The CDS License will allow us to better serve the container testing needs for those manufacturers of controlled drugs.
CLIFTON, N.J. (PRWEB)
September 13, 2022
CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems, is pleased to announce that it has been granted a Controlled Dangerous Substance license for scheduled drugs under section II through V. The license, granted by the New Jersey Department of Consumer Affairs, in conjunction with the Federal Drug Enforcement Agency, enables CS Analytical to perform testing on controlled and classified drug substances.
“Achievement of a CDS License requires a lengthy and strict adherence to a large number of special requirements and I want to thank the CS Analytical team for their diligence in helping put this program together. The CDS License will allow us to better serve the container testing needs for those manufacturers of controlled drugs,” commented Sandra Cincotta, Director of Quality for CS Analytical.
Controlled drugs utilize a wide variety of container and package configurations that require testing. A number of test protocols require the use of the drug product as part of the test process. For example, dose volume measurements are best performed with actual drug product. The ability to be able to receive, store and perform testing using a controlled drug product allows the CS Analytical Team to meet client and regulatory test requirements in a real-life scenario. CS Analytical has implemented a number of required controls that include the installation of a DEA approved safe, a central station monitored security system and specific and detailed operating procedures around all aspects of handling and using CDS drugs in the testing process.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world’s leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.
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