Quality Assurance

The strict standards and procedures we have implemented in our quality assurance system guarantees that our requirements for our products and services are adhered to.

 

To support our customers’ expectations for high quality products, we continue to expand and advance our quality control laboratory and processes. With our sophisticated laboratory equipment and experienced Quality Assurance team, Starwest has made a commitment to continued excellence in product quality for over 40 years.

Starwest maintains an in-house laboratory staffed by experienced professionals. We provide complete product analysis, quickly and efficiently, with validated analytical procedures and state of the art equipment. We test every lot that comes in-house, verifying our customers are getting not only a superior quality product, but the right product, and they test safely above or within the required allowable limits. Specification Sheets, Certificates of Analysis, Material Safety Data Sheets, and Product Flow Charts are provided for each of our products.


Our Quality Assurance team includes individuals dedicated to equipment and process validation, document control, product testing, training, and maintenance. We insure that FDA-compliant manufacturing protocols are followed, and our products meet these requirements for identity, strength, quality and purity.


We have designed a full allergen prevention program, and have implemented tight controls in our manufacturing processes to prevent cross-contamination of our products with allergens.

Our validated quality assurance testing includes:

  • Organoleptic testing to ensure proper appearance, color, aroma and flavor.
  • Microscopic and macroscopic inspection for foreign matter.
  • HPTLC for identification, and to verify purity and authenticity.
  • ICP-MS for heavy metal analysis.
  • Microbiology testing for pathogens such as E. coli and salmonella.
  • Chemical analyses for moisture content, volatile oil, ash, and acid insoluble ash.

 

High Performance Thin Layer Chromatography (HPTLC)

In compliance with cGMPs, Starwest currently uses HPTLC testing, which is an essential tool to efficiently and accurately determine product identity and purity. HPTLC is the only single test that allows for 100% botanical ingredient identification, and is the primary chemical test for identification of all pharmacopoeia monographs on botanicals (including USP). By quantifying or comparing the distribution patterns of marker compounds in different solvent systems (unique to each plant and class of actives) against our proprietary Botanical Reference library, our laboratory personnel can confidently and accurately verify product identity and identify known adulterates.

hptlc

 

Inductively Coupled Plasma- Mass Spectrometry (ICP-MS)

Inductively Coupled Plasma- Mass Spectrometry is used to measure trace metals in a variety of solutions. ICP-MS offers a very sensitive, specific and reproducible way to determine heavy metal concentration. It can identify and quantify each metallic impurity with high sensitivity; and, can be used to test for the entire Periodic Table in one analysis. ICP detection limits for most elements are in the part-per-billion (ppb) range.

icpms

 

BRC Certified for Global Standard for Food Safety Initiative (GFSI)

Starwest follows BRC protocol to comply with the Global Standard for Food Safety Initiative (GFSI). BRC is a leading provider of food safety systems and auditor of GFSI standards. The GFSI establishes a worldwide standard for food manufacturers to ensure the highest levels of food safety, quality and accountability. The initiative also directs manufacturers to continuously improve these systems. Starwest first achieved BRC GFSI certification in 2015, and currently holds a AA rating.

We are regularly audited and certified by the American Institute of Baking (AIB), an independent, third party organization, to ensure that we are following BRC protocol and complying with the GFSI. We are committed to the continuous improvement of food safety management systems to ensure confidence in the delivery of safe products to all of our customers worldwide, and we have made the investment necessary to ensure the highest level of safety for all of our products.

cGMP Compliant

Starwest complies with current Good Manufacturing Practices, with protocols firmly in place for documentation, validation, and qualification systems to ensure compliance with the FDA and other regulatory bodies. We thoroughly document every aspect of the procedures and operations involved, including receiving, processing, packaging, and shipping.

We have designed a full allergen prevention program, and have implemented tight controls in our manufacturing processes to prevent cross-contamination of our products with allergens.