powerful
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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
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The Inspection
Good Listening – II
 Be patient
 Hold your temper
 Try not to criticize
 Ask questions
 Stop, look and listen
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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
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The Inspection
How to Take Notes
 Detail and facts — trust, but verify
 Specifics not generalizations
 Record detail as seen
 Ensure accuracy
 Be open
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The Inspection
What to Record – I
 Persons interviewed
 Document numbers
 Equipment numbers
 Item identification
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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
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The Inspection
How to Record – I
 Checklists
 Flowcharts/process charts
 Symbols such as a star (*) or a tick
 Checks and follow-up
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The Inspection
How to Record – II
 Highlights
 Short notes for the report (reminders)
 Tape recorder
 Video camera
 Camera
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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
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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
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The Inspection
Aide-Memoire
 Simple, short list of actions and aspects to be checked
 Tailored for the inspection
 Checklist and/or an aide-memoire
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The Inspection
Taking Samples
 Finished-released products
 Raw materials
 In-process materials
 Inspector or sampler
 Number of samples and sample size
 Authorization
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The Inspection
Objectives of Exit Meeting
 Communicate observations
 Inform management of findings
 No surprises in report
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The Inspection
Preparing for Exit Meeting – I
 Group non-compliances
 Categorize non-compliances
 critical, major and minor
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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
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The Inspection
Exit Meeting Attendees
 The inspectors
 Senior management representative
 Inspected managers and supervisors
 Other interested parties
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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
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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
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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
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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
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January 2006
The Inspection
Do Not Include
 Subjective opinions
 Irrelevant information
 Ambiguous statements
 Antagonistic statements
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The Inspection
Style of Report
 Use past tense
 Keep it simple and based on fact
 Include a summary
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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
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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
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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
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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
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January 2006
Recognize and stop
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
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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.
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January 2006