The U.S. Food and Drug Administration (FDA) issues Form 483 Inspectional Observations or warning letters when communicating to a pharmaceutical company that its quality practices are not in compliance with regulatory standards. Most of these observations and warnings are caused by the same 10 common mistakes, download the whitepaper to learn more about the common reasons for the warning letters.
Problems and accidents are inevitable if the employees of a pharmaceutical product research organization and/or manufacturer do not have current written instructions for their tasks.
To maintain the integrity of laboratory controls, a company must have a system in place that effectively integrates quality processes such as those critical to change control, audits, and CAPAs.
If a pharmaceutical company is unable to identify potential root causes and make sufficient record of them, their internal investigations will be viewed by the FDA as incomplete.
Don't make these 10 common mistakes.Download the Whitepaper