Quality

AA010180

We adhere to current Good Manufacturing Practices (cGMPs)

  • Complete raw material sampling including identification, analysis and release to predetermined specifications
  • Microbiological analysis to ensure raw materials meet appropriate specifications for levels of harmful salmonella, E. Coli, yeast and molds
  • Inspection of rooms and equipment to be used in blending, milling, drying and coating
  • Sign off procedure prior to start of all processes
  • Double check weighing system of all ingredients to eliminate mixing errors
  • Computer recording of weights eliminated chance of human error
  • Chronological sequence tracking in each step of production to provide a reference record
  • Finished product sample analysis from production line
  • Sample retention from all batches for one year after Best By date
  • Manufacturing spaces are equipped with air-handling systems to prevent airborne cross contamination

Quality Assurance and Control

  • Inspects suites and equipment prior to use to assure their cleanliness, in-process sampling and testing for compliance with weight, hardness, thickness and friability requirements
  • Maintenance of production logs for each piece of equipment and each room used, which facilitates non-conformance investigations
  • Determining in-process and final yields to assure product uniformity
  • Labeling control
  • Regular training sessions with all employees on GMP quality and safety matters

Finished Products Testing

We perform in-process evaluations for every lot during manufacture and verify compliance to release specifications prior to release by Quality Assurance for packaging.  Each product must meet specifications which may include, but are not limited to, the following:

  • Satisfactory assay results
  • Disintegration or dissolution
  • Review of completed documents
  • Batch yield reconciliation
  • Metal detection on packaging lines for tablets and capsules to ensure products do not contain any foreign metal
  • Gluten testing

Analytical Methods 

As an internationally recognized manufacturer of FDA regulated products, we must perform all our operations, including analytical testing, in accordance with strict Federal Regulations (21 CFR , Parts 111, 210 and 211). We are routinely inspected by the agency and all our Quality Assurance, Manufacturing and QC testing capabilities are closely scrutinized for compliance with these regulations. Our Quality Control (QC) laboratory is required to meet the identical quality and operating standards that companies providing contract laboratory services must meet and by law, must function separately from all our other operations, e.g. serve as an independent testing entity.

Our laboratory in Colorado Springs, for example, is equipped with multiple High Performance Liquid Chromatographs (HPLCs) and an Inductively Coupled Plasma with Atomic Emission Spectrometer (ICP-AES) for the analysis of vitamins, minerals, and other active ingredients in raw materials and in-process or finished nutraceutical and pharmaceutical products.

We use analytical methods described by:
  • USP – (United States Pharmacopeia)
  • NF – (National Formulary
  • FCC – (Food Chemicals Codex)
  • AOAC – (American Organization of Analytical Chemists)
 
Our in-house laboratory equipment for testing raw materials and finished goods includes:
  •  IR – (Infrared Spectrophotometry)
  • HPLC – (High Performance Liquid Chromatography)
  • AA – (Atomic Absorption)
  • GC – (Gas Chromatography)
  • UV-vis – (Ultraviolet-visable Spectrophotometry)
  • FTIR – (Fourier Transform Infrared)
  • NIR – (Near-infrared Spectrophotometry)
  • ICP-MS – (Inductively Coupled Plasma-Mass-Spectrophotometry
  • TOC – (Total Carbon Analyzer)
  • CE – (Capillary Electrophoresis)
  • ICP-OES – (inductively coupled plasma optical emission spectrometry)
  • DISSO – (Dissolution of tabets)
  • Auto Titration
  • Microbiology – (Yeasts, Molds, Total Plate Counts, Gram Staining, Speciation)
  • Gluten / Allergen testing – (ELISA – enzyme-linked immunosorbent assay)
  • Cleaning verification via ATP swabs
  • Hardness
  • Friability
  • When required, specific assay methods are developed and validated by our chemists.

VitaCeutical Labs Pesticide Testing Program

Since 2013 we have been implementing a pesticide testing program for raw materials.  This applies to all botanicals and materials certified and marketed as organic.  We test five unique lot numbers from each new manufacturer and then test annually after the vendor is qualified.  We continue to perform analyses daily as we bring in new raw materials.

Pesticides 2016

Double Verified Gluten Free Testing Program

Raw materials are received with a Certificate of Analysis that reports gluten at less than 10 PPM gluten.  The second test is performed in-house on the finished product to confirm all the raw materials combined do not contain more than 10 PPM gluten, using an ELISA procedure (Enzyme-Linked Immunosorbent Assay).  This machine detects the presence of an antigen in a sample to detect the presence of gluten in the product. In 2013 the FDA defined 20 PPM as the standard for gluten free status.  Our standards remain at one-half that, or 10 PPM in the finished product.

All of our stock products are Double Verified Gluten Free.

Allergens

In 2006, the Food Allergen Labeling Consumer Protection Act (FALCPA) went into effect.  The law requires food and dietary supplement manufacturers to clearly list if any of the identified common food allergens-wheat, soy, egg, milk, fish, crustacean shellfish, peanuts and/or tree nuts- are present in the product.  These eight foods account for 90% of the food allergies affecting Americans.  Our “Contains No:….” Statement on our stock products is in accordance with FALCPA in this statement:

“Contains No artificial colors, flavors or preservatives; no wheat, gluten, milk, eggs, peanuts, tree nuts, soy, crustacean shellfish or fish.”

FALCPA does not mandate, regulate or standardize the use of “Advisory Labeling” – the cautionary statements made voluntarily by some manufacturers.

Certifications and Links