Batch record supersedes all other instructions

[monophots]

Hi all,

This is kind of an interesting question we had that got raised the other day.

Our mfg site uses area specific WIs that are not specific to a product/PN, think of area clearance or setup procedures associated with equipment. Many products' batch records call on these area specific instructions in order to help the product specific batch record make the product. I've always taken for granted that any parameters or specifics to the product that are stated in the batch record would supersede anything one of these area specific instructions states. Is this true? Is it stated in CFR somewhere that this is the default succession, if so where? Or should our firm have an SOP stating this succession hierarchy?

Any help that can be offered is greatly appreciated in advance.

 

[pkost]

I'm not aware of anything being defined by the regulation or any standard. You would have to document it in your system otherwise you are at risk of a non conformance as it would likely be seen as a contradiction. Depending on what it is specifically then you may want to consider additional controls as the risk of people following the normal way of working instead of an exception is high

 

[Ajit Basrur]

Hi all,

This is kind of an interesting question we had that got raised the other day.

Our mfg site uses area specific WIs that are not specific to a product/PN, think of area clearance or setup procedures associated with equipment. Many products' batch records call on these area specific instructions in order to help the product specific batch record make the product. I've always taken for granted that any parameters or specifics to the product that are stated in the batch record would supersede anything one of these area specific instructions states. Is this true? Is it stated in CFR somewhere that this is the default succession, if so where? Or should our firm have an SOP stating this succession hierarchy?

Any help that can be offered is greatly appreciated in advance.

Instead of going into that sort of hierarchy, I would suggest to have generic WIs applicable for all products, with a NOTE to refer to product specific batch records for those specific instructions.

Having two sets of instructions may cause confusion in operators and technicians. I had similar situation in my past role, and affected the validated parameters. Therefore, as part of CAPA, we decided to have one set of requirements and identified its place in the Batch Records only.