If you’re seeing the same deviations pop up (gowning fibers in the dryer room, unexplained assay drift after solvent changeover, or audit trails with gaps, for example), then it’s not necessarily a “people performance problem“ alone. Rather, it may suggest that depth in the root-cause analysis (RCA) within the investigation process may also be an […]
In the quest for effective treatments for their disease, cancer patients often require several different modalities and treatment types. Radiopharmaceutical products are one of those forms of treatment, and treatment with these types of products requires expedient delivery to ensure that the required dosage is administered to patients as radioactive decay may result in a […]
When a firm receives an FDA 483 finding of “does not follow Standard Operating Procedures (SOPs) for performing X GMP activity,” the immediate response is often to revise or update that specific SOP with more detailed instructions. While this might seem like the right thing to do for a quick fix, it is crucial to […]
Investigations have historically been among the most commonly cited observations in FDA 483s so a robust investigation strategy is an important element of any firm’s quality program. A strong investigation is supported by a thorough and complete evaluation of the major elements: root cause analysis, impact assessment and scope, historical analysis, establishment of CAPAs, and a […]
Some common FDA 483 citations pertaining to cleaning validation are regarding consistency in monitoring of cleaning and the complete documentation of cleaning. It is critical to implement a robust monitoring process that is supported by detailed documentation. Ensuring that the SOPs for all aspects of cleaning are clear, detailed, and contain illustrations (where appropriate) to ensure […]
An aspect of contamination control is the assurance that residual material is not carried over into successive batches by incomplete cleaning of equipment. Cleaning procedures (both the cleaning process and the analytical method to verify cleaning effectiveness) to provide this assurance should be validated. Sampling of equipment for the purpose of cleaning validation or cleaning […]
