AIChE October 2019 Newsletter | AIChE

AIChE October 2019 Newsletter

We will be presenting the current Good Manufacturing Practices (cGMP) per the Food and Drug Administration (FDA), and how these directives are practiced in a pharmaceutical manufacturing facility making parenterals in a Final Dosage Form (FDF). This process operation has the strictest regulations from the FDA relative to any other production areas. This is due to the direct injection of the parenterals into the human blood stream with no barriers of protection from any potential risk of contaminants or pyrogens that may cause fever or infection.