As expected and required for a cGMP, FDA inspected and regulated laboratory, all of the current changes and improvements were documented as part of a formal Management of Change quality process. The overall program was a complete team effort that not only included key CS Analytical Team Members, but also relied on a host of outside vendors to include Public Service Electric & Gas (PSE&G), a commercial electrical contractor and a commercial rigging company that specializes in installation and relocation of laboratory equipment.
About CS Analytical Laboratory
The world’s only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.
Media Contact
Brian Mulhall, CS Analytical, 1-888-571-1207, [email protected], https://csanalytical.com/
SOURCE CS Analytical
