Physical contaminants can be introduced to nutraceutical
products in several ways including raw material from suppliers,
broken or chipped mixing blades, damaged screens and sieves and
from metal on metal tablet and capsule molding processes. Good
Manufacturing Practice (GMP) necessitates having product
inspection safeguards in place at critical control points (CCP‘s) in your process including the mixing/milling room, the tableting room and in final packaging areas.
21 CFR 111.365 states, "You must take all the necessary precautions during the manufacturing of a dietary supplement to prevent contamination of components or dietary supplements. These precautions include: ... (i) Using
effective measures to protect against the inclusion of metal
or any other foreign material in components or dietary
METTLER TOLEDO SAFELINE is the worldwide leader in metal detection and x-ray inspection with both the experience and the product inspection technology to assist you
in developing a HACCP (Hazard Analysis Critical Control Point) Plan to comply with the FDA's new rule.