BMR in soft copy

GOOD DOCUMENTATION PRACTICE (GDocP)
1

Hi Everyone,

I need some suggestion regarding the preparation, online entries, operator signature , maintenance & retrieval of BMR in soft copy .

Is it advisable since i have seen bmr entered & maintained as hard copy.

In case during audit, whether they will go for any system validation w.r.t this procedure.

Kindly can any one suggest

Thanks in advance

2

There are Golden rules how to use a BMR
-Always print original copy.(A hard copy on a clean white paper.The reason is photo copying might cause some problems in viewing and if there are any mistakes in previous versions of BMR they are copied the same way in a Photocopy.)

-You have to carry the BMR at the production site at the spot.

-Always record data immediately.

-Always use Black ink.(There are many views about usage of Black or Blue)–If auditors insist sign with a Blue ink so that its a proof that its not photo copied.

-Always mention date, Time and Signature.

-If any error is made in writing, STIKE ON THAT ERROR in a single line, Make a signature on top of that and next to that Note the reading.

The Chinese proverb says “Faint ink is always better than great memory”.

During the audit , if the auditor feels that particular batch has to be reviewed, he might ask you to retrieve the hard copy for examining that. He might compare the values and limits with the Process Validation document of the same product if its necessary.There is no hard and fast rule that the Auditor might compare or check with Validation process. These days Auditors are certainly interested in knowing the Cleaning Validation protocol and Alert limits of that particular batch if you have a Campaign Production where multiple products are manufactured at same facility by using one or more common Process Equipments.Keep them ready too.

Always file the BMR with BPR and all the necessary documents of batch release in a special cover, Number that, Name that and keep it in a shelf. When auditor asks you can get it easily and its a good way to keep documents.

3

Hi

I need some suggestion regarding the preparation, online entries, operator signature , maintenance & retrieval of BMR in soft copy .
Ans- Soft copy always better for reliability ,uniformity , errors & controls
Is it advisable since i have seen bmr entered & maintained as hard copy.
Ans- Yes
In case during audit, whether they will go for any system validation w.r.t this procedure.
Ans- Yes

With this system you can build more confidence / assurance