Critical observation definition
Critical observation means an observation describing a situation that will most likely result in a non-compliant product or a situation that may result in immediate or latent health risk and any observation that involves fraud, misrepresentation, or falsification of products or data;
Critical observation means any non-conformance, which can affect the purity, strength and safety of the medicines that pose a serious health risk to the users or potentially life threatening.
Critical observation means a significant and meaningful GMP deviation or deficiency that requires immediate remediation.