You can find the information of stability chamber qualification from the viewpoint of regulations (guidances), operations and issued 483s. 41+ Years Subject Matter Expert (SME) of the stability chamber management in the US Fortune 100 and 500 Pharma Company, Mr. Gary Ostermiller has shared his experience as below.
Through the articles, you will be able to make sure what to do more or less about your current chamber qualification process and this means you can optimize it into much more cost/risk effective one. If you have any questions or concerns about your specific needs, please feel free to contact us firstname.lastname@example.org
User Requirements Specification – URS
Design Qualification – DQ
Installation Qualification – IQ
Chamber Qualification / 483
FDA 483 Tips #2