Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance
When performing initial qualification audits, it’s important to evaluate all critical systems evenly to ensure compliance. Lack of evaluation of all critical systems can leave Sponsors and their manufactured drug products vulnerable to multiple risks and serious regulatory action.
Learn how ProPharma Group was able to step in and provide a thorough surveillance audit that uncovered 20 observations that were missed during the initial qualification audit.
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The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
Free Webinar: Effective FDA Engagement
FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...