We manufacturer our supplements strictly in compliance with the FDA’s current GMP (Good Manufacturing Practices) guidelines. In essence, GMP makes the supplement manufacturers responsible for adhering to a specific set of manufacturing processes, safety procedures, and packaging standards to ensure that dietary supplement labels are truthful and that actual dietary supplement contents match the contents on the Supplement Facts label and are not misleading – in any way.
The GMP regulations are set in place to guarantee to consumers that strength and potency claims and ingredients statements on Supplement Facts label panels are accurate. GMP also makes dietary supplement manufacturers responsible for reporting product quality problems.
Here is an example of the process that we go through in adhering to the FDA’s guidelines. Please read about the various areas of compliance and what each involves.
GMP Regulations and Compliance Management Expertise - Well respected, industry known Quality Management.
GMP CertificationOutt - Our Manufacturing facility has been FDA GMP certified since 2011.
NSF Certification - Our Manufacturing facility has been certified by the prestigious 3rd party NSF
Raw Materials Inspection and Testing - All raw materials tested for identity, strength, heavy metals, microbial contamination and other likely adulterants.
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.
Approval Processes - All ingredients/products approved by Quality unit separate and independent from Manufacturing.
Microbial Testing - Ingredients/products are tested to ensure no harmful pathogens are present and that bacteria, yeasts and molds are at normal, safe levels.
Batch Documentation - All batch production records and associated documents completed according to FDA requirements and maintained for 6 years.
Stability Testing - On-going stability testing of many products to ensure shelf stable and for expiration dating.
Ingredient Identity - Ingredients are tested to ensure correct identity using sophisticated analytical methods.
Specifications - Production of the supplement is performed against specifications for each product including raw material, in-process and finished product specifications.