Industry Leader
Genesis PURE is the premier leader in the formulation, manufacturing and marketing of dietary supplements.
Manufacturer
Our manufacturing facilities’ proven ability to combine advanced nutrition science and innovative technologies with proprietary delivery systems and a wide range of packaging options provide our products with unique flair, differentiation, and higher value.
Manufacturing Flexibility
We are proud of our long-standing relationships with many of the industry’s largest, most well-established and highly regarded names. Our manufacturing facilities are designed for high output on process equipment of all scales. This allows the flexibility of meeting the needs of the smallest and largest manufacturing needs.
Product Development
Genesis PURE’s unique position as an industry leader enables us to take advantage of the latest advances and hot concepts in nutrition science. Our experienced and knowledgeable Product Development team chooses from an extremely broad range of ingredients to create many new custom products every year.
The Genesis PURE product development process is a complex process, involving the formation of cross-functional design teams which may include representatives from Marketing, Regulatory Affairs, Research and Development, Quality Assurance, Operations, Graphic Arts, and a handful of specially selected vendors.
A well-designed nutritional formula is just the beginning of a successful dietary supplement product. Equally important is the focus on marketing and the “look” of the product. Our use of cutting edge ingredients and technologies and full marketing support will give Genesis PURE products added value, functionality and market differentiation.
Quality Control
Genesis PURE has implemented a comprehensive Quality System that enables us to achieve our mission of providing a full range of superior dietary supplements to our customers. Under this Quality System, every Genesis PURE employee serves a quality function.
Based on the Federal Current Good Manufacturing Practices (CGMP) for foods, our Quality System is enhanced to incorporate the unique requirements of dietary supplements.
The elements of the system are divided between two domains:
Quality Assurance
Planning, implementation, assessment, and reporting necessary to guarantee that the products conform to our requirements and expectations.
The Quality Assurance Department has broad responsibilities and authority in the following areas:
Quality Improvement — Quality improvement is based on the premise that all work activities can be planned, performed, measured, and improved. QA monitors our progress toward our corporate goal of building a culture in which improvement is continuous and an integral part of the organization.
Personnel GMP Training and Qualification — All employees who come into contact with our products must begin GMP training within the first month of employment. GMP training continues on a regular basis throughout the length of employment. Tests are given to monitor the effectiveness of training.
Internal Audits
QA inspectors monitor all phases of production to assess performance and adherence to GMP and to the SOPs of each department.
External Audits
QA oversees and supervises inspections and audits of our facilities by domestic and international regulatory bodies, as well as by customers and independent auditing firms.
Supplier Qualification
Genesis PURE maintains an audit program to verify our suppliers’ ability to provide consistent products that meet our strict quality requirements.
Document and Record Control
QA is responsible for maintaining all documents, records and Standard Operating Procedures, making sure that they are up to date.
Inspection and Acceptance Testing
QA has the authority to release and reject any component or finished product that does not meet specifications.
Non-Conformances
QA handles the identification, documentation, control, investigation and disposition of all non-conforming materials, components and final products.
Quality Control
Operational techniques and activities that are used to fulfill requirements for quality.
QC activities are used to produce and document the quality of our products.
Genesis PURE’s ongoing commitment to superior quality is backed up by rigorous analysis of our products by qualified testing laboratories.
The department has testing performed and oversees inspections pertaining to the approval and release of all incoming raw materials and finished products. We also have access to the development and validation of new test methods, even for exotic herbal ingredients.
Laboratory equipment and capabilities include:
Chemical Analysis
(guarantees label claims for potency)
Fourier Transform Infrared (FT-IR) and Near Infrared (N-IR) Spectrometers — for positive identification fingerprinting of incoming raw materials.
High Performance Liquid Chromatography (HPLC) — for accurate quantitative analysis of vitamins, amino acids and botanical actives.
Our 7 Waters HPLC Instruments are all interfaced to a Millennium 32 Client/Server System for seamless data integration.
Perkin-Elmer Inductively Coupled Plasma Emission Spectrometer (ICP)— for precise analysis of nutrient minerals and heavy metals.
Beckman UV/Visible Spectrometer— for quantitative analysis by light absorption.
Brinkmann Automatic Titrator — for wet chemical assays.
Tablet Dissolution/Disintegration Equipment — to guarantee conformance with rigid USP specifications.
Physical Analysis
(guarantees consistency and uniformity)
Physical testing equipment determines capsule weight, hardness, thickness, and friability, as well as tap density and particle size of powders.
Microbiological Analysis
(guarantees purity)
Complete Microbiology Labs guarantee that raw materials and finished products comply with strict USP requirements.
Stability Analysis
(guarantees shelf life)
Accelerated shelf-stability testing is performed in a range of humidified and non-humidified chambers.
Regulatory Compliance
Genesis PURE uses only fully compliant GMP manufacturing and packaging facilities, which are duly licensed and are regularly inspected by State and Federal health authorities.
Approvals and Certifications
Genesis PURE’s manufacturing facilities have been audited and quality approved by key industry certifying bodies. These include:
GMP “A Rating” — National Nutritional Foods Association (NNFA)
Kosher Certification (all major authorities)
Additionally, these facilities undergo frequent GMP audits by our premier clients, who confirm our GMP compliance either with their own teams or by engaging independent auditors.
Regulatory Assistance
Since the passage of the Dietary Supplements Health and Education Act in 1994, regulatory compliance has become increasingly complex. Our knowledgeable Regulatory Affairs and Information Services teams provide valuable input to ensure accuracy.