Extractables and Leachables

Guidance documents issued by the Regulatory Authoritiesin the US and Europe outline “best-practise” procedures for evaluation of the primary packaging and delivery devices for pharmaceutical drug products.

Such guidelines indicate that an assessment of the safety and compatability of packaging and closures should be conducted during the early stages of a new drug or formulation.

The assessment criteria vary depending upon the route of administration, with pulmonary and injectable drugs having the strictest requirements.

General guidance is available from the FDA (CPMP)

http://www.fda.gov/cder/guidance

And the EMEA (specific department here)

http://www.emea.eu.int/pdfs/human/qwp/4931305en.pdf

With product specific guidance for MDI’s and DPI’s contained in

http://www.fda.gov/cder/guidance/2180dft.pdf

and NSI’s in

http://www.fda.gov/cder/guidance/4234dft.pdf

Interested in the details covered here, then why not contact us?