Thursday, May 19, 2011

Alkemy 101 Newsletter - May 2011

Need FDA Inspection Support?

Alkemists Labs has expanded its consultancy services to rapidly tackle more of the challenges with meeting the cGMP's, such as Quality Systems audits, responding to FDA inspections including warning letters or on-site representation and testing complex dietary supplement finished products.

Some areas of support include the following:

  • cGMP Compliance Audits of your manufacturing operations/parnters
  • General SOP Writing and Guidance
  • Scientific Data Review from internal/external contract labs
  • Response Letters to FDA
  • QC or QA Planning
  • Investigative research including study designs
  • Sampling and In-Process Testing
  • Stability Study Designs & Protocols

Allergen Testing Now Available

Allergen testing for raw material ingredients by PCR Analysis for Allergen botanical ingredients is now available through Alkemists from AuthenTechnologies headed by Danica Reynaud, Ph.D. In an effort to support detection of known allergen contaminants/adulterants botanical raw materials by DNA presence, Alkemists is providing pass-through testing in collaboration with AuthenTechnologies to screen ingredients for customers.

Targeted allergens by PCR analysis from the following:
Almond, Brazil Nut, Hazelnut, Peanut, Pecan, Soy, Walnut and Wheat

Contact Bryan Fine at Alkemists for more information on the types of allergens and testing details.

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