NOW Meets Regulatory Requirements with Flying Colors

May 11, 2016

NOW has an outstanding record when it comes to meeting FDA requirements for natural product manufacturing. Plus we go beyond the requirements in order to meet your standards of excellence.

But it’s one thing to tell you this. It’s another to break it down and show you the details. Here’s our latest report on how we’re doing.

NOW Foods GMP Dietary Supplement Program Report

Area of Compliance What We Do
GMP Regulations and Compliance Management Expertise Well respected, industry known Quality Management.
FDA Inspection Facility last inspected in 2015 – no observations.
GMP Certification NPA GMP Certified since 2000; UL Certified in 2015.
Assure Label All finished products tested to ensure products meet label claims.
Raw materials inspection and testing All raw materials tested for identity, strength, heavy metals, microbial contamination and other likely adulterants.
Raw material suppliers All raw material suppliers qualified prior to use.
Adulterant testing All sports product ingredients, male product ingredients tested for steroids, active pharmaceutical ingredients (drugs). All milk proteins tested for melamine. All weight loss products tested for weight loss drugs.
Organic Products All organic products produced meet the USDA NOP Requirements and certified by NSF/QAI.
Manufacturing procedures All standard operating procedures meet FDA GMP requirements and are approved by Quality.
Quality Inspections All products inspected by Quality Control personnel at every stage of the manufacturing process.
Cross contamination prevention Quality procedures to prevent cross contamination and allergen contamination include separate warehousing, special air handling systems, physical separators, robust cleaning procedures, residue testing, equipment surface swabs, etc.
Laboratories Extensive in-house labs – analytical chemistry, microbiology, physical testing, sensory testing.
Sanitation Extensive sanitation procedures including Master Sanitation Schedules, pest control, etc.
Approval processes
All ingredients/products approved by Quality unit separate and independent from Manufacturing.
Calibrations All equipment calibrated to ensure proper and accurate operation.
Hazards control All processes have been assessed for potential hazards and controls implemented to prevent contamination at each step/stage of manufacturing.  These features include sieves and magnets to prevent contamination of ingredients/mixes and metal detection at step of processing and packaging.
Water purification Only high purity water that is regularly monitored and tested is used in processing purified and tested.
Analytical methods
Only scientifically valid analytical methods to determine identity, measure strength and detect contamination are used.  Highly experienced and qualified senior scientists ensure methods are appropriate for their intended use.
Microbial testing
Ingredients/products are tested to ensure no harmful pathogens are present and that  bacteria, yeasts and molds are at normal, safe levels.
Ingredient weighing
The addition of each ingredient is verified by a second person to ensure accuracy and safety.
Batch documentation All batch production records and associated documents completed according to FDA requirements and maintained for 6 years.
Retained samples
Samples of all products, ingredients and in-process steps maintained for 6 years.
Stability testing
On-going stability testing of many products to ensure shelf stable and for expiration dating.
Ingredient identity
All ingredients tested to ensure correct identity using sophisticated analytical methods.
Clean facility
Facility cleaned daily according to cleaning schedule.
All production is performed against extensive specifications for each product including raw material, in-process and finished product specifications.