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GOOD LABORATORY PRACTICE
DOCUMENTATION
Sunando Basu M.Pharm (Quality Assurance), RQAP-GLP
Head Quality Assurance- VIVO BIO, Hyderabad
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Good Laboratory Practice-Documentation
Why it is so important?
What if I don’t document?
What do we mean by document?
What are the requirements of documentation?
How can I fulfill the requirements?
What should I remember?
KEY QUESTIONS?
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Good Laboratory Practice-Documentation
WHY IT IS SO IMPORTANT???
Documents are the Life-blood of the Organization!
Demonstrate what actually went on at the time…
Critical for complete reconstruction of the study…
Authentication that all the required procedures were correctly carried
out at the correct time…
Regulatory requirement…
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Good Laboratory Practice-Documentation
WHAT IF I DON’T DOCUMENT???
Experimental data are lost…
Complete record is not made…
Lost/ Incomplete document may invalidate study…
Impossible to justify as the usual believe is…
Regulatory action…
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Good Laboratory Practice-Documentation
WHAT DO WE MEAN BY DOCUMENT?
Descriptive document…
Results of original measurements, observations, and activities
associated with the study which may be needed to verify and evaluate
the study…
Which will provide a picture of what actually happened during the
course of an activity…
Examples are: Raw Data in Laboratory Notebook, Logbook,
Forms, Project Binder/File,
Paper Printout, Electronic Format, All
type of records…
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Good Laboratory Practice-Documentation
DOCUMENTATION TYPE…
Handwritten Documentation
Entry IntoElectronic System
Copying RawData
Transcription ofPaper RecordsTo Computer
Database
Electronic Data Capture
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Good Laboratory Practice-Documentation
WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?
Identifiable…
Promptness…
Accurateness…
Legibility…
Signature and Date…
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Good Laboratory Practice-Documentation
Therefore the document should show:
“What was done”…
“How it was done”…
“When the work was performed”…
“Who performed the work”…
WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?
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Good Laboratory Practice-Documentation
HOW CAN I FULFILL THE REQUIREMENTS?
Record data
Directly into the required format and not transcribed from
a rough copy…
Promptly…
Accurately…
Legibly…
Then…
Sign and date…
Note: Sign indicates who has performed the work and
date identifies when the work was performed…
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Good Laboratory Practice-Documentation
Any correction made during and or latter recording should be
explained for…
Reason for correction…
The signature of the individual making the correction…
The date the correction was made…
WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?
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Good Laboratory Practice-Documentation
HOW CAN I FULFILL THE REQUIREMENTS? Contd..
Therefore, remember to…
Make a single line through the error…
Record the correct entry on the above or next to the
original entry with the reason for correction…
Then Sign and date…
Note: Correction codes can be used to simplify the explanation but shall
be clear to the third party…
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Good Laboratory Practice-Documentation
HOW CAN I FULFILL THE REQUIREMENTS? Contd..
276 275 Error in writing SB 31-10-2006
Correct Entry
Reason for Correction
Sign and Date
PRACTICE THIS
AND NOT THIS
276
276
Over writing
Scribbling
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Good Laboratory Practice-Documentation
WHAT SHOULD I REMEMBER?
Documentation…
Paramount importance…
All information blanks that require data input must be completed…
Record data to its completeness…
Never assume that something written in SOP or Protocol are not
required to be documented…
Always sign and date…
Never indulge in Fraudulence…
Follow company’s SOP on Good Documentation Practice at all time…
Never discard original record…
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Good Laboratory Practice-Documentation
Documentation Constitutes An Essential Part Of
The Quality Management System
Should show complete History of AUDIT TRAIL
BOTTOM LINE…
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Good Laboratory Practice-Documentation
