FDA Prioritizing GMP Re-Inspections for High-Risk Dietary Supplement Firms

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”, thus precipitating the need for re-inspection. Josh reports that half of the dietary supplement companies[…]

Master Your Master Batch Records

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 FDA looking for in a Master Batch Record? In addition to a list of instructions[…]

Language of InstantGMP Software

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 them for you here:   21 CFR Part 11 FDA regulations covering security electronic signatures[…]

cGMP Manufacturing: MBR and BPR Defined

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 must have its own MBR and should include: Identification of product name. Bill of Materials,[…]

InstantGMP and GAMP 5 Validation Standards: Improving FDA regulated products

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 web based ‘Cloud’ applications that provide immediate ‘Fast Track’ solutions for initiating and maintaining compliance[…]

A Manifesto for the Emerging Electronic Cigarettes and Vape Industry

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 and nicotine dose variety than just “burning one”; then there are the cool riders on[…]

Master Manufacturing Formula for Vitamin B Complex with Vitamin C Tablets

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 are chemically distinct vitamins that often coexist in the same foods. A Vitamin B complex[…]

InstantGMP MES Featured in Nutra Ingredients Article

  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 in complying with Good Manufacturing Practices (GMP) and the new ways these challenges can be[…]

Cost and Pricing Model for Private Label and Contract Manufacturing

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 what was charged for similar products in the company’s history and just make a guess[…]

New Resouce for Master Manufacturing Formulas

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 new, open approach to master manufacturing formulas and to provide some examples of master batch[…]