module 20 | slide 1 of 35 january 2006 gmp inspection process the inspection
TRANSCRIPT
Module 20 | Slide 1 of 35 January 2006
GMP Inspection ProcessGMP Inspection Process
The Inspection
Module 20 | Slide 2 of 35 January 2006
The InspectionThe 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 3 of 35 January 2006
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
The Inspection
Module 20 | Slide 4 of 35 January 2006
Getting Started
Location
Contact
Time
Introductions
Walk-round
Company escort
The Inspection
Module 20 | Slide 5 of 35 January 2006
Remember that an Inspection….
Is a systematic approach
Involves interpersonal skills
Identifies deficiencies
Looks at what went wrong
Requires participation from both parties
The Inspection
Module 20 | Slide 6 of 35 January 2006
The InspectionThe Inspection
Methods of Fact-Finding
Trace forward
Trace backward
Random
Module 20 | Slide 7 of 35 January 2006
The InspectionThe Inspection
Asking Questions…..
Open questions starting with:
What
Why
When
How
Where
Who
Silence can be very powerful
Module 20 | Slide 8 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 9 of 35 January 2006
The InspectionThe Inspection
Good Listening – II
Be patient
Hold your temper
Try not to criticize
Ask questions
Stop, look and listen
Module 20 | Slide 10 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 11 of 35 January 2006
The InspectionThe Inspection
How to Take Notes
Detail and facts — trust, but verify
Specifics not generalizations
Record detail as seen
Ensure accuracy
Be open
Module 20 | Slide 12 of 35 January 2006
The InspectionThe Inspection
What to Record – I
Persons interviewed
Document numbers
Equipment numbers
Item identification
Module 20 | Slide 13 of 35 January 2006
The InspectionThe Inspection
What to Record – II
Selection of document recipients
Condition of environment
Changes to facilities, equipment, etc.
Layout of area
Any obvious non-conformities
Module 20 | Slide 14 of 35 January 2006
The InspectionThe Inspection
How to Record – I
Checklists
Flowcharts/process charts
Symbols such as a star (*) or a tick
Checks and follow-up
Module 20 | Slide 15 of 35 January 2006
The InspectionThe Inspection
How to Record – II
Highlights
Short notes for the report (reminders)
Tape recorder
Video camera
Camera
Module 20 | Slide 16 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 17 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 18 of 35 January 2006
The InspectionThe Inspection
Aide-Memoire
Simple, short list of actions and aspects to be checked
Tailored for the inspection
Checklist and/or an aide-memoire
Module 20 | Slide 19 of 35 January 2006
The InspectionThe Inspection
Taking Samples
Finished-released products
Raw materials
In-process materials
Inspector or sampler
Number of samples and sample size
Authorization
Module 20 | Slide 20 of 35 January 2006
The InspectionThe Inspection
Objectives of Exit Meeting
Communicate observations
Inform management of findings
No surprises in report
Module 20 | Slide 21 of 35 January 2006
The InspectionThe Inspection
Preparing for Exit Meeting – I
Group non-compliances
Categorize non-compliances critical, major and minor
Module 20 | Slide 22 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 23 of 35 January 2006
The InspectionThe Inspection
Exit Meeting Attendees
The inspectors
Senior management representative
Inspected managers and supervisors
Other interested parties
Module 20 | Slide 24 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 25 of 35 January 2006
The InspectionThe Inspection
Running the Meeting – II
Treat challenges politely
Discuss and resolve conflicts
Admit if wrong
Don’t back down if convinced you are right
Module 20 | Slide 26 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 27 of 35 January 2006
The InspectionThe Inspection
Report Content
Part 1. General information on company
Part 2. Description of the inspection
Part 3. Observations
Part 4. Conclusion and recommendation
Annexes
Module 20 | Slide 28 of 35 January 2006
The InspectionThe Inspection
Do Not Include
Subjective opinions
Irrelevant information
Ambiguous statements
Antagonistic statements
Module 20 | Slide 29 of 35 January 2006
The InspectionThe Inspection
Style of Report
Use past tense
Keep it simple and based on fact
Include a summary
Module 20 | Slide 30 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 31 of 35 January 2006
The InspectionThe Inspection
Regulatory Measures
Depend on national legislation. Examples:For new plants
No manufacturing licence/GMP certificate until complianceFor licence/certificate holders
Warnings Fines Suspension/withdrawal of marketing authorization for
product(s) Suspension/withdrawal of manufacturing licence/GMP
certificate Access to appeal
Module 20 | Slide 32 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 33 of 35 January 2006
The InspectionThe 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
Module 20 | Slide 34 of 35 January 2006
The InspectionThe 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 35 of 35 January 2006
The InspectionThe 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.