Most Common GMP Citation for Supplement Producers: Not Establishing Specs

A few weeks ago, the Rocky Mountain Dietary Supplement Forum saw who’s who of the dietary supplement industry converge in Boulder, Colorado. According to this article by Josh Long of Natural Products Insider, numerous FDA officials gave presentations regarding their experiences and noted that failing to establish specs is the most common GMP citation in[…]

InstantGMP MES v2.051

Let’s take a look at all the new features, improvements, and fixes in InstantGMP MES v2.051: New Functionalities New barcode scanning solution that enhances material handling. Ability to permanently “hide” and filter Master Records. New system-wide digital signature scheme implementation through barcode scanning of validated user badges. Implementation of Company Logo on login screen along[…]

Quality may not be free, but it is certainly worth the investment

Quality is not free. It implies that research went into the design of a product. Take, for example, sewing. When a professional takes on the task of sewing a custom outfit by hand, he or she needs to take into consideration: Design ideas. Color combinations. The pattern based on function, comfort and customer requests. Time researching[…]

Quality Systems and SOPs for Manufacturing GMP Products

Quality Systems are made up of Standard Operating Procedures (SOPs) and policies, but there is more to the picture than just the individual documents. A well-organized quality system also defines the relationships between procedures. In any organization, almost every process is dependent or has an impact on another.  While each SOP may define a select[…]

Voices on Quality: Striving for Perfection: Ode to Quality Managers

Voices on Quality: Ode to Quality Managers. In celebration of World Quality Month, members of the InstantGMP team each wrote pieces on what quality means to them. This post was written by our Sales Director, Robert Pochadt. We live in an imperfect world. It’s just that way. Most end manufactured or designed products have no[…]

Voices on Quality: Essential Steps for Implementing a Quality System

Our celebration of World Quality Month continues with a guest white paper, Essential Steps for Implementing a Quality System by Richard Youngstrom. Richard has over 35 years of experience in the pharmaceutical industry and has worked with Schering Corporation, Teva Pharmaceuticals, and Anrx among others. His career started with bench work on drug discovery and[…]

Voices on Quality: Quality Means Meeting Expectations

In celebration of World Quality Month, members of the InstantGMP team wrote pieces on what quality means to them. This post was written by our Marketing Manager, Amy Howard. Imagine you are in a restaurant. You order shrimp scampi and it is just amazing. The shrimp is fresh and the chef uses just the right[…]

FAQ Friday: Quality Attributes of InstantGMP Manufacturing Execution System

Today’s FAQ Friday is dedicated to World Quality Month! What are the Quality Attributes of InstantGMP Manufacturing Execution System? Quality is “built in” to all aspects of the InstantGMP™ manufacturing execution system. Starting with a “Quality by Design” approach, this electronic batch record system and the SOPs were developed at the same time by a[…]

Voices on Quality: SOPs are the Foundation of a Quality System

In celebration of World Quality Month, members of the InstantGMP team wrote short pieces on what quality means to them. This first post was written by our President, Dr. Rick Soltero. Quality has a simple definition: Meeting Specifications.  Setting and meeting specifications is a little more involved.  In order for your products to meet specifications[…]

Supply Side West: Industry Insights, Quality and GMP

Our Supply Side West experience began with unique insights about the natural products industry. Trending topics at the United Natural Products Alliance and Dan Fabricant’s Keynote session included regulatory issues, contaminants, increased focus on claims and defining he word “natural”. Fabricant pointed out that whether you like it or not, the U.S. government plays a[…]