COMAR QUALITY POLICY
Comar is dedicated to satisfying our customers, by continually improving the effectiveness of our Quality Management System. We embrace a proactive approach to quality, based on defect prevention and continuous improvement.
We demand quality from our Management, our Employees and our Suppliers, in order to consistently meet our Quality Objectives for Customer Satisfaction, On-Time Delivery and Operating Efficiency.
We are committed to driving quality throughout the organization and exceeding customer expectations, with focus on CUSTOMERS, PROCESS and PREVENTION.
Quality and Compliance
- FDA medical device registration #2220100
- ISO 9001 and ISO 13485 certifications
- Low particulate manufacturing capabilities
- Statistical process controls
- State-of-the-art vision inspection
- Products listed in Type III drug master files
- Buena, NJ – Dosage delivery systems DMF #16669; Bottles DMF # 7844; Closures DMF # 16762
- Cayey, Puerto Rico – DMF # 6609
- Saddle Brook, NJ – DMF # 4671
- Rancho Cucamonga, CA – DMF # 4671
- Maintain device master files and device history files
- Meet European Union requirements for CE mark certification for specific products
- New molds undergo Installation Qualification, Operational Qualification, and Performance Qualification.
- Work closely with the Centers for Disease Control and Prevention PROTECT Initiative, Consumer Products Safety Commission, and the U.S. Food and Drug Administration to support the development of safer drug delivery methods and enhance overall consumer safety
*Initiatives and certifications listed currently apply to select Comar manufacturing sites
What Is TPI-Three?
TPI-Three is the set of principles guiding how work is accomplished at Comar.
This TPI-Three mindset and set of methods drives our daily thoughts and activities, moving Comar toward the goal of operational excellence across the organization.
“TPI” stands for Total Process Improvement, while “Three” represents three areas of focus and three methodologies for seizing opportunities for improvement. TPI-Three is guided by DMAIC data-driven problem solving tools and quality expectations of Six Sigma, and is practiced every day using Lean Thinking tools.
Areas of Focus
Methodology for Seizing Opportunities for Improvement/Solving Problems
- Systematic approach
- Use and analysis of facts and data
- The right tools for the job
Learn more about TPI-Three