The importance of extractables and leachables testing in the pharmaceutical and medical device industry has grown significantly in the last few years driven by a substantial growth in global regulatory requirements. A drug product container-closure system should not release chemicals that can accumulate in the drug product in quantities sufficient to present a risk of toxicity, or affect its stability or efficacy. Extractables and leachables testing is also an important component in establishing the biocompatibility of a medical device as required by ISO 10993.
Substances may migrate from different materials and patients may be exposed through different routes of administration. During the drug development process and medical devices study design it is important to evaluate the potential for various chemicals to migrate. Risk assessment of product configuration or manufacturing chain should be performed as well as a proper toxicological evaluation.
Regulatory agencies require extractables and leachables testing to identify any risks of product adulteration. FDA and international regulators are also placing an increasing emphasis on characterizing the chemical components of devices, including colorants and polymers. Failure to demonstrate material safety could result in failure to receive regulatory approval for a product from authorities
such as FDA and EMA. Consequently, extractables and leachables studies are now a crucial component of product release.
This conference will provide a wide and comprehensive overview of critical aspects, technical considerations and strategies for establishing an extractables study design that provides meaningful data, including the advantages and disadvantages of various analytical techniques for the pharmaceutical and medical device industry. The normative approach according to USP, ISO 10993-1 and
ISO/DIS 10993-18) will be discussed in detail.
By attending, participants will gain valuable insight from our first class expert’s comprehensive expertise on how to conduct risk assessment and toxicological evaluation recommending testing options that are up to current industry and regulatory standards and expectations.