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Good Manufacturing Practices

Good Manufacturing Practice (GMP) is a system that makes sure  products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in production that cannot be eliminated through checking of the final product.

APOLLO SUN's manufacturers are (GMP) compliant with United States Food and Drug Administration (U.S. FDA); 

APOLLO SUN's manufacturers also cooperate with Underwriters Laboratories (UL) for their dietary supplement manufacturing process. The purpose of the UL® (NBCP) is to assess the extent to which an organization conforms to the applicable regulations and/or standards regarding the products being manufactured.

All processes also follow Current Good Manufacturing Practices (CGMP) regulations and voluntary Natural Products Association (NPA) 

At APOLLO SUNwe believe in transparency and choose to share certificates of analysis with our customers to earn their trust and help them make informed purchasing decisions. 

Here is the manufacturing analysis from the most recent GMP inspection:

Area of Compliance What We Do
GMP Regulations and Compliance Management Expertise Well respected, industry known Quality Management.
FDA Inspection Facility visited with no observations.
GMP Certification NPA GMP Assured since 2000; UL Compliant
Assure Label All finished products meet label claims.
Raw materials inspection  All raw materials are checked for identity, strength, heavy metals, microbial contamination and other likely adulterants.
Raw material suppliers All raw material suppliers qualified prior to use.
Manufacturing procedures All standard operating procedures meet FDA GMP requirements
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, equipment surface swabs, etc.
Laboratories Extensive in-house labs – analytical chemistry, microbiology, physical and sensory checks
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 is used in processing 
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 Check Ingredients/products are checked for harmful pathogens as well as for bacteria, yeasts and molds 
Ingredient weighing The addition of each ingredient is checked 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 check for shelf stability and for expiration dating.
Ingredient identity All ingredients checked for correct identity using sophisticated analytical methods.
Clean facility Facility cleaned daily according to cleaning schedule.
Specifications All production is performed against extensive specifications for each product including raw material, in-process and finished product specifications.

 

 

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