Since 2008, Marian Boardley has been an independent consultant assisting over 60 clients to comply with 21 CFR Part 111, the cGMPs for Dietary Supplements and other applicable regulations. Services include:

  • Dietary Supplement cGMP Compliance and Audits
  • Label Reviews and Supplement Facts Mockups
  • FDA 483 and Warning Letter Responses
  • Testing Strategies for Dietary Supplements and Dietary Ingredients
  • Supplier Qualification and Audits
  • SOPs, Master Manufacturing and Batch Records, Specifications
  • Technical and Laboratory Documentation
  • Quality Assurance Project Management
  • Food Safety Plans and FSMA Compliance (PCQI)

The challenges for manufacturers and distributors in meeting current FDA requirements for good manufacturing practices can be a significant effort for any company, large or small. I advise clients in the food, drug, and dietary supplement industries in current GMPs, conduct audits for compliance with applicable regulatory requirements for manufacturing, labeling etc. and help establish appropriate procedures and policies for all aspects of quality assurance and manufacturing operations. I provide expertise on identity testing for dietary ingredients, raw materials, and selection of lab instrumentation. I can help write specifications, manufacturing records, SOPs, technical, laboratory, and process documentation, I assess internal and contract laboratories for compliance with GMPs and FDA guidance for laboratory testing. I have worked with a number of homeopathic OTC manufacturers and distributers. I recently became a Preventive Controls Qualified Individual as required by the Food Safety Modernization Act.