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Good Laboratory Practice Documentation

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Good Laboratory Practice Documentation

  1. 1. GOOD LABORATORY PRACTICE<br />DOCUMENTATION<br />SunandoBasuM.Pharm (Quality Assurance), RQAP-GLP<br />Head Quality Assurance- VIVO BIO, Hyderabad<br />
  2. 2. Good Laboratory Practice-Documentation<br />KEY QUESTIONS?<br />Why it is so important?<br />What if I don’t document?<br />What do we mean by document? <br />What are the requirements of documentation?<br />How can I fulfill the requirements? <br />What should I remember?<br />2<br />
  3. 3. Good Laboratory Practice-Documentation<br />WHY IT IS SO IMPORTANT???<br />Documents are the Life-blood of the Organization!<br /> Demonstrate what actually went on at the time…<br /> Critical for complete reconstruction of the study…<br />Authentication that all the required procedures were correctly carried out at the correct time…<br />Regulatory requirement…<br />3<br />
  4. 4. Good Laboratory Practice-Documentation<br />WHAT IF I DON’T DOCUMENT???<br />Experimental data are lost…<br /> Complete record is not made…<br /> Lost/ Incomplete documentmay invalidate study…<br /> Impossible to justify as the usual believe is…<br />Regulatory action…<br />No record means procedure not done...<br />4<br />
  5. 5. Good Laboratory Practice-Documentation<br />WHAT DO WE MEAN BY DOCUMENT?<br />Descriptive document…<br /> Results of original measurements, observations, and activities associated with the study which may be needed to verify and evaluate the study…<br /> Which will provide a picture of what actually happened during the course of an activity…<br /> Examples are: Raw Data in Laboratory Notebook, Logbook, <br />Forms, Project Binder/File,<br /> Paper Printout, Electronic Format, All type of records… <br />5<br />
  6. 6. Good Laboratory Practice-Documentation<br />DOCUMENTATION TYPE…<br />6<br />Handwritten <br />Documentation<br />Electronic Data <br />Capture <br />Entry Into<br />Electronic System<br />Transcription of<br />Paper Records<br />To Computer<br />Database<br />Copying Raw<br />Data<br />
  7. 7. Good Laboratory Practice-Documentation<br />WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?<br />Identifiable…<br /> Promptness…<br /> Accurateness…<br /> Legibility…<br />Signature and Date…<br />7<br />
  8. 8. Good Laboratory Practice-Documentation<br />WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?<br />Therefore the document should show:<br /> “What was done”…<br /> “How it was done”…<br /> “When the work was performed”…<br /> “Who performed the work”…<br />8<br />
  9. 9. Good Laboratory Practice-Documentation<br />HOW CAN I FULFILL THE REQUIREMENTS?<br />Record data <br /> Directly into the required format and not transcribed from a rough copy…<br /> Promptly…<br /> Accurately…<br /> Legibly…<br />Then…<br />Sign and date…<br />Note: Sign indicates who has performed the work and date identifies when the work was performed…<br />9<br />
  10. 10. Good Laboratory Practice-Documentation<br />WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?<br />Any correction made during and or latter recording should be explained for…<br /> Reason for correction…<br /> The signature of the individual making the correction…<br /> The date the correction was made…<br />10<br />
  11. 11. Good Laboratory Practice-Documentation<br />HOW CAN I FULFILL THE REQUIREMENTS? Contd..<br />Therefore, remember to…<br /> Make a single line through the error…<br /> Record the correct entry on the above or next to the original entry with the reason for correction…<br />Then Sign and date…<br />Note: Correction codes can be used to simplify the explanation but shall be clear to the third party…<br />11<br />
  12. 12. Good Laboratory Practice-Documentation<br />HOW CAN I FULFILL THE REQUIREMENTS? Contd..<br />PRACTICE THIS<br />276<br />Error in writing<br />275<br />SB 31-10-2006<br />Sign and Date<br />Correct Entry<br />Reason for Correction<br />AND NOT THIS<br />Over writing<br />276<br />Scribbling<br />276<br />12<br />
  13. 13. Good Laboratory Practice-Documentation<br />WHAT SHOULD I REMEMBER?<br /> Documentation… <br /> Paramount importance…<br /> All information blanks that require data input must be completed…<br /> Record data to its completeness…<br /> Never assume that something written in SOP or Protocol are not required to be documented…<br /> Always sign and date…<br /> Never indulge in Fraudulence…<br /> Follow company’s SOP on Good Documentation Practice at all time…<br /> Never discard original record…<br />13<br />
  14. 14. Good Laboratory Practice-Documentation<br />14<br />BOTTOM LINE…<br />Documentation Constitutes An Essential Part Of<br />The Quality Management System<br />Should show complete History of AUDIT TRAIL<br />
  15. 15. Good Laboratory Practice-Documentation<br />Thank You<br />15<br />