Indiana Looking to “Shake Up” the E-Liquid Industry with Regulations

House Bill 1432 authored by an Indiana Representative Kevin Mahan is turning heads. The Bill is looking to set a legal definition of an e-liquid, and require manufacturers of e-liquids to undergo rigorous standardization lest incurring civil or criminal penalties. Portions of the bill have passed and are slated to go into effect in July[…]

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[…]

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[…]

Manufacturing Software Validation – Security Scheme

In manufacturing software validation, a security scheme is used to establish a permission set for each user role. This prevents users from accessing screens or functions that are outside their responsibility or authority. Security is managed through roles, objects, actions and access. Roles are permission sets granted to users. Roles restrict the user’s access to[…]