SOP FOR CORRECTION OF DOCUMENTATION ERRORS

1.0       OBJECTIVE

           To lay down the procedure for correction of errors in documentation.

2.0       SCOPE

            This SOP is applicable for errors made during the documentation entry in all functional areas.

  • RESPONSIBILITY
  • All  member of staff in the organization shall be responsible for:
    • Making error free documentation entry.
    • Correcting the documentation errors if any as per the laid down procedure.

4.0     ACCOUNTABILITY

Head- Quality Assurance

  •      PROCEDURE:
    • Any error made or detected during the documentation shall be corrected in such a manner the original entry is not lost.
    • Do not overwrite on the original entry.
    • Strike off the wrong entry with a single line in such a way that it permits the reading of the original information. For example, 286.38 is to be corrected as 286.36, then, it shall be cut as 286.38 and corrected as 286.36.
    • Put initial and date near the stroked off entry.

5.5       Do the alteration accordingly and state the reason where appropriate near the stroked off area in short.

5.6       No correction fluid, eraser, label, etc. shall be used for the alteration.

5.7       Put an indicator mark such as *, #, etc. if there is no space for explanation and mention reason at an available space on the same page.

6.0       TRAINING

Trainer   : Head – Quality Assurance

            Trainees: Staff of all the departments

7.0         DISTRIBUTION

Master Copy                      :          Quality Assurance

              Controlled Copy                   :           Quality Assurance

  •        ATTACHMENT

              Nil

9.0     REFERENCES         

In-house

10.0    ABBREVIATION

Abbreviation Extended Form
    EG Engineering
SOP Standard Operating Procedure
QA Quality Assurance
WH Warehouse
NA Not Applicable
MB Microbiology

11.0    REVISION HISTORY OF CHANGE

Sr. No. Date Revision Details Revision No.

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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