Product Development and Realization

Are there specific requirements for the number of validation trials following a change in product formulation compared to those required for a new product development? What factors determine the appropriate number of trials in each case?

There are no specific requirements as to #.

Hi twill,

As Glenn has posted, there are no specific requirements regarding the number of trials.

The amount of trials and level of validation would normally be dependent on the degree of reformulation and level of risk associated with the change. 

For significant changes I would expect to see three validation/shelf life trials, for minor changes one may be acceptable if you justify and document that the change is considered to be very low risk.

Kind regards,

Tony

I assume you mean cook and micro validation?  I'm not an SQF auditor but the approach I always took with my process teams was that three trials for a new cook programme were needed.  If it was an old cook programme but a new marinade on a same cut of meat or vegetable, then I was more chilled out about it.  Micro still 3x because changes in spices etc change loading but not datalogging or do one for due diligence if you're being ultra cautious.

Hi twill,

 

As Glenn has posted, there are no specific requirements regarding the number of trials.

 

The amount of trials and level of validation would normally be dependent on the degree of reformulation and level of risk associated with the change. 

 

For significant changes I would expect to see three validation/shelf life trials, for minor changes one may be acceptable if you justify and document that the change is considered to be very low risk.

 

Kind regards,

Tony

Thanks for your response, Tony.

It's a minor change to the formulation to remove a sweetener, so the risk should be low. That said, I am concerned about how it may affect shelf life.