Good Documentation Practices (GDP) in Pharmaceuticals

Good Documentation Practices (GDP) in Pharmaceuticals

1.  All documentation entries shall be made with indelible black ink in clear and legible handwriting.

2.  Verification of the Document made by QA by using indelible blue ink.

3.  Green ink shall be used only by QA for issuance of BMR / BPR.

4.  Do not leave any column in the record / document unfilled. If any column in a record document is not      applicable, write “N.A”. If no comments write nil or put ‘---‘.

5.  Time should be expressed as HH.MM i.e. 2 pm should be recorded as 14.00 hrs.

6.  While issuing documents and in other record books the date should expressed as DD-MM-YY or  DD.MM.YY or DD/MM/YY.

7.  While approving document the date should be expressed as DD-MM-YYYY or DD.MM.YYYY or DD/MM/YYYY.

8.  If any page(s) left blank, draw a line across the page from left top to right bottom of the page and write “CANCELLED” / “N.A.” (Not applicable) across the page and sign with date.

9.  If an entire page / paragraph is to be cancelled from a document, QA counter sign is required.

10.  No pencil entries are allowed.

11.  Do not use correction fluid in any of the documents

12.  All personnel shall avoid errors during data entry.

13.  In case an entry error is occurred, the same shall be corrected as described below.

14.  Do not overwrite the wrong entries. Cross it out with a line permitting the reading of original entry. Clearly write the correct entry near the cross out.

15.  Initial / Sign and put date, on which the correction was made. Wherever appropriate, the reasons for correction shall be recorded.

16.  If the correction is made on a date after the date of original entry, it must be corrected as mentioned above and counter signed and dated by the supervisor or QA.

17.  If an entire line / paragraph / page to be deleted from a sequential record (e.g. log book or stock card) the following steps to be taken.

i)  Cross out with a line

ii)  Write a comment explaining the reason for deletion near the cross out.

iii)  Initial / sign and put the date, on which the correction was made.