InstantGMP™ Release notes for version 3.002.007 and 3.002.008

We’re working on a major update to InstantGMP™, but in the meantime, we’ve added some new functionalities and improvements! InstantGMP™ Release notes for version 3.002.007                      New Functionalities Creation of outgoing WIP/FG materials now allows for the inclusion of strength and suffix which becomes part of the material name which is, in turn, auto assigned a[…]

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[…]

Trump Looking to Trump State Laws?

Previously, White House Press Secretary Sean Spicer commented that the Trump administration plans to crack down on legalized Cannabis. The Justice Department, head by Attorney General Jeff Sessions, reiterated his unfriendly Cannabis stance. Sessions did note that Medical Marijuana would not be targeted by officials but that he would review current policies. It did not[…]

NDI Guidance Would Weaken Supplement Industry According to Jarrow Formulas

The New Dietary Ingredients (NDI) draft guidance will over-regulate and weaken the supplements industry, according to prominent dietary supplements manufacturer, Jarrow Formulas. The Food and Drug Administration (FDA) first issued the NDI guidance in 2011 in an effort to further define the regulations set in the Dietary Supplement Health and Education Act of 1994 (DSHEA)[…]

Louisiana Drug and Supplement Maker Ordered to Stop Production by Courts

Judge Robert G. James of the District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a producer and distributor of several products including drugs and dietary supplements. The owner, Anton S. Botha, was ordered to cease all business operations until he complies with[…]

Cannabidiol/CBD’s State Regulation Conundrum

Unlike the Pacific Northwest and New England, southern states have been slow to pass pro-Cannabis legislation. Several states have voted to approve Cannabidiol (CBD) for very specific conditions and have granted licenses to research organizations, as well as some businesses – but patients face a conundrum. While patients with a qualifying medical condition are allowed[…]

InstantGMP, Inc. and CfPA Present: Electronic Batch Records: Benefits and Implementation Planning Online Training Course

InstantGMP, Inc. and the Center for Professional Advancement (CfPA) have collaborated on a course entitled, “Electronic Batch Records: Benefits and Implementation Planning” InstantGMP, Inc. and CfPA have designed this course with cGMP manufacturing professionals looking to improve or enhance their process, traceability and FDA compliance with electronic batch records in mind. This course invites professionals[…]