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WHY???
GOOD DOCUMENTATION PRACTICES
Because,
If you did not document it, it did not happen!
QMS & GMP REQUIREMENT
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Describe:• Methods of recording of data• Rectification of written data
Includes:• Documentation on paper• In electronic form• Photocopy of another document
GOOD DOCUMENTATION PRACTICES
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SOP is applicable to:
• Master documents
• Records being maintained
• Training, validations, qualifications, calibrations
and maintenance of manufacturing equipment &
utility systems, etc.
GOOD DOCUMENTATION PRACTICES
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Responsibility:• Department heads
Strict adherence of personnel to GDP
• Executive QA / designeeMonitoring of documentation procedures
• Head qualityOverall control over documentation
GOOD DOCUMENTATION PRACTICES
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GOOD DOCUMENTATION PRACTICES
Document should be:• Clear• Precise• Accurate• Legible• Unambiguous
Prohibitions• Erasable ink• Correction fluid• Use of Pencils
GOOD DOCUMENTATION PRACTICES
CLEARLY RECORD THE DATA
What is that?
29? 27? No I think its 24?
Ummm.. What do we do now???
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GOOD DOCUMENTATION PRACTICES
When Documenting:
• Direct transcription onto Document
• Legible writing
• Blue indelible ball point pen
• Put initials to authenticate
• Justify overwriting
• Date format: DD/MM/YYYY
• Time format: 24:00 Hrs …
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GOOD DOCUMENTATION PRACTICES
When Documenting:
• No rounding off in BOM & Dispensing records
• Documents with boxes or spaces: Each one will be completed without exception,
If not applicable: ‘-’ or ‘NA’ as appropriate• Data in margin:
Initialed, dated and linked to respective data
…
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GOOD DOCUMENTATION PRACTICES
When Documenting:
• Page/ part of page not applicable
Diagonally cross, sign and date
• Data to be repeated:
Write it, No ditto signs
• Do not write on backside of page
• No Backdating
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GOOD DOCUMENTATION PRACTICES
Annexure or attachment:
• Initialed and signed
• Reference No. of principle document
• Filed or affixed with principle document
• Binary page numbering system “Page X of Y”
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GOOD DOCUMENTATION PRACTICES
Photocopying:
• Same record to be used for several documents
• Original record not immediately available
• No hiding of information while photocopying
• Reference No. of original document
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GOOD DOCUMENTATION PRACTICES
Rectification of Data: No modification without QA approval To be done by person who recorded or supervisor Blue indelible ball point pen Strikethrough with single line DATA Allow easy reading of cancelled data Prohibitions:• Erasable ink• Correction fluid• Use of Pencils
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GOOD DOCUMENTATION PRACTICES
Rectification of Data:• Corrected information
Near as possible to the crossed out information
Initialed and dated Brief but clear explanation
• Insufficient space Use blank space on page Link by distinctive sign *
…
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Rectification of Data:• Numerous corrections or spoilt document
Re-transcript on new document after QA approval
Initial document to be attached to new document
New document shall bear following remark:
"Document recopied from the original attached in annex".By : and after acceptance by Quality AssuranceDate : Sign :
GOOD DOCUMENTATION PRACTICES
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Thank you
