Health

DDL Implements a GMP compliant quality system at its CA Lab for its CCIT division

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DDL is now able to perform CCI testing on sterile package systems for parenteral drug and biologic products that meet GMP regulatory requirements.


IRVINE, Calif. (PRWEB)

DDL, Inc. announced today that 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.”

DDL will showcase its CCI testing, as well as its package, medical device and material testing service offerings in Booth #1253 at the INTERPHEX conference being held April 25-27 at the Javits Center in New York, NY. For more information on DDL’s testing services, or to receive a quote, please contact DDL at DDLinfo@ddltesting.com or call us at 800-229-4235.

About DDL

DDL is a third party independent testing facility that offers expertise in medical device, materials and package testing primarily serving the life sciences industry. DDL’s testing laboratories are located in Eden Prairie, MN, Irvine, CA and Edison, NJ. Visit https://www.DDLTesting.com for more information about the testing services offered by DDL.

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