General Chemical Evaluation Analysis

The importance of chemical evaluation, including extractable and leak testing, for the characterization, selection and qualification of materials, components and systems used in pharmaceutical drug product packaging, manufacture and application (delivery) or medical devices has grown significantly, and this is due to the following three factors:

• development of new and revision of existing global regulatory and mandatory directives,
• Increasing and more frequent documentation of situations where foreign impurities such as leaks have a negative impact on drug product quality and / or profitability
• Increased basic and practical understanding of physicochemical processes that contribute to and control material / drug product interactions such as leaching.

In a logical and appropriate manner, a rational, comprehensive and coordinated chemical assessment has become a critical, feasible and necessary part of the marketing authorization file / regulatory submission dossier of a drug product or medical device; designed, fully justified, risk-based, highly correlated, effectively implemented, appropriately interpreted, and reported accurately and precisely.

Whether the investigated condition includes a packaging system, manufacturing component, administration / distribution system, or medical device, chemical characterization, including leaks, should be removed as necessary and appropriate. However, each of these conditions has its own optimal approach from basic and direct compensation and compliance tests, to extractable and / or leaky exploration and profiling, which requires an extremely high analytical capability reflected in both expertise and capabilities.

EUROLAB The team has extensive and successful experience in the development, implementation, interpretation and reporting of chemical assessments in general and extractable and leaky studies in particular, for a wide range of situations encountered in the pharmaceutical industry. Rather than offering a cookie-cutter approach, we can offer an approach that is one-size-fits-all, specifically tailored to suit the regulatory requirements specific to your application, and customized to the type of chemical information you wish to obtain when conducting a particular assessment program.

EUROLAB, with its highly expert team and internationally accredited laboratories, General Chemical Evaluation Analysis It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.