GMP Inspection Process The Inspection Module 20 | Slide 1 of 35 January 2006
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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
Module 20 |
Slide 2 of 35
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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Slide 3 of 35
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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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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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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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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