General Evaluations

The importance of chemical assessment, including extractable and leak testing, has greatly increased for the characterization, selection and quality of materials, components and systems used in pharmaceutical drug packaging, manufacturing and application (delivery) or medical devices. It is due to three factors:

• developing the new one and reviewing the current global regulatory and mandatory guidelines,
• 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 presentation file of a drug product or medical device; designed, fully justified, risk-based, highly correlated, effectively implemented, properly interpreted and accurately and clearly reported.

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. We can offer an approach that is specifically tailored to suit the regulatory requirements specific to your application and tailored to the type of chemical information you wish to obtain when carrying out a particular assessment programme.

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