Jump to content

  • Quick Navigation
Photo
- - - - -

Research and Development Laboratory


  • You cannot start a new topic
  • Please log in to reply
3 replies to this topic

#1 svnh.bell

svnh.bell

    Grade - AIFSQN

  • IFSQN Associate
  • 31 posts
  • 2 thanks
0
Neutral

  • Earth
    Earth

Posted 31 January 2017 - 07:41 PM

Hi all - I am looking for some resources and clarification on what regulations/inspections our research lab is subject to (beyond GLP). We have production and research facilities under one roof - but are clearly designated. We product food, nutritional supplement, and cosmetic ingredients. If the Dept of Ag (acting as FDA in my state) were to come in for a surprise inspection, are they able to inspect our research laboratory? Does the laboratory need to be designated as ONLY food-grade? 

 

Any feedback would be much appreciated! Thank you!! 


  • 0

#2 FurFarmandFork

FurFarmandFork

    QA Manager/FS Blogger

  • IFSQN Principal
  • 530 posts
  • 256 thanks
37
Excellent

  • United States
    United States
  • Gender:Male
  • Location:USA

Posted 31 January 2017 - 11:48 PM

If materials that go into your lab then enter the production floor and impact commerce, then it needs to be at the same standard because what happens there could implicate your products. FDA/State can only inspect areas that are used to manufacture, prepare, package, ship, or store food. So if you truly only use it for R&D and it's separated by GMP's, equipment, etc., they have no business there. If you're occasionally using it to prep small batches or introduce new ingredients, then they have the authority to inspect to the same standard.

 

If on the other hand the lab only creates samples etc., then keep them clearly separated just like you would a lunchroom. In general, because R&D samples could be sent around as freebies, I would ask the R&D area to adhere to FDA Food Code. That way you can say that while they don't have all the paperwork, random stuff like brittle plastics, and other manufacturing requirements (verification of sanitation, etc.), they have to hold themselves to the same standard as a grocery store or restaurant, which I would consider a reasonable standard to meet for an R&D lab.


  • 0

QA Manager and food safety blogger in Oregon, USA.

 

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

Subscribe to have one post per week delivered straight to your inbox.

 


Thanked by 1 Member:

#3 svnh.bell

svnh.bell

    Grade - AIFSQN

  • IFSQN Associate
  • 31 posts
  • 2 thanks
0
Neutral

  • Earth
    Earth

Posted 01 February 2017 - 02:00 PM

Thank you so much for the feedback Earth 20, the helps immensely. I have another question if you are willing to entertain...

 

Our company produces nanodispersions and emulsions that are used in food, beverage, nutritional supplement and cosmetic markets. Does the R&D lab need to be strictly "food grade"? Are we able to prep samples of cosmetics in the same area? If we had a robust laboratory manual detailing keeping the non-food grade and food grade items distinguished from each other, never mixed, but in the same area - would that suffice? 

 

Thanks! 


  • 0

#4 FurFarmandFork

FurFarmandFork

    QA Manager/FS Blogger

  • IFSQN Principal
  • 530 posts
  • 256 thanks
37
Excellent

  • United States
    United States
  • Gender:Male
  • Location:USA

Posted 01 February 2017 - 04:24 PM

The first question again is when you say "prep samples", does this ever mean salable/distributable product? If it does then you're on the same level as your manufacturing facility as stated above. If materials from the lab are never sold or introduced to your plant, and are used solely for experimentation, you really have no standard you have to meet other than to keep your employees and testers of these samples safe, and you have no "requirements".

 

If you wanted to follow my advice and stick to the FDA food code for your R&D lab to make sure that your samples are held to the same standard as a retail store, non-food grade substances would be defined as "Poisonous or toxic materials" in FDA food code, and your responsibilities would be:

 

See section 7-2 of the 2013 FDA food code: http://www.fda.gov/d...e/UCM374510.pdf

 

Only those POISONOUS OR TOXIC MATERIALS that are required for the operation and maintenance of a FOOD ESTABLISHMENT, such as for the cleaning and SANITIZING of EQUIPMENT and UTENSILS and the control of insects and rodents, shall be allowed in a FOOD ESTABLISHMENT

 

 

If you are preparing cosmetics or "items not intended to be ingested", then you aren't holding the area to the standard of a "food establishment", and instead as a multi-purpose room. The requirements for separation and product safety are only as strict as your intended scope of distribution of these samples. If it's in house only, do whatever you want as long as your employees are kept safe by your separation procedures . If it leaves the building, I would not recommend combining those functions any more than I would combine a pathogen testing lab with a sensory lab, or use my mixing bowls at home to mix fertilizer or epoxy.

 

A true laboratory by most standards doesn't permit eating to keep employees safe (OSHA, etc.), a "Test Kitchen" should really be that, a kitchen intended for preparing products that are safe to eat. Doing both in the same area is not best practice, so do what you can to eliminate risk and know that it's a potential point of improvement in your facility.


  • 0

QA Manager and food safety blogger in Oregon, USA.

 

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

Subscribe to have one post per week delivered straight to your inbox.

 





0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users