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[…]

US and EU Sign Agreement to Mutually Recognize Drug Manufacturing Inspections

In 1998, the European Union (EU) and the US signed the Mutual Recognition Agreement (MRA) with provisions specifically about current Good Manufacturing Practices (cGMPs) for drugs but were unable to start implementation. Since 2014, both the US and European Medicines Agency (EMA) revived agreement talks concerning the cGMP provisions. Starting in 2012 with the passage[…]

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[…]

Emerald Cup Cracks Down on Contaminated Cannabis

The Emerald Cup is the oldest and most prominent of the various Cannabis cups, but now is becoming a trendsetter in another regard. Tim Blake, the co-founder of the California-based Emerald Cup realized change was necessary when the cup developed a problem with contaminated Cannabis. The cup’s roots are self-identified as hippie. Growers are supposed[…]

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The New Dietary Ingredients (NDI) draft guidance will over-regulate and weaken the supplements industry, according to prominent dietary supplements manufacturer, Jarrow Formulas.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)[…]