Quality Assurance

Providing the highest-quality products and services at every stage is non-negotiable. It’s what earns your trust and respect and we wouldn’t have it any other way.

OUR COMMITMENT TO QUALITY ASSURANCE

Pii quality assurance

Compliance and Collective Success

At Pii, quality is at the core of everything we do. The “c” in GMP is a constantly moving target. Because regulatory agencies and industry standards continue to evolve, we focus on exceeding “current” GMP guidelines. At Pii, we are never satisfied with where we are today but focused on meeting tomorrow’s compliance expectations.

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Delivering Safe and Effective Solutions

Quality is built into everything we do, from our people to our processes, products and services. We believe that investment in quality leads to profitability through competitive pricing, regulatory community trust, an empowered workforce, and improved turnaround time.

Lyophilization
QAS

Our Quality Approach

Since our founding in 1994, Pii has invested in promoting a culture of exceptional quality. Our quality assurance department represents 10% of our workforce, and they offer guidance and oversight at every stage of a product’s development and manufacture.

Our business model and Quality Systems are designed to achieve consistent product quality through thoughtful quality planning, control and measurement. Pii’s Quality Systems consist of four key elements: process performance and product quality monitoring, corrective action and preventive action (CAPA), change management, and internal, customer and regulatory inspections. This data is compiled, analyzed and regularly reviewed as part of Pii’s Key Performance Indicator (KPI) program. This continuous improvement philosophy ensures that we meet and exceed current GMP requirements.

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