The importance of chemical assessment, including extractables and leachables testing, for the characterization, selection, and qualification of materials, components, and systems used in either pharmaceutical drug product packaging, manufacturing and administration (delivery), or in medical devices, has grown considerably in the last few years, driven by three factors:
- development of new and the revision of existing global regulatory and compendial guidelines,
- increased and more frequent documentation of instances where foreign impurities such as leachables have had an adverse effect on drug product quality and/or profitability, and
- a growing fundamental and practical understanding of the physicochemical processes which contribute to and control material/drug products interactions such as leaching.
Logically and appropriately, then, a rational, comprehensive, and coordinated chemical assessment has become a critical, applicable, and necessary part of a drug product’s or medical device’s marketing authorization dossier/regulatory submission file, with the expectation being that such an assessment be well designed, fully justified, risk based, highly correlated, effectively implemented, properly interpreted, and accurately and unambiguously reported.
Whether the circumstance being investigated involves a packaging system, manufacturing component, administration/delivery system, or medical device, chemical characterization, including extractables and leachables to a necessary and appropriate extent, should be performed. However, each of these circumstances has its own optimal approach, ranging from elementary and straightforward compendial and compliance testing to extractables and/or leachables scouting and profiling which requires an extremely high level of analytical competence, reflected in both expertise and capabilities.
The Nelson Labs Europe team has a vast and successful experience with developing, implementing, interpreting, and reporting chemical assessments in general, and extractables and leachables studies in particular, for a wide variety of situations encountered in the pharmaceutical industry. Rather than offering a cookie cutter, one size fits all approach, we can offer a customized approach, expertly tailored to fit the regulatory requirements specific for your application and based on the type of chemical information you want to obtain when carrying out a specific assessment program.