Turbulence Ahead for Europe’s Pharma Industry Following Brexit

As the votes were being tallied, the entire world had its eye on the UK. The implications of “Brexit” reverberated around the world as it waited with baited breath. In a 52-48 majority, the UK decided to exit the European Union (EU) after close to 50 years. The actual implementation of Brexit will not be[…]

Dr. Rick Soltero Featured in Vape Mentors Masterclass!

Our very own President, Dr. Rick Soltero, had the opportunity to be part of Vape Mentors masterclass talking about the new regulations coming into effect for manufacturers of e-liquids. Be sure to check it out and check out their other online resources! InstantGMP™ Vape and our Standard Operating Procedures for E-Liquids will help your organization[…]

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[…]

UK Pharmaceutical Sector Bracing for Regulatory Shake-Up Following Brexit Possibility

From Elza Homstedt Pell of EurActiv, pharmaceutical companies are closely watching the “Brexit” referendum for the UK to leave or stay in the European Union (EU) and how it could shake up the pharma regulators. Pell argues that the UK would lose its regulatory influence in pharma over the European Medicines Agency (EMA) if the[…]

Batch Records Defined

All cGMP manufacturers are required to keep Master Batch Records (MBRs) and Batch Production Records (BPRs) in order to comply with FDA regulations. Master Batch Records, also known as Master Manufacturing Formulas, are general manufacturing instructions. Each unique formulation must have its own MBR and should include: Identification of product name. Bill of Materials, detailing[…]

InstantGMP™ MD: Unique Device History Record Solution for Medical Device Production

  Cary, NC – InstantGMP, Inc.’s InstantGMP™ MD electronic Device History Record software seeks to streamline Medical Device manufacturing. InstantGMP™ MD is a viable alternative to available software suites on the market thanks to its unique quality-based workflow that lays the foundation for ISO 13485 compliance. A Unique Software Solution Designed from feedback from medical device[…]

InstantGMP™ PRO: Game-changing Software for Pharmaceutical and Biotech Manufacturing

Cary, NC – InstantGMP, Inc.’s InstantGMP™ PRO electronic batch record software seeks to streamline Pharmaceutical & Biotech manufacturing. With its new sleek design and user friendly interface, version 3.0 of InstantGMP™ PRO aims to change the pharma manufacturing landscape with guided, intuitive modules. Game-changing Software InstantGMP PRO™ v3.0 is the brainchild of Dr. Richard Soltero[…]