Let’s ask the questions; Does it need to be validated? What is involved in the process of selecting and installing a new temperature monitoring program? Does it need to be a full blown system, can I short cut the process? Can I install it or should I have the...
Posts Tagged with Monitoring
Chamber Qualification / 483
Related FDA483/Warning Letter 6, Initial qualification and routine calibration, maintenance and cleaning of automatic, mechanical, and electronic. equipment is not performed according to a written program designed to assure proper’ performance www.fda.gov Initial setup of the unit should include a Design Qualification (DQ) to ensure that the unit is...
Chain of Custody / 483
Chain of Custody is the documentation of your samples lifecycle history. Most people don’t realize that Chain of Custody starts very early in the manufacturing process and continue through the testing phase. All stages of a sample’s life cycle have some sort of chain of custody or an inventory...