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Correction of Documentation Errors

 

  • Objective

To lay down a procedure for correcting the errors in documentation.

  • Scope

This Standard Operating Procedure is applicable for correction of all documentation error in written procedures (SOPs, Specifications, STPs, or TDs etc.) and records (Batch Manufacturing Records, Raw Data, Log Books, etc.)

  • Responsibility
    • Each employee shall be responsible to ensure the accuracy of his or her documentation
    • All Head of department or area supervisor / in-charge shall be responsible to ensure errors are corrected as per this SOP.
    • Head Quality Assurance shall be responsible for compliance of this SOP.
  • Abbreviations and Definitions

Written Procedure  :       It includes current operational Standard Operating Procedures  (SOPs), Specifications, Standard Test Procedures (STPs), General Test Procedures (GTPs), Product development Reports, Master Formula Cards, Master Formula Records (MFRs), Technical Directions, Batch Manufacturing Records (BMRs), Annexure, Formats, Protocols, Reports, Labels, Qualification and validation documents, Case Report Form, Check .Lists and other departmental documents etc.

Image result for documents correction

  • Procedure
    • Any entry error made in written procedures shall be corrected for wrong entry as per the following steps.
      • Strike it out with one single line, so that the original entry remains legible. Write justification for the correction, appropriately above or beside the strike out, e.g. if the cause of the error is typographical, write ‘Typographical Error’, etc.
      • Initial and write the date when the correction was made.
        • If the correction is made on a date after the date of the original entry it shall be corrected as mentioned above and countersigned and dated by the immediate senior personnel, e.g. entry of wrong weight, volume, calculations, date, etc.
      • Blank spaces are not permitted in any record. In the event an item in a record is not applicable, ‘NA’ shall be entered. In case of equipment or rooms not being used at a given time, write “Not Used” in space provided.
      • If any document has more than one copy, then any correction shall be done simultaneously in all copies, e.g. if a correction is done in the master copy of an SOP then simultaneously corrections shall also be done in all the controlled copies of the SOP.
        • Any correction done in SOPs, Specifications, STPs, or Technical Directions shall be countersigned by authorized Quality Assurance personnel.
      • Under no circumstances shall any artificial correction be used to correct an error (e.g. white fluid, labels, erasers, etc.).
      • No overwriting shall be practiced.
      • Not more than three corrections shall be permitted on a single page. In case of more than three corrections, whole page shall be strike diagonally; word “Cancelled” shall be written duly signed by IPQA.
      • For cancelled pages all documents (like Standard Operating Procedures (SOPs), Specifications, Standard Test Procedures (STPs), General Test Procedures (GTPs), Product development Reports, Master Formula Cards, Master Formula Records (MFRs), Technical Directions, Annexure, Formats, Protocols, Reports, Labels, Qualification and validation documents, Case Report Form, Check .Lists and other departmental documents etc.) other than BMR; entries shall be re-done starting from fresh page.
      • For cancelled page of BMR production shall submit request to QA for issuance of new page. Entries shall be re-done on new issued page. Cancelled pages shall be retained in BMR along with new page issued by QA.
      • For pages with multiple entries with signature and dates of different personnel’s this SOP shall not be applicable. For e.g. clinical research documents where subject signature are taken.
    • Forms and Records

Nil

  • Distributions
    • Master Copy – Documentation Cell (QA)
    • Controlled copies – Quality Control, Production, Store, Finished Goods Warehouse, Engineering, Human Resource Development,Regulatory Affairs.
  • History
Date Revision Number Reason for Revision
00 New SOP

 

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