Arkworld Labs & Manufacturing

At Arkworld Manufacturing Facilities our total quality management program exceeds all US government regulations and strictly adheres to FDA Pharmaceutical standards of current Good Manufacturing Practices (cGMP). In the dieting supplement industry quality standards vary dramatically from one manufacturer to another.

Arkworld's product quality standards are in alignment with FDA drug standards. Audited by the FDA our processes substantially exceed new proposed GMPs for supplements and meet all critical requirements for drug level production.

Arkworld only works with the most reliable raw material suppliers approved through a vendor audit process. Each delivery of ingredients is quarantined until the material is laboratory tested to verify its identification, quality level and safety.

Additional tests are performed to determine various physical characteristics, to ensure proper product manufacturing standards can be achieved.

A complete microbial laboratory is equipped for testing bacterial levels and the presence of pathogens. Strict US Pharmacopoeia Methodology is used and good lab practices are followed.

Arkworld manufacturers are involved in quality processing related associations and certification groups, which means they are committed to the highest quality standards.

• Registered FDA Manufacturer
• FDA Lableler Code assigned
• FDA audited and inspected
• Therapeutic Goods Administration (TGA) Certification (Australian Government)
• Member of American Society for Quality (ASQ)
• Member of American Chemical Society (ACS)
• Member of American Association for Advancement of Science (AAAS)
• Complient with Certified Organic Processing
  standards
• Kosher audited and compliant.

Facts about Arkworld Labs & Manufacturing

Arkworld's manufacturing is composed of a team of people with decades of knowledge in the dietary supplement and pharmaceutical industries.

• Poor manufacturing can destroy great science, therefore ARKWORLD chose a manufacturing facility that voluntarily meets cGMP for pharmaceutical-grade products…much higher than the law requires and far-surpassing the standards followed by most nutritional product manufacturers.
• To adhere to these exacting standards, Arkworld's manufacturer tests the raw ingredients, tests the product during manufacturing and tests everything once again before it goes out the door.
• Our manufacturer’s Quality Assurance Team meticulously tracks every detail, from the sophisticated testing and evaluation of raw materials, to what happens to the products during shipping and storage.

Research and discovery are the driving forces behind great ideas and great products. Staying on the cutting edge of nutrition involves a tremendous amount of foresight. Our scientific support team has that foresight as they comprise a select group with extensive experience, not only in the pharmaceutical industry, but also as natural product chemists, patent holders, and collaborating researchers with major Universities and Government Agencies.

• Our manufacturing facility was founded by a management team with decades of experience in developing and operating sophisticated pharmaceutical grade facilities for the manufacturing of dietary supplements. They intimately understand the physical and chemical properties of the natural components used in this type of manufacturing.

• ARKWORLD products contain only the most reliable and proven ingredients. At our manufacturer, each delivery of ingredients is quarantined until the material is laboratory tested to verify its identification, quality level and safety. Additional tests are performed to determine particle size, density and moisture content. A complete microbial laboratory is equipped for testing bacterial levels and the presence of pathogens.

• With the dietary supplement industry becoming more sophisticated and moving away from the “Home Remedy” type of products, a scientific approach to product design, formulation, and standardization is required to effectively design new products for this maturing industry. Identifying active ingredients, marker compounds, and determining the overall effectiveness of single and combination formulas is an important function performed by the scientific team at our manufacturer. The effectiveness of blending and processing ingredients during manufacturing has a strong correlation to the physical characteristics of the powders and affects the consistency and quality of the finished product.

• Once the formula and specifications are finalized, the raw materials are ordered based on set scientific standards. Before any raw materials are permitted to enter production, ingredient specifications are verified through appropriate laboratory testing.

This combined experience enables the Arkworld manufacturer to successfully meet the demands and challenges in the Dietary Supplement market and regulatory environment.

This experience extends to all phases of the organization, including manufacturing, quality assurance, purchasing, finance, product development, laboratory testing and analysis, pharmaceutical quality research, customer service, sales and marketing.

• The scientific support team consists of three PhDs with broad pharmaceutical industry experience as well as phytomedicinal expertise.

• As the Dietary Supplement industry continues to rapidly grow, the best insurance against consumer-related issues is the effective analysis of ingredients for safety and efficacy.

• Our manufacturer follows cGMP (current Good Manufacturing Practices) modeled after the pharmaceutical industry and well above standards set forth for the Dietary Supplement industry.

• The protocols and standards required for OTC Drug and Pharmaceutical products are used by our manufacturer.

• Our manufacturer’s microbial testing procedures strictly adhere to cGMP protocols and reference the USP (United States Pharmacopoeia, the FDA Bacteriological Analytical Manual, and Official Method of Analysis of AOAC International pharmaceutical standards for consumable products.
• For microbial testing our media preparations are prepared in-house to ensure quality control with complete lot traceability. Our experienced laboratory testing team has worked exclusively in the natural products, pharmaceutical and for government agencies.

• The microbial laboratory is equipped for testing bacterial levels and the presence of pathogens.

In order to ensure that ingredients meet label specifications, our manufacturer is capable of performing the following analytical tests:

• High Performance Liquid Chromatography (HPLC):
  Accurately identifies the existence and concentration of Active and marker compounds.
• Thin Layer Chromatography (TLC):
  Effective and dependable means of positive identification for many of the materials used in dietary supplements.
• UV/VIS Spectrophotometer:
  Performs material identification as well as Active element concentration levels for certain compounds.
• Stability studies:
  to determine shelf-life on materials and finished goods.
• Disintegration:
  to ensure tablet or capsule will properly break down in the body for proper absorbtion.

Our manufacturer’s physical testing laboratory conducts a number of tests on raw materials and finished goods:

• Organoleptic characteristics: appearance, smell, taste
• Density (bulk and tapped)
• Moisture content
• Flowability index
• Particle size determination
• Hardness
• Friability
• At our manufacturer, increased emphasis is placed on scientific verification of product quality and functionality.
• The Total Quality Management (TQM) program at our manufacturer strictly adheres to FDA Drug Standards of current Good Manufacturing Practices (cGMP), and includes:
• Complete Lot/Batch Control and traceability from incoming raw materials to finished goods, laboratory testing of incoming materials and work-in-progress, flow charting for Statistical Process Control (SPC) of key control characteristics, and the final inspections of all finished goods