Marian Boardley is an independent consultant assisting clients to comply with 21 CFR 111, the cGMPs for Dietary Supplements and other applicable regulations.
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 also assess internal and contract laboratories for compliance with GMPs and FDA guidance for laboratory testing.
- Dietary Supplement cGMP Compliance and Audits
- Testing Strategies for Botanical Ingredients
- Supplier Qualification and Audits
- SOPs and Work Instructions
- Technical and Laboratory Documentation
- Quality Assurance Project Management