GMP Certification: How to Prepare to be Certified

GMP Certification means that a manufacturing facility, its policies and SOPs have been evaluated by a 3rd party organization. It’s important to know that the FDA itself does not certify nor does it recognize certifications. However, there are other benefits to certification including marketing, company reputation, consumer requirements or simply to take an extra step[…]

Success Story: Haus Bioceuticals Creates Quality Products with InstantGMP

We love a good customer success story and are thrilled that InstantGMP software helped Haus Bioceuticals navigate the sometimes rough waters of GMP compliance. Want to share your story? Contact Amy Howard. Haus Bioceuticals, a pioneer in natural medicine development, began using InstantGMP MES in concert with its full set of Standard Operating Procedures (SOPs)[…]

Haus Bioceuticals Creates Quality Products with InstantGMP

Cary, NC – Haus Bioceuticals, a pioneer in natural medicine development, began using InstantGMP MES in concert with its full set of Standard Operating Procedures (SOPs) in April, 2013. “We had a brand new facility and used InstantGMP as a pillar”, says Adam Payne, COO of Haus Bioceuticals. “We wouldn’t have been able to start[…]

DSHEA/ 21 CFR Part 111 Define the Term “Dietary Supplement”

The definition of the Term “Dietary Supplement” as set by DSHEA and 21CFR Part 11 is important to adhere to in manufacturing and advertising. Recently the FDA came down hard on a company selling enhanced spring water. The FDA took issue with the company representing their water products as conventional foods. The problem the FDA[…]

Change Control and Reviewing of SOPs

Change Control is an integral part of any Quality system of an FDA regulated product. This includes protocols, master records and every SOP in the plant. As a general rule, Standard Operating Procedures (SOPs) should be reviewed and revised every two years. However, realities of ever-changing workplaces and the convenience of paperless systems means that[…]

GMP Certification Webinar Preview: Finding a Reputable 3rd Party Certification Organization

Finding a Reputable 3rd Party Certification Organization InstantGMP’s Prepare for GMP Certification webinar is just days away! Gretchen Rizor, our Support Specialist and Quality expert,  will share helpful information on the process for GMP certification and how to prepare your supplement manufacturing facility for a GMP audit. The webinar will take place on Tuesday, January[…]

Barcodes, BIN Location and Improved Specifications, Oh My! – Coming in 2015 –

Happy New Year! We hope you are as excited about 2015 as we are. Barcodes, Bin Location and Specs, oh my! As always, we are listening to our customers and continually adding features to InstantGMP MES. Here’s a peek at what’s on tap for 2015: Barcodes – Soon, you’ll be able to generate barcodes and[…]