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 regulatory expectations.
Our Quality Vision
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.
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 consists of four key elements: process performance and product quality monitoring, corrective action and preventive action (CAPA), change management, and internal, customer and regulatory inspections. These data are 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.