The FDA issues form 483 ("483") to tell a company exactly which areas to improve or correct to remain compliant, and it can even lead to product recalls, including drugs already on the market.
To remain compliant, and therefore, operational, quality control during each step of drug development and production is essential. A key ingredient throughout the drug pipeline is water; the quality control of water must be as stringent as possible so that it can be immediately eliminated as a root cause when issues such as contamination arise.
Download this white paper about how water quality can help your lab be FDA-compliant by learning about the following:
- What is a 483?
- What is the classification and procedure for drug recalls?
- Why do drugs get contaminated?
- What are the guidelines for helping prevent contamination and non-compliance? Where does water fit into this?