Standards Driven Processes that excced industry standards
RECEIVING RAW MATERIALS
Standard Operating Procedures (SOPs) are in place and followed to assure that all ingredients used in Rival Labs products are of the highest quality.
These SOPs cover the following areas:
- All incoming shipments of raw materials and labels are inspected for quality and integrity of the materials before being accepted at Rival Labs dock. Product must be undamaged and accurately labeled per cGMP standards.
- Immediately upon receipt at Rival Labs’ dock, incoming material is quarantined in a separate storage area from previously received and approved raw materials. Quality control personnel sample and test as appropriate all incoming raw materials. Upon successful testing, the materials are released from quarantine and are available for use in production.
- Certificates of Analysis (COAs) must be submitted on all ingredients received by Rival Labs. Quality control personnel examine the COAs to assure the materials match what was ordered and are appropriate for use in Rival Labs’ products.
SUPPLIER CERTIFICATION PROGRAM
Raw materials are purchased only from suppliers who have been approved by Quality Control personnel. Suppliers are only approved after submitting documentation that the ingredients they wish to sell to Rival Labs have been manufactured under stringent cGMP standards.
QUALITY CONTROL (QC)
- QC personnel must be qualified by reason of education, training, or experience, or a combination of these factors.
- All Rival Labs products are produced using Standard Operating Procedures rigorously designed to:
- Assure labeled ingredients are present as stated in the Ingredient Legend;
- Assure Supplemental Facts panels are 100% correct as listed;
- Assure batch-to-batch consistency is present in all materials manufactured by Rival Labs.
In-house tests of raw materials and finished goods are accomplished as follows.
- Reference Standards are acquired from trusted vendors to assure analysis results are valid and meaningful.
- The Reference Standard is run on the appropriate instrument, and the instrument response is recorded. Then the raw material of interest or the finished good (the Sample) is run under the identical conditions. A comparison of the Reference Standard and the Sample’s analytical results would yield a reliable answer to the question, “Do I have confidence that my Sample is the same material (or is at a stated concentration) as represented by my Reference Standard?”
- Microbiological testing is done on all ingredients and finished goods. All samples are tested for the presence of Coli, Total Coliforms, Aeronomas, and Salmonella.
- Chemical and instrumental testing is done as appropriate to accomplish qualitative and quantitative identification of raw materials and finished goods.
In-house instrumentation consists of:
- High Performance Liquid Chromatography (HPLC). HPLC testing yields reliable spectral data from which the identity of the item of interest can be determined, as well as quantification of that item.
- Fourier Transform Infrared (FTIR) testing. FTIR yields spectral data useful for identifying raw materials and components of mixtures.
- Ultra-Violet and Visible (UV-Vis)
Spectroscopy. UV-Vis spectroscopy identifies and quantitates raw materials and components of mixtures which possess absorption characteristics in either the visible or ultra violet areas of the spectrum.
- Mass Spectroscopy (MS), both for stand-alone testing and in combination with HPLC (MS-HPLC). These methods are available for chemical identification of compounds or fragments of compounds by mass.
- Analytical Balance is used when required for maximum weighing accuracy. The sensitivity of our instrument is 0.1 mg. which is the industry standard for micro balances.
As well as the analytical instrumentation available as indicated, common laboratory testing (such as moisture determination, titration analysis, etc.) is also available.
The resident chemist at Rival Labs has over 35 years experience in quality control and instrumental chemical analysis. Experience of more than three decades analyzing food and pharmaceutical materials as well as controlled and non-controlled substances at a government laboratory have prepared him to serve the valued customers of Rival Labs.
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