GMP correction in executed documents


(Dhaval Dilipbhai shah) #1

Is there any sop for correction in executed document? Like after completing batch review, COA is prepared where one auditor found error that need to be corrected by adding one parameter than how it is to be corrected?


(Ravi Kumar.Tummuri) #2

Dear dhavalshah,

greetings of the day !!!

corrections in executed documents like COA, Protocols, Reports. while reviewing we will prepare an Addendum report for typo errors / manual errors / addition or deletion of parameters. it will mentioned in SOP on SOP and it is acceptable by auditors.


(Dhaval Dilipbhai shah) #3

Dear sir,
Thanks for your guidance. Could we request how the addendum report will be prepared means what contents I need to add in


(Ravi Kumar.Tummuri) #4

i didn’t have any specific templet. But Errata / Addendum report will prepare with description (Title of document, Reference No. and the observation), existing document / sentence read on and revised document / sentence read as. i prepare like this and shown to customers / auditors. Main title should be mentioned as “Errata report for xxxxxxx” where xxxxxx is document name like APQR / Protocol / report etc.,


(Dhaval Dilipbhai shah) #5

Okay sir thank u very much