Batch and Master Batch Record Template for Pharmaceutical Industry

[unique_dominant]

hello every body
i need templates or forms for batch record and master batch record for pharmaceutical industry
thanks in advance

 

[Stijloor]

Hello everybody,

I need templates or forms for batch record and master batch record for pharmaceutical industry.

Thanks in advance.

Can someone help this new Member?

Thank you.

Stijloor.

 

[harry]

This is a simple example from the web.


.

 

[unique_dominant]

many thanx, i really appreciate
but sorry i think i mean "Batch production and control records" template or form
that composed of
-manufacturing order
-master formula and methods(procedures)
-precautions
-packaging instructions etc.

many thanx in advance

 

[kengy Donina]

hello..
i just want to ask help..
if you have a file of example of master packaging procedure form,
Please.. can i have a copy? i just really need it..
thank you

 

[v9991]

Have a look at following reference, pg 74,
(broken link removed)
hope this helps as starting point.
Indicate any specific queries/areas you want clarifications on.

 

[shyamk]

What is the difference between the Master formula record and Batch manufacturing record?
From what I understand that when the master formula record is issued to the production department and the product is manufactured using it then it become BMR. Is this correct?

 

[v9991]

What is the difference between the Master formula record and Batch manufacturing record?
From what I understand that when the master formula record is issued to the production department and the product is manufactured using it then it become BMR. Is this correct?

No,
BMR is specific to a manufacturing location, batch size; IT contains operational and specific-steps to executed .It is issued to production, for execution and recording the details & evidence of compliance!!! it derived based on the master formula record.

MPR contains a recipe/formula and overview of the process steps. It is more of a process definition document; this is the basis to derive the BMR.
(broken link removed)

Sec. 226.102 Master-formula and batch-production records

 

[shyamk]

thank you for the quick reply. This really helped me understand the difference between them

 

[kamani7208]

I need BMR template for pharmaceutical excipients packaging in Drums