During cGMP inspections, one of the most commonly cited observations by the FDA is the inadequate investigation into deviations. Pharmaceutical companies must address this issue to maintain compliance and ensure patient safety. Here are some key points to keep in mind regarding deviation investigations in the pharmaceutical industry: Observation Highlight According to the FDA, many…
CAPA is a fundamental quality management tool for pharmaceutical industry. Implementing an effective corrective or preventive action capable of satisfying regulatory authorities also. Corrective Action The action was taken to rectify, fix or correct a specific deviation, defect or undesirable situation. Preventive Action The action was taken to eliminate the cause of deviation, defect, or…
It causes a big confusion to understanding the occurrence of incidence and deviation in pharmaceuticals. In this article we briefly discuss on types of deviation and management of deviation. Deviation Terminology When we have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and someone works against this, then it is…