HW 14

1. Go to: https://www.fda.gov/default.htm

2. Find box titled “Regulatory Information”

3. Click on “Guidance Documents”

4. In search box, type “sterile drug products”. No need to press enter as it instantaneously searches.

5. Scroll down on the result table and click on the search result related to aseptic processing.

Summarize highlights of part V of the guidance - Personnel training, qualification, and monitoring, part VI - components and container/closures, and part VII - endotoxin control,