FDA COMPLIANCE

THE NEW REGULATIONS from the FDA for the dietary supplements industry (“Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements”, 21 CFR , Part 111) has brought fundamental changes to the way dietary supplements are manufactured in the USA.

What used to be a food-based production process that focused on hygiene and cleanliness has now been tightly regulated, requiring that the manufacturer ensures the “identity, purity, strength and composition” of the ingredients it uses as well as its finished products.

Nulab has implemented in-process controls to comply with these new rules.



INGREDIENT SCREENING: Nulab screens each dietary ingredient in two steps. First, we validate by analysis its identity and potency. We then make sure that it does not contain contaminants, such as harmful microbes, yeast, mold, heavy metals, pesticides and foreign particles.

IN-PROCESS CONTROLS: Each step of the production process, from the receipt of raw materials to the release of a finished product, has its own precise SOP (Standard Operating Procedure). Following these SOPs ensures that the product is made per its Master Manufacturing Record.



PRODUCT CERTIFICATION: Before we release a product we analyze it to verify its potency and other specifications per its Master Manufacturing Record.