Batch Record Standardization Process Advice

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kevcos

All, Our plant has three very different manufacturing processes: API, Human Health Secondary Manufacturing and Animal Health Secondary Manufacturing. Also like most Pharma plants today we have transferred many products in from other sites. All of these products have wide variations in the style of the paper batch record that is being used. As we lean out our plant and reduce our labor force these style changes are problematic.

I have been asked to lead a cross product group to develop a single set of batch record rules that will remove a significant portion of this unique style. I am developing my plan now and wanted to know if there are others out there who have done this exercise before and if they could provide any advice or publications that I could purchase that would help me in this project.

Thanks for you help.
 
P

Polly Pure Bread

Hi,

I think folks can better recommend great advices if you can post the existing style you mentioned or give more information about your batch record. From there, folks can assess the situation and identify possible solutions to meet yourspecific requirement. Are you planning to go for electronic batch records or maintain the paper based system?
 
K

kevcos

Mark, Thanks for the reply. I agree that each aspect of the batch record will need to have analysis and recommendations but at this time there are hundreds of areas in scope. I will provide one high level example to provide a flavor.

The basis requirement is for documenting a series of challenges to be certain that the portable equipment for the line has been set up properly. An example would be an in-line label printer that prints expiration data. A different example would be a metal detector.

Style #1 – In the batch record have a Pass box and a Fail box. The operator must check one box and sign. There is room for explanation of any Fail box checks.

Style #2 – A line for a signature of each challenge with the assumption that if the challenge failed the operator would adjust the device until the challenge would be cleared.

Style #3 – A single box to indicate that all challenges have been completed successfully

Style #4 – A few boxes that the operator must put in the challenge value as well as their signature.

The initial reaction is that each of these styles is critical for different types of challenges. But as we talk this thru I find there is more style preference than GMP rational. The projects hope is that a) we can come to a default agreement and b) we can identify any exceptions to the rule that provide specifics of what would be allowed by and expectation.

While I am indeed interested in how to solve the above problem I am more looking for advice on a process to harmonize hundreds of these. I believe the key will be to have some definitive external standard that we can focus on to move the multiple preferences to a single standard.
 
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Polly Pure Bread

I’m not Mark.:)

Can anyone help out concerning batch record standardization process?
 
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