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Documentation
The First & Last Exit in GMP
02 Nov 2019, Karachi
Regulatory Expectations
1 Regulatory Expectations
If someone reads detail
procedure to swim
Can he swim independently?
Opening Question
100% 50% 10% 0%
1
How much you are sure that someone
can manufacture tablets if he follows
the written SOP and these tablets will
be of desired quality?
Opening Question
100% 50% 10% 0%
2
Operation Documentation
Operation DocumentationDevelopment Process
Procedure Execution Recording
Procedure Execution Recording
Procedure Execution Recording
Documentation Documentation
Procedure Execution Recording
Documentation Documentation
Operations
Record that describes how an
activity, event or process was
actually performed
Procedure Execution Recording
Documentation Documentation
Procedure Execution Recording
Documentation Documentation
Operations
Record for describing activity,
event or process
(i.e. recordkeeping)
Procedure Execution Recording
Documentation Documentation
Compacted Micronized
Question
Word “Compacted” was left to be
recorded on label of SMZ drums
What can be the consequences?
3
Question
A breakdown in tray dryer happened after 25
minutes, it was noticed after 45 minutes while
temperature went down.
It was manufacturing of antihypertensive
drug that was reprocessed without recording
the incidence. What may go wrong?
4
Thank You

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Documentation - The First and Last Exit in GMP