Category Archives: Quality

18Jul/16
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Next Steps in FDA’s Global Transformation

By: Ellyn McMullin, Research Associate

The Agency Continues to Take Measures to Ensure the Safety and Quality of Imported Medical Devices

Five years ago FDA unveiled its new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain. According to the agency, in 2011 half of all medical devices used in the United States were imported, while 80% of the active pharmaceutical ingredients in medications sold here were manufactured elsewhere. It was optimistically estimated that imports of FDA-regulated products would triple between 2007 and 2015; of course, with the severe recession, the results did not quite reach that projection. However, the increase in imports was still significant.

A key component of the FDA’s new approach (as detailed in a special report “Pathway to Global Product Safety and Quality”) was to partner with its counterparts worldwide to insure and improve global product safety and quality. As reported in 2014, the FDA had at that time more than 60 agreements with their counterparts to share some information in inspection reports.

Continue reading this article in MedTech Intelligence.

29Jun/16
quality

FDA and Quality Metrics in Biopharma

By: David R. Somers, Senior Industry Analyst

Moving Right Along 

The continuing efforts by biologic and pharmaceutical manufacturers to join the FDA in improving product quality, reducing inspection costs, increasing the effectiveness of product monitoring, and streamlining reporting requirements have crossed the Rubicon of mere theorizing, discussion, and contemplation into firm and proactive steps. Those efforts have been aimed at the establishment of acceptable and realistic standards of measurement for product development, testing, implementation, distribution, and monitoring. These activities are in concert with the broader effort by FDA to promote innovation, increase stakeholder involvement in quality, and enhance the safety of the supply chain.

To support this initiative, the International Society for Pharmaceutical Engineering (ISPE) created a cohesive, comprehensive series of criteria for the measurement of critical parameters needed to define and control quality in biologic and pharmaceutical manufacturing.  Subsequently, using many of the metrics developed by the ISPE, the FDA submitted a draft guidance document called Request for Quality Metrics.

Continue reading the full article in Outsourced Pharma.

26May/16
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QMS comes from the Cloud

Veeva Expands Native Cloud Offering for Quality Management with Vault QMS

Life Science companies are increasingly operating within global and outsourced models.  While the operational paradigm has changed, quality systems and technology infrastructures have not kept pace.  As a result, managing quality and compliance activities in an increasingly fragmented ecosystem is a difficult and labor intensive process.Too-Much-Tech

This is not for a lack of technology. Axendia’s research consistently shows that most companies use a multitude of stand-alone systems. These were generally implemented by functional areas and sites to address specific regulatory compliance needs. Consequently, most companies have redundant systems that are generally accessible by a limited number of people and only within a company’s four walls.This approach is very inefficient and makes reporting a single version of the truth across the global and outsourced ecosystem difficult if not impossible since it:

  • Creates data islands that hinder visibility across a global organization
  • Makes solving companywide problems across data islands extremely difficult
  • Is tedious and costly to coalesce data into meaningful information

As a result, it is difficult to connect the dots to make “intelligent “decisions.

A Solution from the Cloud? Continue reading