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Quality Programs
Quality is the backbone of our organization - from every process in place to every product manufactured in our facility. Santa Cruz Nutritionals is committed to ensure products are designed and produced to meet or exceed customer requirements. Our Quality Program meets and exceeds all U.S. Government regulations and strictly adheres to FDA Dietary Supplement Standards of current Good Manufacturing Practices (cGMPs)
Our Quality Program includes six key functions:
- Quality Administration
Experienced QA management team monitors the process control and continuous process improvement functions. Included under this function are employee training, internal audits, supplier quality management, record retention, cost of quality and product safety.
- Incoming Material Control
100% inspections on all incoming materials, including pre-inspection quarantine, lot control and utilization of NIR (Near Infrared) Spectroscopy to insure that each material is unadulterated and meets the identity, purity, strength and composition as defined per the specification.
- Manufacturing Process Control
This includes monitoring the process and product specifications, non-conforming material management, inspection and control plans, equipment set-up and usage instructions, and the Standard Operating Procedures (SOP’s).
- Outgoing Product Control
Included under this function are final product inspection, a positive release program, shipping audits, final batch records and confirmation of in-process control parameters.
- Document Control
This area is critical. It includes policies, master plans and QA manual, instructions, records, change control, and insurance that only the current and correct documentation is utilized.
- Regulatory Compliance
This function insures that appropriate process controls, documentation and QA verifications meet the strict requirements of the cGMP’s for Nutraceutical Supplement manufacturing, in addition to Cook & Thurber’s Food Safety and Quality Audits.
Our Credentials and Certifications
- FDA-registered facility.
- NSF certified for current Good Manufacturing Processes (cGMPs) for dietary supplements.
- NSF Cook & Thurber approved.
- Approved by Quality Assurance International (QAI) to manufacture organic products in compliance with the USDA’s National Organic Program standards.
- Regularly inspected by state and federal health authorities
- The approval of many of the top worldwide dietary supplement companies.
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