Our FDA-inspected manufacturing facility operates under strict Good Manufacturing Practices (GMP). We are proud to have earned the coveted NNFA GMP "A" Rating. The kosher-approved facilities have been audited and approved by leading independent bodies as well. From raw material analysis to final product inspection, every production step is carefully monitored and documented, with full accountability and in-process controls. Our Technical Services, Analytical, Quality Control and Quality Assurance groups can offer you a level of scientific support unmatched in the industry.
In addition to our own highly skilled Product Development group, we also maintain a Scientific Advisory Board to help avail our clients of the latest developments and technical innovations. This multidisciplinary team includes leading research scientists, molecular biologists, physicians, pharmacists, clinical nutritionists, herbalists, food technologists, and sports physiologists.
Our experienced Regulatory Affairs group works with our customers and regional health authorities to ensure compliance with the documentation requirements of each country.
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 - GSN 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-conf
The Quality Control/Analytical Development Department consists of a highly trained staff of 15 degreed chemists under the supervision of our resident Ph.D. The department performs testing and inspection pertaining to the approval and release of all incoming raw materials and finished products. We also have the ability to develop and validate 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 tablet weight, hardness, thickness, and friability, as well as tap density and particle size of powders.
Microbiological Analysis (guarantees purity)
- Our complete Microbiology Lab guarantees 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.
Approvals and Certifications
GSN has 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, we undergo frequent GMP audits by our premier clients, who confirm our GMP compliance either with their own teams or by engaging independent auditors.
Our reputation for quality extends around the world to clients in 36 countries. We are one of a select group of manufacturers to have received certification and approval from Australia's Therapeutic Goods Administration (TGA). As dietary supplements for the Australian market must be manufactured to pharmaceutical standards, TGA approval is the ultimate confirmation of superior quality.
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 team can provide valuable assistance to help you to avoid costly errors. We offer the following services, at no extra charge:
- Full label review - ensures accuracy and regulatory compliance
- International registration assistance - we provide and coordinate all required documentation
- Formula modifications - to adapt to the requirements of each country
- Full-time Health Canada consultant - to keep pace with the rapidly changing regulatory environment
- Full service testing, including microbiological and stability studies