July 6, 2016

Why InstantGMP?

Manufacturers of regulated products are under increased scrutiny by the Food and Drug Administration (FDA) to ensure that their products are of the highest quality and minimize health risks. However, while these manufacturers are concerned with quality. They pay a high price to comply with current Good Manufacturing Practices (cGMPs) and are looking for solutions for compliance that are:

  • Affordable
  • Time and Resource Effective
  • Productivity Enhancing
  • Able to Reduce Risk of Enforcement Actions

FDA Has Taken Enforcement to a New Level

The FDA has unilaterally increased the number of inspections domestically and internationally. The FDA has added a multitude of new auditors, are opening up industry specific agencies, and are stepping up their supply chain/vendor investigations. The FDA has also partnered with numerous other governmental forces in hopes of better protecting consumers from adulterated products.

The FDA has drastically increased the amount of 483 Warning Letters. They are much more detail centered, and scrutinizing every record kept. As industries grow and diversify, the FDA has added in a slew of new experts. These auditors are well-versed in Quality System Inspection.

FDA’s Hot Buttons

With decades of Pharma experience, we understand what the FDA requires for compliance. Companies were mostly cited for failing to comply with cGMPs:

  • Unresolved Deviations
  • Failure to Establish Specifications
  • Failure to Qualify Vendors
  • Produced Adulterated Products
  • Insufficient Documentation
  • Produced Low-Quality Goods

These issues span across industries such as Biotech, Dietary Supplements, Pharmaceuticals, Medical Devices, and now, E-liquids.

Most Cited Issues in 2015 from the FDA

  • No Written Quality Procedures
  • Failure to Establish Specifications
  • Deviations Remain Unresolved
  • Process Controls Are Unavailable
  • Cross-Contamination
  • Inappropriate Tests and Methods
  • No Clean Room
  • Procedures do not Include Scheduled Cleaning and Maintenance for Equipment

Why InstantGMP™?

Our software solutions provide a holistic approach to cGMP manufacturing. It was built by veterans of the Pharmaceutical Industry with decades of Quality and Manufacturing experience. The benefits of using the software align with the business drivers that companies desire:

  • Cost Effective
  • No Additional Need for IT Hardware or IT Personnel
  • Increased Productivity Through Controlled Processes
  • Reduction in Reject Batches, Reworks and Review Times
  • Reduction in Risk of Adulteration, Contaminants, Recalls, and Operator Error
  • Fully Validated, CFR 21 Part 11 and GAMP 5 Compliant

Most of all, our solutions are not just for compliance alone. Many of our clients have purchased our software for purposes such as wanting more control over manufacturing, better understanding their process, and to better manage their inventory. These are only a few examples, be sure to look at our users’ benefits after implementing InstantGMP™.