InstantGMP™ Release Notes for Version 3.009.001

New Functionalities Like MPRs, BPRs now have a “view only mode” of their Manufacturing Instructions. This “view only mode” appears after the BPR has been Reviewed, Rejected or Added to Inventory. Each Manufacturing Instruction step in a BPR is “locked” whenever the Manufacturing Instruction step requires a signature and it is signed. When the step[…]

InstantGMP™ Release notes for version 3.009.001

New Functionalities Like MPRs, BPRs now have a “view only mode” of their Manufacturing Instructions. This “view only mode” appears after the BPR has been Reviewed, Rejected or Added to Inventory. Each Manufacturing Instruction step in a BPR is “locked” whenever the Manufacturing Instruction step requires a signature and it is signed. When the step[…]

Is Mandatory Dietary Supplement Product Registration Coming?

From Jennifer Grebow of Nutritional Outlook, industry experts believe dietary supplement product registration could be incoming. One attorney that assisted in drafting the Dietary Supplement Health and Education Act of 1994 (DSHEA) noted that the industry is moving towards a mandatory product listing. The registry is needed as a way for the industry to self-regulate[…]

Experts Worried UK’s Pharma Industry Under-prepared for Brexit

The date for the United Kingdom’s exit from the European Union (EU) looms closer and experts are worried that the British pharma industry is woefully under-prepared for the withdrawal. As a member of the EU until March 2019, UK pharma companies comply with the European Medicines Agency (EMA) regulations.  From an article by the European[…]

Important Lessons from the FDA’s Kratom Salmonella Probe

Back in February, many kratom manufacturers recalled products due to Salmonella contamination. The outbreak occurred across 41 states with 199 individuals hospitalized per the Centers for Disease Control (CDC). While the outbreak is on the smaller side, the Food and Drug Administration (FDA) started the probe to better understand why products became contaminated in the[…]

FDA’s Biosimilar Action Plan

In a recent press release, Food and Drug Commissioner Dr. Scott Gottlieb explained the agency’s plan for improving access and competition for biosimilars. Dr. Gottlieb’s emphasis on diversifying biosimilars comes as the FDA continues to strengthen the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). As part of the Patient Protection and Affordable[…]

InstantGMP™ Release Notes for Version 3.007.102 & 3.008.001

InstantGMP™ Release Notes for Version 3.007.102                      Improvements To improve the user experience, we have changed the workflow associated with the “Forgot your password” on the login screen. The email has been moved from the email queue to an immediate delivery mode. InstantGMP™ Release Notes for Version 3.008.001                      New Functionalities Specifications, Requisitions and Inventory can be[…]

InstantGMP™ Release notes for version 3.007.001

New Functionalities New Room Log workflow and data Integrated with Master and Batch Records for easy Room Status access and logs Automatic reminders of weekly and monthly cleaning Integration with Document Manager New overall Room Status Automatic Room Change of status after cleaning is due. Improved overall visual information on Room statuses New “Export to[…]

Make Your Batch Records a Genuine Business Tool

Written by our very own Robert Pochadt –  Those in regulated industries often regard batch records, and their creation, as a sort of necessary evil; those annoying, labor intensive documents mandated by the guidelines that production teams and others love to hate. Making them electronic can alleviate some of the chronic transparency and completeness problems;[…]

InstantGMP, Inc. Introduces Powerful Facility Control Feature with Room Logs Interacting with Production Records

InstantGMP, Inc., the developer behind InstantGMP™ Batch Management software, announces added capabilities to a classic software feature that focuses on achieving complete facility connectivity through integrated room logs. This update provides manufacturers and processors with the ability to achieve interactive control of a facility’s role in production, such as “Clean Rooms” to improve batch quality.[…]