Scribd
Upload
155 views1 page

Good Documentation Practices

Good Documentation Practices (GDP) in Pharmaceuticals outlines standards for documentation entries, corrections, and cancellations. All entries must be made in indelible black ink and legibly. Verification is done in blue ink and green ink is used only for specific documents. Do not leave columns unfilled and use standard date and time formats. If pages are left blank, draw a line across and mark as cancelled. Entire page or paragraph cancellations require counter-signature. Correct errors by crossing out and rewriting accurately near the original with initials, signature, and date. Later corrections require counter-signature and date.

Uploaded by

Dharmesh Patel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
155 views1 page

Good Documentation Practices

Good Documentation Practices (GDP) in Pharmaceuticals outlines standards for documentation entries, corrections, and cancellations. All entries must be made in indelible black ink and legibly. Verification is done in blue ink and green ink is used only for specific documents. Do not leave columns unfilled and use standard date and time formats. If pages are left blank, draw a line across and mark as cancelled. Entire page or paragraph cancellations require counter-signature. Correct errors by crossing out and rewriting accurately near the original with initials, signature, and date. Later corrections require counter-signature and date.

Uploaded by

Dharmesh Patel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 1

Good Documentation Practices (GDP) in Pharmaceuticals

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

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

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

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 ‘---‘.

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

While issuing documents and in other record books the date should expressed as

DD-MM-YY or DD.MM.YY or DD/MM/YY.

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


DD.MM.YYYY or DD/MM/YYYY.

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.

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


required.

No pencil entries are allowed.

Do not use correction fluid in any of the documents

All personnel shall avoid errors during data entry.

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

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.

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

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.

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.

Cross out with a line

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

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

You might also like