Date post: | 15-Feb-2017 |
Category: |
Health & Medicine |
Upload: | omkar-phutane |
View: | 388 times |
Download: | 13 times |
1
WHY???
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
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.
GOOD DOCUMENTATION PRACTICES
4
Responsibility:• Department heads
Strict adherence of personnel to GDP
• Executive QA / designeeMonitoring of documentation procedures
• Head qualityOverall control over documentation
GOOD DOCUMENTATION PRACTICES
5
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???
7
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 …
8
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
…
9
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
10
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”
11
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
12
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
13
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 *
…
14
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
15
Thank you