The document outlines good documentation practices (GDP) required for quality management systems (QMS) and Good Manufacturing Practice (GMP). It emphasizes the importance of clear, accurate, and precise documentation methods, including various prohibitions on materials and practices such as the use of erasable ink and correction fluid. Key responsibilities for adherence and oversight are assigned to department heads and quality assurance personnel.

1. WHY???
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GOOD DOCUMENTATION PRACTICES
Because,
If you did not document it, it did not happen!
QMS & GMP REQUIREMENT

2.  Describe:
• Methods of recording of data
• Rectification of written data
 Includes:
• Documentation on paper
• In electronic form
• Photocopy of another document
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GOOD DOCUMENTATION PRACTICES

3.  SOP is applicable to:
• Master documents
• Records being maintained
• Training, validations, qualifications, calibrations
and maintenance of manufacturing equipment &
utility systems, etc.
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GOOD DOCUMENTATION PRACTICES

4.  Responsibility:
• Department heads
Strict adherence of personnel to GDP
• Executive QA / designee
Monitoring of documentation procedures
• Head quality
Overall control over documentation
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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

6. 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 Assurance
Date : Sign :
GOOD DOCUMENTATION PRACTICES

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