Signed on December 29, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) has provided the first revision to cosmetic laws since 1938. The new rules will affect all US cosmetic manufacturing, packing, and distribution facilities. These laws are set to take effect by December 2023. The Act defines a cosmetic product as “a preparation of …
After at least eight years in the making, the FDA announced the final rule to improve food traceability for domestic and foreign manufacturers who process, package, or hold foods included on the Food Traceability List (FTL) for U.S. consumption. This rule will require those manufacturers to maintain records containing Key Data Elements (KDE) associated with …
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One of the most recognizable government agencies is the Food and Drug Administration (FDA), which is responsible for protecting public health by monitoring the production and distribution of many product categories, including various foods, drugs, vaccines, medical devices, and cosmetics. Companies who manufacture products in these categories must adhere to strict policies enforced by the …
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Validating an ERP system helps a company ensure that their processes are consistent and operate in accordance with industry standards. The 21 CFR Part 11 validation process establishes documented evidence that, throughout its lifecycle, the ERP system will consistently function in accordance with its pre-determined specifications and quality attributes. For pharmaceutical and medical device companies, …
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…And how to do it in a matter of hours By now, you are probably very familiar with the new design of nutrition fact labels introduced by the FDA. While the goal is to make it easier for consumers to make informed and healthier food choices, many manufacturers are concerned about the challenges they will …
Serialization has been a hot topic in the pharmaceutical industry and will continue to pick up speed as the DSCSA deadlines continue to rollout. Next up: November 2017 when all pharmaceutical manufacturers must serialize down to the unit level. Consider this: A contract manufacturer of aspirin needs to produce one pallet of product for their …
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Just when you thought you were eating healthy foods, the meaning is about to change! Considering the official definition hasn’t been updated in 22 years, we can’t help but wonder: What took so long? Last year, KIND Snacks received a warning letter from the FDA requesting the removal of the term “ healthy ” from …