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Quality Investigations

Quality Investigation and Corrective and Preventative Action (CAPA) Support

A key component of any modern quality system in the pharmaceutical, biologic, and medical device industries is the risk-based response to observed manufacturing, testing, and distribution discrepancies, or as the result of product complaints. Good Manufacturing Practice (GMP) regulations and industry guidance all describe the criticality of implementing a structured approach to performing investigations with the intent of determining root cause of the discrepant issue. Determining the root cause is necessary to implement specific and effective corrective and preventative action (CAPA) to remediate and prevent reoccurrence of the issue, and consequently facilitate continuous improvement.

ProPharma Group: THE Leading Investigation and CAPA Experts

For over 20 years, ProPharma Group has been providing quality investigation and CAPA support to clients around the world. Over the years, our experts have delivered more than 20,000 investigation reports. Our support has ranged from a single investigator up to teams of 45. Our experts have proficiency in all aspects of the pharmaceutical and biotech industry, including but not limited to active pharmaceutical ingredients (API)/drug substance, drug product, and medical devices.

What differentiates ProPharma Group from other service providers? Process + People

Our project success follows a thorough project initiation procedure that dictates everything from onboarding to resource loading through execution of deliverables and metrics reporting. Based on experience and industry knowledge, we have refined our project delivery to have the greatest impact on our sponsor’s program. We know that staffing a project without a plan is not an efficient execution model and does not deliver the maximum value to a client.

Our diverse and experienced subject matter experts are another key to our success. The lifecycle of discrepancy and complaint management can be quite complex and often requires input from multiple subject experts. ProPharma Group has all the experts needed to support your program. Our team will integrate with yours and provide investigation and CAPA support within your quality system, or we will help to develop and optimize your program. We have over 1,300 colleagues, providing diverse and extensive experience in numerous product types and dosage forms. Our team has a wealth of knowledge accumulated through many years of industry support in consulting roles as well as operating company management defending investigation and CAPA systems to regulatory bodies.

When you partner with ProPharma Group, you gain the experience of the entire company—not just the team assigned to your project. This breadth and depth of knowledge enables ProPharma Group to provide you with the support and guidance you need when you need it.

Our best-in-class Quality Investigation and CAPA support services include:

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Looking to Maintain Quality and Compliance for Your Product?

Contact us to learn how our team of specialists can ensure quality and regulatory requirements are met throughout your product’s lifecycle to successfully bring your product to market.

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