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Batch and Master Batch Record Template for Pharmaceutical Industry


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Related Topic Tags
pharmaceuticals and pharmaceutical industry, forms and templates (general), batch manufacturing records
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  Post Number #1  
Old 11th October 2010, 03:29 PM
unique_dominant

 
 
Total Posts: 2
Thank You! Batch and Master Batch Record Template for Pharmaceutical Industry

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

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  Post Number #2  
Old 12th October 2010, 02:33 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,044
Re: Batch and Master Batch Record Template for Pharmaceutical Industry

Quote:
In Reply to Parent Post by unique_dominant View Post

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.
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  Post Number #3  
Old 12th October 2010, 02:57 AM
harry

 
 
Total Posts: 6,273
Re: Batch and Master Batch Record Template for Pharmaceutical Industry

This is a simple example from the web.


.
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf batch record sample.PDF (18.6 KB, 1188 views)
Thank You to harry for your informative Post and/or Attachment!
  Post Number #4  
Old 12th October 2010, 08:27 AM
unique_dominant

 
 
Total Posts: 2
Re: Batch and Master Batch Record Template for Pharmaceutical Industry

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
  Post Number #5  
Old 7th March 2011, 09:51 AM
kengy Donina

 
 
Total Posts: 1
Re: Batch and Master Batch Record Template for Pharmaceutical Industry

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
  Post Number #6  
Old 8th March 2011, 09:47 PM
v9991

 
 
Total Posts: 853
Let Me Help You Re: Batch and Master Batch Record Template for Pharmaceutical Industry

Have a look at following reference, pg 74,
http://www.who.int/vaccines-document...DF/www9651.pdf
hope this helps as starting point.
Indicate any specific queries/areas you want clarifications on.
Thanks to v9991 for your informative Post and/or Attachment!
  Post Number #7  
Old 28th November 2014, 01:41 AM
shyamk

 
 
Total Posts: 2
Re: Batch and Master Batch Record Template for Pharmaceutical Industry

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?
  Post Number #8  
Old 28th November 2014, 06:51 AM
v9991

 
 
Total Posts: 853
Look! Re: Batch and Master Batch Record Template for Pharmaceutical Industry

Quote:
In Reply to Parent Post by shyamk View Post

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.
Guide to Master Formulae

Sec. 226.102 Master-formula and batch-production records
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