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Unwavering Commitment to Quality and Regulatory Standards

At Praxis Packaging, quality is more than a part of our process — it’s the basis of our culture. With over 30 years of experience in pharmaceutical and consumer product packaging, we recognize the critical importance of adhering to stringent regulations and requirements.

Our approach to quality and regulatory compliance is comprehensive, ensuring that every aspect of our operation meets the highest standards. We provide ongoing training, meticulously document our staff’s qualifications, and continually monitor and review each team member for effectiveness.

Accuracy & Quality Assurance Packaging

We provide 100% assurance that all customer specifications are met through our comprehensive quality control measures, which include:

  • Documented equipment qualifications
  • Packaging validations
  • Supplier quality management program/vendor qualifications
  • Performance checks
  • Cleaning validations

Our world-class quality control solutions encompass automated and manual in-process checks, ensuring cGMP-compliant accountability and control. We also utilize Single-Use Loggers to precisely monitor temperature controls, humidity, and air quality, ensuring total particulate and micro counts are within safe limits.

Meeting All Regulatory Standards for Quality and Safety

We relentlessly pursue quality with a rigorous, ongoing process for governmental and regulatory compliance, routinely meeting or exceeding customer expectations. Praxis understands, manages, and implements an evolving various supply chain, regulatory, environmental, and quality standards. We are registered and compliant with many agencies, including:

  • FDA Compliant
  • US DEA Compliant
  • EPA Compliant
  • Michigan Department of Agriculture Compliant
  • GDFUA (Generic Drug User Fee Act) Compliant
  • Kosher and Organic Certified

Why Choose Praxis for Quality and Regulatory-Compliant Packaging?

✓Expertise and Experience

With over 30 years in the industry, we understand the nuances of pharmaceutical and consumer product packaging.

✓Comprehensive Quality Assurance

From equipment qualifications to packaging validations, we ensure that every aspect of our process meets the highest standards, including but not limited to regulatory, environmental, and quality.

✓Adherence to Regulatory Standards

At Praxis, we know that the pharmaceutical industry is always evolving. That’s why we stay ahead of of evolving regulations and maintaining compliance.

✓Customer-Centric Approach

We don’t take a one-size-fits-all approach to packaging. We tailor our solutions to meet and exceed customer expectations in quality and safety, no matter their product or market.

Additional services

> Expert consulting

> Package design & development

> Inspection & rework solutions

> Primary Packaging

> Secondary Packaging

Connect with Our Quality and Regulatory Experts

At Praxis Packaging, we are dedicated to upholding the highest quality and regulatory compliance standards. Our team is ready to assist you in ensuring your products are packaged with precision and care, meeting all necessary regulations and standards.

Interested in partnering with a leader in quality and regulatory-compliant packaging? Contact Praxis Packaging today.

 

 

 

Speak with our team about Quality & Regulatory

Carolyn Wright, DRSc

Praxis Packaging Solutions

Sr. Director of Quality

Carolyn oversees quality assurance, regulatory compliance, and process improvement initiatives for Praxis Packaging and Unette Corporation.

With over 30 years of experience in the pharmaceutical and consumer goods industries, Carolyn has held leadership roles in process development, manufacturing, validation, and quality engineering. Her expertise spans OTC, medical devices, nutritional, and cosmetic products.

Carolyn holds a BS in Material Science and Engineering from Michigan State University, an MS in Regulatory Affairs from Northeastern University, and a Doctorate in Regulatory Science from the University of Southern California. She is also a certified Six Sigma Black Belt.

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