Quality Assurance



Tri Pac provides full-service quality control capabilities. We can incorporate

customer quality systems into our operations.

​

Our Quality Assurance systems include:



• Compliance/ Certification to FDA 21CFR 210/ 211/ 820, cGMP, ISO 9001: 2015, ISO 13485:2016, UL GMP, Canada FDR, ISO 22716 & ANSI Z1.4

• Incoming, in-process and final product release protocols

• Validated production and laboratory systems

• Validated and Verified methods and technology transfers

• ​Specification and documentation control and lot traceability record management

• Core Tools - LIMS, QM Suite, PFMEA, SPC, Vision Systems

• Ongoing audits and closed-loop corrective action system

• Onsite wet chemistry laboratory facilities scaled to fully integrate with your testing requirements

• Onsite Microbial Analysis for yeast, mold and bacteria testing

Tri Pac provides efficient service, giving you the most value for your packaging investment. Every product has its specifications listed in our Total Service Manual. The Total Service Manual guides your products from incoming quality inspection, formulation and all the way through manufacturing.



Our inspection process meets rigorous industry standards. We ensure precision throughout all stages of your product's development. Our plant operates under current Good Manufacturing Practices (cGMP) procedures and conforms to both local and international regulatory authorities and national compliance agencies.

Highlights

 

 Testing System​s

Calibrated & Qualfiied equipment

In-line Vision Systems & SPC

Wet Chemistry​ & Microbial Analysis

Part 11 Compliant LIMS

Process Checks​

Process & Packaging Validation​

Cleaning Validation

Product Analysis

Master Batch Records

Part 11 Compliant QMS

Compliance Controls​​

Quality Management System

Lab Information Management System

Environmental Management Systems

Regulatory & Legal

Analytical & R&D Labs

Calibrated & validated equipment​

Qualified analysts-supervisor team