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[…]

InstantGMP MES v2.051 Update Adds Barcode Scanning and More Features

Cary, NC – InstantGMP, Inc. announces their latest features and improvement to its Manufacturing Execution System. In the latest version, InstantGMP MES v2.051 customers will find a new barcode scanning solution that makes material handling easier. Users can also use the barcode scanning capabilities to scan a badge to sign off on materials, master production[…]

InstantGMP MES update includes New Features & Other Improvements

The latest version of InstantGMP MES will be available Thursday, July 9th and will include the following features and improvements: Barcode Scanning Users will now have the ability to scan barcodes into the InstantGMP system, which will save time on material handling. The barcode scanning capabilities also come into play with the new e-signature scheme,[…]

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[…]

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[…]

Prioritize GMP Compliance When Choosing Software

This post was written by Robert Pochadt, InstantGMP Sales Director. It is imperative that when considering material management and manufacturing automation software that one evaluates the quality of the regulation checks and balances integral to the system and aims to prioritize GMP compliance. One of the “10 things that ERP and manufacturing systems vendors won’t[…]

Commit to Paperless Manufacturing on Earth Day

Celebrate Earth Day 2015 by committing to switch to paperless manufacturing! In addition to saving trees, paperless manufacturing saves your supplement manufacturing facility time and money. How InstantGMP Helps InstantGMP’s manufacturing software is cloud-based, which means it’s not installed on your computer. it is accessed via the web from a secure link. This means it[…]

Webinar: Tips for GMP Compliant Master Batch Records

  InstantGMP and Marian Boardley are joining forces to present Tips for GMP Compliant Master Batch Records. The webinar will take place on April 21, 2015 at 1:00 PM. The cost to attend is $25. In 2014, nearly 10% of 483 observations by the FDA stemmed from issues with Master Batch Records. Improving Master Batch[…]

Material Specifications required in Master Manufacturing Records

Recently, a question was posed in a LinkedIn group regarding revising Master Manufacturing Records and whether specifications need to be included in the record. When revising MMRs or MPRs, you should first consult your SOPs for document control, MMRs and specifications. Specifications should be separate documents including the tests, methods, limits and frequency of testing[…]

InstantGMP MES 2.046.002- Quickbooks integration

Release Notes for InstantGMP MES: QuickBooks integration New Functionality Data transfer to Quickbooks – Requisitions and Current Inventory. Added Average Cost/Unity field and Account for Materials – Quickbooks. Added Costing Functionality to BOM Calendar. Material Types are pre-populated and chosen from a drop-down box. Improvements Vendor name included on additional screens for easier traceability. Prevents[…]