Kishore Kumar Hotha

Regulatory requirements for extractables and leachables are utmost important step in submission of the products to the regulatory agencies in the category of opthamalics and orally inhaled nasal drug products. There were several criticalities associated in the container closure system assessment in identifying the probable leachables that could impact the quality of the product. Control extractions studies provide an insight based on the technical characteristics and logical conclusions made. PQRI guidance document provided major insights in understanding the analytical evaluation limits, specifications and procedural things conducting control extraction studies and leachable studies. This presentation provides a summary and overview of regulatory requirements for extractables and leachables majorly in Controlled extraction studies, leachable studies for the identification of probable leachables by different instrumental techniques in orally inhaled nasal drug products and opthamalics.