Source: https://www.instantgmp.com/tag/21-cfr-part-111
Timestamp: 2018-12-16 10:58:07
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Matched Legal Cases: ['art 111', 'art 111', 'art 111', 'art 111', 'art 11', 'art 111', 'art 211', 'art 11', 'art 111', 'art 211', 'art 111', 'art 211', 'art 111']

21 CFR Part 111 Archives - InstantGMP, Inc. Your SEO optimized title
Tag: 21 CFR Part 111
Supplement Maker Warned by FDA for Misbranding and Procedural Violations
Per FDA News, Sanapac, a dietary supplement manufacturer, was notified by the Food and Drug Administration for GMP violations, adulterated products, and misbranding products after an inspection in 2016. After an inspection in November, FDA inspectors returned the following month and found numerous issues in regards to the lack of written Standard Operating Procedures for[…]
Posted in Blog, InstantGMP MES, Posts Tagged 21 CFR Part 111, and Cosmetic Act, Batch Records, cGMP, Drug, FD&C, FDA, Federal Food, Master Records, Part 111, Sanapac, Specifications, Warning Letter
Posted in Blog, InstantGMP Vape, Posts, Vape Legislation Tagged 21 CFR Part 11, 21 CFR Part 111, 21 CFR Part 211, E-Liquids, Electronic Cigarettes, FDA, GMP Compliance, GMP for Dietary Supplements, GMP Manufacturing Software, InstantGMP Vape Leave a comment
Booming Natural Supplements Business in China
From Natural Products Insider, health food sales in China are estimated to reach RMB300 billion ($47.5 billion USD) by 2019. More and more Chinese consumers are looking to natural supplements as rates for certain illnesses such as lung cancer and breast cancer are on the rise, and they are looking to purchase foreign health products. It[…]
Posted in Blog, InstantGMP MES, Posts Tagged 21 CFR Part 11, 21 CFR Part 111, 21 CFR Part 211, Batch Production Records, cGMP Dietary Supplements, Dietary Supplements, Electronic Batch Record, Electronic Batch Records, FDA, GMP, GMP Compliance, GMP for Dietary Supplements, GMP Manufacturing Software, InstantGMP MES, Manufacturing Execution System, Manufacturing Software, Validation Leave a comment
In February of this year, the New York State Attorney General’s Office investigated major retailers for selling dubious and potentially dangerous herbal supplements according to the New York Times. They targeted Walgreens, Target, Walmart, and GNC, all well-known big box retailers that generally sell safe products. The authorities said that they had tested the herbal[…]
Posted in Blog, InstantGMP MES, InstantGMP Vape, Posts Tagged 21 CFR Part 111, 21 CFR Part 211, barcode, Dietary Supplements, Electronic Batch Record, Electronic Batch Records, FDA, GMP, GMP Compliance, GMP for Dietary Supplements, GMP Manufacturing Software, InstantGMP MES, New York Leave a comment
Material Specifications required in Master Manufacturing Records
Recently, a question was posed in a LinkedIn group regarding revising Master Manufacturing Records and whether specifications need to be included in the record. When revising MMRs or MPRs, you should first consult your SOPs for document control, MMRs and specifications. Specifications should be separate documents including the tests, methods, limits and frequency of testing[…]
Posted in Blog, InstantGMP MD, InstantGMP MES, InstantGMP Vape, Posts Tagged 21 CFR Part 111, Dietary Supplements, FDA, GMP, GMP Compliance, GMP for Dietary Supplements, Manufacturing, Master Batch Record, Master Records Leave a comment