Overview

Tenco has been committed to quality since day one of our operation. Our Quality System is a formalization of our consistent effort to ensure that all product that leaves our facility meets or exceeds or customer's expectations.

Registrations

Our quality system is based on FDA GMPs, 21 CFR Parts 210 and 211, and we are in the process of expanding our quality system to conform to Part 820 requirements as well. We are registered with FDA as Drug Repackager/Relabeler, and we are also registered with the PA State Department of Health. We also have a registration pending with the US Drug Enforcement Agency.

Quality System Highlights

Some of the key highlights of our quality system are:

• Standard Operating Procedures Manual
• Comprehensive Training Program
• Equipment Validation
• Equipment Maintenance Program
• Packaging Line Validation
• Incoming Material Inspection
• ANSI-Based In-Process Sampling
• Product Reconciliation
• Printed Materials Reconciliation
• Final Review and Release