Good Manufacturing Practices

RAW MATERIALS:
The raw materials used in all of our formulations meet or exceed GMP standards.
- There is no mold, bacteria or other biological contaminants.
- There are no harmful levels of heavy metals.
- Truth and Integrity of each ingredient is double checked and verified.
Manufacturing Facilities:
- Cleanliness according to FDA and CDC guidelines.
- Free of contaminants
- Free of unwanted Microbes
Finished Product:
- Tested and verified each product meets or exceeds product specifications
We are our own customers which helps us create and maintain a product selection that is safe, fun and effective.
More about our GMP and Quality Standards:
GMP:
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 SUN we 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 are 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 every step and stage of the manufacturing process. These features include sieves and magnets to prevent contamination of the ingredients and mixes including metal detection at each 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 are used to determine the identity, measured strength and contamination detection. Highly experienced and qualified senior scientists ensure our methods are appropriate for their intended use. |
Microbial Check | Ingredients and finished 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 are maintained for 6 years. |
Stability | frequent checks for shelf stability and expiration dating. |
Ingredient identity | All ingredients checked for correct identity using sophisticated analytical methods. |
Clean facility | Facility cleaned daily according to cleaning schedule and newly implemented CDC guidelines. |
Specifications | All production is performed against extensive specifications for each product including raw material, in-process and finished product specifications. |