2 replies to this topic

[lavalienteQA]

Hi All, 

 

Still stumped here- 

 

 

2.3.1.5 The process flows for all new and existing manufacturing processes shall be designed to ensure that product is manufactured according to approved product formulations and to prevent cross-contamination.

 

 

 

To me- Process flows means to have the following- Product Formulation and Realization SOP that details process for all current product and new product

 

 

Does this sound correct to you all? Am i Missing something? 

[OrRedFood]

I'm following this topic.  I think that the process flow diagrams are part of what the code is asking for. The flow chart steps and the equipment must be capable of meeting your desired specifications and prevent cross contamination (i.e. Cleaning ability, product lines running over another, etc.).  

[Gelato Quality Lead]

I agree with the above comment about having specific process flow diagrams. They might also want records of process parameters. Example: pasteurization must occur for x number of seconds at x degrees. They would want to see a record that the required time and temperature were actually met.