A company recently received this 483 observation:
….. Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product..
Specifically, there is no documentation of the packaging process for … being validated to provide a high degree of assurance that the filling and packaging operations are consistently meeting the drug product attributes.
For more observations pertaining to packaging and labeling, see Issue 1045 available today. It also has observations pertaining to lab controls, manufacturing controls, and medical devices.