DDL is pleased to announce it has implemented a GMP compliant quality system at its Irvine, CA laboratory to govern its container closure integrity testing (CCIT) division.
Container closure integrity testing evaluates the effectiveness of a package system’s seal or closure to maintain its sterile barrier over a product’s shelf life. CCI testing is a crucial regulatory requirement in ensuring the quality and safety for pharmaceutical products, as any breach in the package system can compromise the product’s stability and sterility. With the addition of the new quality system, DDL is now able to perform CCI testing on sterile package systems for parenteral drug and biologic products that meet GMP regulatory requirements.
“As the pharmaceutical industry technologies advance, particularly with sterile package systems and novel administration methods, ensuring our quality management system meets or exceeds the industry requirement will provide a higher degree of confidence and reliability for our customer’s regulatory submissions and filings,” said Michael Dominguez, DDL CCIT program manager. “Having a quality system that harmonizes with the multiple regulatory bodies across the globe will help ease the navigation and approach to the regulatory challenges our customers are facing, and ultimately instill a higher value of service for their programs.”
For more information on DDL’s CCIT testing services, or to receive a quote, please contact us or call us at 800-229-4235.