Grade - Active
Posted Yesterday, 08:20 PM
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?
Edited by twillsedp, Yesterday, 08:21 PM.
SQFconsultant
Posted Yesterday, 09:01 PM
There are no specific requirements as to #.
All the Best,
All Rights Reserved,
Without Prejudice,
Glenn Oster.
Glenn Oster Consulting, LLC
SQF System Development | Internal Auditor Training | eConsultant
http://glennoster.website3.me/ -- 774.563.6161
Accepting RLUSD, XRP, XLM, XDC & HBAR
Private Telegram Page...
MVI Digital Warrior
|
Thanked by 1 Member:
|
|
Grade - FIFSQN
Posted Today, 02:37 AM
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
IFSQN Implementation Packages, helping sites achieve food safety certification since 2009:
Practical Internal Auditor Training for Food Operations - Available via the previous webinar recording. Fantastic value at $97/per person, but don’t take our word for it, read the Customer Reviews here
Grade - FIFSQN
Posted Today, 06:23 AM
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.
************************************************
25 years in food. And it never gets easier.
|
Thanked by 1 Member:
|
|
Grade - Active
Posted Today, 12:19 PM
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.
Edited by twill, Today, 12:19 PM.
0 members, 1 guests, 0 anonymous users
