Quality of Santegra USA Natural Dietary Supplements
Santegra USA and Garden State Nutritionals have 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 our Quality System, every GSN 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:
Qualiy Assurance - planning, implementation, assessment, and reporting necessary to guarantee that the products we manufacture conform to the requirements and expectations of our clients.
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-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 the our products.
GSN’s ongoing commitment to superior quality is backed up by rigorous analysis of our products in our own in-house testing laboratories.
The Quality Control/Analytical Development Department of GSN 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 testing equipment determines tablet weight, hardness, thickness, and friability, as well as tap density and particle size of powders.
- Our complete Microbiology Lab guarantees that raw materials and finished products comply with strict USP requirements.
- Accelerated shelf-stability testing is performed in a range of humidified and non-humidified chambers.