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 met.
Hank recounts the documentation required by FDA Part 111 in order to meet the standards of ensuring identity, purity, strength and composition. This requires standard operation procedures (SOPs), specifications, master manufacturing records, batch records and more. Properly preparing, filling out and arching these documents takes considerable resources at dietary supplement manufacturing companies.
There were three solutions to meeting the GMP challenges identified in Hank’s article: N2N Global offers an enterprise resource planning software for the fresh produce industry. TraceGains is a document management provider for food manufacturers and ingredient processors. InstantGMP™ MES is a manufacturing execution system with electronic batch records that is accompanied by 90 SOPs and Policies that make GMP compliance easy.
According to this article, GMP compliance has been a steep hill to climb for the dietary supplement industry. And the advent of the regulations, which took full force for all sectors of industry in June of 2010, wasn’t good news for the nation’s forests as manufacturers found that achieving full compliance meant generating tens of thousands additional pages of documentation each year.