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FDA/SQF requirements for Finished Product Testing?


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#1 Sarahb3339

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Posted 06 April 2019 - 04:18 PM

Good morning, 

 

Our facility is a dietary supplement manufacturing company and we are SQF 2 certified.  I have a question regarding finished product testing /shelf life.

 

The FDA visited us and stated that we needed to verify finished product testing to ensure that it is meeting the claims of what is on the supplement fact panel.

 

Only 2 of my ingredients have a percent daily value.  The rest do not and some are combined into a "matrix" with no percent daily value.  How would I conduct finished product testing?

 

Do I only have to confirm the daily value claims?  Also, micro and metals testing?  The agent was speaking as if we only needed to confirm the % daily values.



#2 Charles.C

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Posted 06 April 2019 - 07:34 PM

Good morning, 

 

Our facility is a dietary supplement manufacturing company and we are SQF 2 certified.  I have a question regarding finished product testing /shelf life.  The FDA visited us and stated that we needed to verify finished product testing to ensure that it is meeting the claims of what is on the supplement fact panel.  Only 2 of my ingredients have a percent daily value.  The rest do not and some are combined into a "matrix" with no percent daily value.  How would I conduct finished product testing?  Do I only have to confirm the daily value claims?  Also, micro and metals testing?  The agent was speaking as if we only needed to confirm the % daily values.

 

Please avoid posting duplicate topics. It causes confusion.

 

afaik, SQF2 no longer exists.


Kind Regards,

 

Charles.C


#3 Sarahb3339

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Posted 06 April 2019 - 07:40 PM

SQF version 8.0, my apologies.  Does anyone have any information on the finished product testing ?  Just trying to clarify exactly what the FDA/SQF wants regarding my question . 



#4 majoy

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Posted 09 April 2019 - 02:49 PM

SQF version 8.0, my apologies.  Does anyone have any information on the finished product testing ?  Just trying to clarify exactly what the FDA/SQF wants regarding my question . 

 

FDA and SQF are 2 different entities. Therefore, you should look into each of their requirement for your compliance.

 

For SQF, you set the finished product specifications and you conduct testing based on that specifications.

 

2.3.1 Product Development and Realization

2.3.1.1 The methods and responsibility for designing, developing and converting product concepts to commercial realization shall be documented and implemented.
2.3.1.2 Product formulation, manufacturing processes and the fulfillment of product requirements shall be validated by site trials, shelf life trials and product testing.
2.3.1.3 Shelf life trials where necessary shall be conducted to establish and validate a product’s:
i. Handling, storage requirements including the establishment of “use by” or “best before dates”;
ii. Microbiological criteria; and
iii. Consumer preparation, storage and handling requirements

 

2.5.4 Product Sampling, Inspection and Analysis

2.5.4.1 The methods, responsibility and criteria for sampling, inspecting and/or analyzing raw materials, finished product and work in progress shall be documented and implemented. The methods applied shall ensure:
i. Inspections and analyses are completed at regular intervals as required and to agreed specification and legal requirements;

 

Another is it must meet the regulation of the country of sale,

2.4.1 Food Legislation (Mandatory)

2.4.1.1 The site shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of use or sale. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, packaging, product description, net weights, nutritional, allergen and additive labeling, labeling of identify preserved foods, any other criteria listed under food legislation, and to relevant established industry codes of practice.

 

So testing parameters is really to your company & products , the customer requirements, and the regulations that exists on your products.


"Whatever you do, do it well..." - Walt Disney


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#5 Charles.C

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Posted 10 April 2019 - 12:48 AM

From a SQF POV, does the OP have a connection with food safety ?. I think not ?.

 

And possibly also for several of the elements in Post 4.

 

I note the Guidance comments -

 

The supplier must have a procedure in place to ensure the safety of products escalated from bench/pilot scale production to full commercial production

 

.


Kind Regards,

 

Charles.C





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