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Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance

Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance Image

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 was able to step in and provide a thorough surveillance audit that uncovered 20 observations that were missed during the initial qualification audit.

Case Study


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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...

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Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

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Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...