How to correct effective GMP documents (DRF)

Document correction is correction of any documentation error in written procedure’s and records, it may be typographical errors, wrong entries, rectification or missing information etc. 

Typographical errors: The term includes errors either mechanical failure like pressing of wrong key during typing, simple duplication, omission, transposition, or substitution of a small number of characters but excludes errors of ignorance or in case of hand written records to includes wrong entry.

1. Rectification of Master document/ previously approved document and filled documents is allowed with proper correction and justification is duly approved as per requirement of the written procedure, at the time of review of any documents, if any correction is observed/required, concerned person of the department shall raise a request for "Document Rectification" to correct the error after gating approval from quality units.
2. The details of correction, concerned person shall forward "Document Rectification" to HOD of the concerned department, who shall verify and justify the reason for the correction with assurance of all linked documents, which require rectification, are adequately identified and form shall be forwarded to Quality unit for approval.
   
3. If document rectification is approved, corrections shall be made in original documents (like MASTERS or executed documents by concerned department and shall be verified by quality unit. Reference number of document rectification (DRF) or a copy of approved DRF shall be filed along with original document, where rectification has been made and a record shall be made for future reference.
   
4. If any document has more than one copy (controlled, reference and approved copies) then same copies shall be retrieved & reissued after rectification / re-issuance record shall be made if applicable, in original document.The permanent changes shall be incorporated into the master documents through revision, which shall be handled through the change control procedure.
   
5. In case, entry made in any record / format / logbook / document which is to be corrected, following steps shall be followed for correction of wrong entry.
   

• Strike out the entry with one single line with initials signature  and date of correction ensuring that the original entry remains legible.
• If the rectification is related to date or time of process / analysis, weights, volumes, calculations, etc. the rectification shall be countersigned by Head of the concerned department.

When an entire paragraph is to be deleted from sequential record for correction then following steps shall be followed:

•  Strike it out with one single line, so that the original entry remains legible.
• Write the reason for deletion, above or beside the strikeout. Countersigned the correction with date. If the correction is being made on a date after the date of initial entry, it shall be corrected as mentioned above and in addition countersigned by the immediate senior.
  
  Note: The rectification notice shall be sent to Regulatory Affairs, in case the document is submitted for filing / registration. Intimation shall also be provided to Contract Giver / Regulatory agencies.