This article was sparked from reading Josh Long’s post on Insider Law about inspections of Dietary Supplement firms for compliance with Good Manufacturing Practices (GMPs). These firms had previously failed an inspection and were targeted by the FDA as “high-risk”,…
Master Batch Records, also known as Master Production Records and Master Manufacturing Records, are version-controlled templates for your manufacturing process. Dietary supplement manufacturing facilities are required to create these documents and keep them on file, but what exactly is the…
Let's take a look at the language of the InstantGMP software. You see them on our website, in our training materials and in the software itself - the manufacturing world uses a lot of abbreviations! We've defined a few of…
In cGMP manufacturing, all manufacturers are required to keep Master Batch Records (MBRs) and Batch Production Records (BPRs) in order to comply with FDA regulations. Master Batch Records, also known as Master Manufacturing Formulas, are general manufacturing instructions. Each unique formulation…
The InstantGMP Manufacturing Execution System software solutions were initially developed for in-house use in response to the challenge of significantly improving the way FDA regulated products are developed and manufactured. The proven InstantGMP methodologies are made commercially available as Real-Time…
By now the public--and increasingly the investment and publicity community--is becoming aware of the growing electronic cigarettes/vape phenomenon. The benefit advocates fall into very different camps: some tout a safer smoking experience without ingesting well-known carcinogens; others promote greater flavor…
The vitamin B-complex is a group of water-soluble vitamins that play important roles in cell metabolism. "Vitamin B" was once thought to be a single nutrient that existed in extracts of rice, liver, or yeast. Later research showed that they…
The InstantGMP MES software and SOPs were recently featured in an article by Hank Schulz, a writer for Nutra Ingredients-USA. His article entitled "Integrated data systems help cut cost of GMP compliance," discusses the challenges dietary supplement companies face…
How much should you charge customers for private label and contract manufacturing of dietary supplements and pharmaceutical products? This question could be answered by a variety of methods. A common approach in contract manufacturing organizations is to look back at…
It's hard to find master manufacturing formulas on the internet even though there are as many formulations as there are formulators. We think it's because almost all dietary supplement formulations are kept as trade secrets. We decided to take a…