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What was the strategic driver behind your research?
Julie Suman: Several complex challenges are facing injectables component partners, from increased safety and quality requirements to development of sensitive drug formulations, which necessitate the creation of more inert solutions with greater regulatory standards. Drug product manufacturers need flexibility to select components that meet their sterilisation requirements.
What is the regulatory case for extractables and leachables?
Injections and injectable suspensions have the highest degree of concern associated with the various routes of administration, as far back as the guidance document issued by the FDA in May 1999. Current expectations have increased with new methodology defined in the US Pharmacopeia and Product Quality Research Institute (PQRI) parenteral and ophthalmic guidelines. There is also a high likelihood of packaging component/dosage form interaction, hence the intense scrutiny in this area.
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