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In the dietary supplement industry, quality standards vary dramatically from one manufacturer to another. NLI has differentiated itself from others in the health and wellness industry by consistently manufacturing a higher quality product than demanded of the industry. That consistent quality is the result of NLI’s unique quality assurance program: Total Quality Management (TQM). The TQM program meets and exceeds all U.S. Government regulations and strictly adheres to FDA Pharmaceutical Standards of current Good Manufacturing Practices (cGMPs). Based on a Failure Mode and Effect Analysis system, TQM ensures continuous process improvement.
- Review and “approval” of raw material suppliers via a vendor audit process
- Based on material and customer specifications, we independently verify and assay incoming raw materials via in-house or third party laboratory testing
- Ingredient quarantine until laboratory tested to verify identity, physical characteristics, activity and safety
- Complete lot/batch control and traceability from incoming raw materials to finished goods
- Laboratory testing of work-in-progress and finished goods based on specifications
- Floor charting for Statistical Process Control (SPC) of key control characteristics to guarantee consistency throughout the batch
- In-process QC inspection procedures that protect against non-conforming product and ensure consistent product output
- Physical characteristic testing to achieve proper manufacturing standards on every lot produced
- Pre-shipment audits and final inspections of all finished goods
- Finished goods certification process includes raw material test results, finished product Certificate of Analysis, Statistical Process Control (SPC), data results and final product inspection results
- Quality Administration
This area monitors the process control and continuous process improvement function. Included under this function are employee training, internal audits, supplier audits, record retention, cost of quality, and safety.
- Incoming Material Control
This functional area is responsible for conducting 100% inspections on all incoming materials. Under this area, other items are managed, including pre-inspection quarantine, raw material processing and documentation, lot control, supplier requirements, inspection and acceptance plans, statistical analysis and a non-conforming material plan.
- Manufacturing Process Control
This includes monitoring the process and product documentation, non-conforming material management, inspection and control plan, Statistical Process Control (SPC), equipment set-up and usage instructions, and the Standard Operating Procedures (SOP’s).
- Outgoing Product Control
Included under this function are final product inspection, shipping audits, final batch records and statistical analysis results.
- Document Control
As part of an FDA Drug licensed operation, this area is critical. It includes policies, master plans and QA manual, instructions, records, change control, and identification numbering and revisions.
- Gauge Control
This function monitors master gauges for traceability and recertification, gauge capability, calibration procedures and frequency, and preventive maintenance.
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