Certain Risk 2 observations may be upgraded to Risk 1 Major observation (Risk 2) : Observation that may result in the production of a drug not consistently meeting its marketing authorization.Critical observation (Risk 1) : Observation describing a situation that is likely to result in a non-compliant product or a situation that may result in an immediate or latent health risk and any observation that involves fraud, misrepresentation or falsification of products or data.HC-SC-GC.ca :- Summary report of the Drug Good Manufacturing Practices (GMP) Inspection Program All Risk 3 observations could be upgraded to Risk 2. "Other" observations are not listed as such (Observations that are neither critical nor major are considered as "other" and will be assigned a Risk 3). Other observation (Risk 3): Observation that is neither critical nor major but is a departure from the GMPs.Certain Risk 2 observations may be upgraded to Risk 1. Refer to Appendix 1 for the list of observations that are considered major and which will be assigned a Risk 2. Major observation (Risk 2): Observation that may result in the production of a drug not consistently meeting its marketing authorization. ![]() Refer to Appendix 1 for the list of observations that the Inspectorate considers critical which will be assigned a Risk 1. Critical observation (Risk 1): Observation describing a situation that is likely to result in a NC product or a situation that may result in an immediate or latent health risk and any observation that involves fraud, misrepresentation or falsification of products or data.HC-SC-GC.CA :- Risk Classification of Good Manufacturing Practices (GMP) Observations (GUI-0023) Several related major or other deficiencies may be taken together to constitute a critical or major deficiency (respectively) and will be reported as such.Īll critical and major deficiencies found will be reported even if remedial action has been taken before the end of the inspection. (A deficiency may be “other” either because it is judged as minor, or because there is insufficient information to classify it as major or critical). Other deficiency :- A deficiency which cannot be classified as either critical or major, but which indicates a departure from good manufacturing practice. ![]()
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