The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry and FDA Staff - Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

Origin/Publisher:

FDA, http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM346181.pdf

Content:
This guidance identifies additional, technical information that should be submitted by sponsors who seek to rely on conformity to ISO 11040-4 for a glass syringe product.

Go back

GMP Conferences by Topics