At Pii we are never satisfied with where we are today, but focused on meeting tomorrow’s regulatory expectations

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Quality Assurance

At Pii, quality is at the core of everything we do.

The “c” in GMP is a constant moving target. Because regulatory agencies and industry standards continue to evolve, Pii is focused on exceeding “current” GMP guidelines. At Pii we are never satisfied with where we are today, but focused on meeting tomorrow’s regulatory expectation. We are continuously investing in our understanding of regulatory requirements, adopting best practices and maintaining our credibility with regulatory authorities.

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. But most importantly, our focus on quality is aimed at the end-user who places their trust in the products developed and manufactured at Pii.

Our Quality Approach

Since our founding in 1994, Pii has invested in promoting a culture of exceptional quality. Quality assurance is an overarching theme to every aspect of our operation. 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 team of experienced quality assurance management team includes staff with American Society for Quality (ASQ) certification and a proven track record of successful inspections and regulatory audits to enable product approval.

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 complied, analyzed and reviewed regularly as part of Pii’s Key Performance Indicator (KPI) program. This continuous improvement philosophy ensures that we meet and exceed current GMP requirements.

Our Quality Record

Pii’s facilities are regularly audited by customers and regulatory bodies. On average, Pii completes more than 50 quality audits per year.  Pii views regulatory inspections as an opportunity to learn and continually improve our quality systems. As a result of our strong compliance record, Pii has successfully completed more than 30 pre-approval inspections (PAI) for our client’s products.  Regulatory inspection agencies who have audited Pii’s facilities include:

  • Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • UK Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Korea Food & Drug Administration

We are proud of the success Pii has achieved over the years in maintaining our status as a compliant manufacturer. Yet we remain steadfast in our commitment to quality and continue to work diligently to exceed current expectations.

Our Quality Services

Pii offers full service testing capabilities to support the manufacturing and release of CTM and commercial supplies including:

  • Analytical methods development and validation
  • Release testing of raw materials and finished product
  • Stability storage and testing
  • QP release

Pii’s facilities have been inspected by both the FDA and EMA and are registered with the DEA (Schedules I-V). Our QP release services are offered through our UK division, Pharmaterials. This service allows Pii to offer a seamless product release for materials manufactured in the US for Europe clinical testing or commercial sell. Read More »

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