Differentiation between Deviation and Incident in pharmaceutical GMP manufacturing facility.
Deviation is departure from the written procedure, incident there is no procedure, it is basic understand, but not knowingly happen, ie material spillage, Issueance of wrong material while dispensing,using of obsolete documents.
Deviation: Any non-conformance / disobeyance in written approved procedures of quality system in the organization.
We have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and works against this, then it is called deviation. It means deviation from any written procedure that we have implemented.
Deviation can be of two different types:
Planned Deviation : Any deliberate or intentional non-conformance or deviation
Planned prior to the execution of an activity, which is to be undertaken following documented, justifiable and approved rationale.
Any departure from established and approved procedures observed or noticed prior to the execution of an activity, such as SOPs, STPs, processes, systems, standards and protocols, which is done under compulsion or for continuous quality improvement programs will be categorized as planned deviation.
For example: Calibration or validation is not carried out as per schedule due to delay for various reasons.
Unplanned Deviation :An accidental or unanticipated non-conformance or deviation observed or noticed during or after the execution of an activity. An unplanned deviation can be a critical or major or minor in nature.
For example: deviation in failure of procedure, utility, material, equipment or any system is occurred. We can consider it as any change from the previous or our written procedure.
While carrying out day-to-day activities, there is a probability of unplanned deviations (unforeseen deviations) occurring. Such unexpected events may be related to any procedures, processes, systems, equipment and utilities. These deviations may occur for many reasons, such as following (not all inclusive):
Equipment failure / Breakdown / Malfunctioning.
Power supply failure / interruption.
Accident in the plant.
Breakdown in support services / utilities.
Laboratory failure / Error.
Unplanned deviations may be critical, major or minor. These can be categorized on their impact of product quality.
Critical Deviation : The deviation is likely to or will have a significant impact on critical attributes of the product.
For example: Manufacturing instructions are not followed, wrong batch details are printed, SOPs or methods of testing not followed during analysis etc.
Major Deviation : The deviation could or may have a significant impact on critical attributes of the product.
For example: Raw material is received in a damaged container, manometer readings in the sampling booth are crossed the action limits etc.
Minor Deviation: The deviation is unlikely to have a detectable impact on critical attributes of the product.
For example: Line clearance is not taken from QA, physician sample wrongly printed with price e
Incidence : Any event that may or may not affect our product quality but that is against the cGMP.
For example: someone is found without gowning in the production area or any insect is found in granulation area. These may have impact on product quality but not every time, sometime it will not impact. These are the deviations from GMP but difference is that these are not related to our manufacturing process. So these will not be categorized as deviations.
Some other examples of incidence: Eating food in production area, spillage of material on floor, break down in any machine during processing, wrong material added in batch, mix-up of two batches etc.