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Critical Deviation
Deviation from cGMP requirements and/or current regulatory expectations that pose serious and significant risk to product quality, patient safety, data integrity or a combination/repetition of major deficiencies that indicate a critical failure of systems. For example, Manufacturing instructions not followed, wrong batch details printed, SOP or method not being followed during analysis, etc.
Major Deviation
Deviation from cGMP requirements and/or current regulatory expectations that provide a potentially significant risk to product quality, patient safety or data integrity or could potentially result in significant observations from a regulatory agency or a combination/repetition of ‘other’ deficiencies that indicate a failure of system(s). For example, Line clearance is not taken from QA before starting a new batch, price printed on starter pack etc.
Minor Deviation
Observations of a less serious or isolated nature that are not deemed Critical or Major, but require correction so that they do not turn major in future, or suggestions given on how to improve systems and procedures that may be compliant but would benefit from improvement. For example, Manometer readings in sampling booths crossed action limits, signature missing in the manufacturing record, transcription errors, etc.
