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Deviation in pharmaceutical industry measure the difference between observed value and expected or normal value of a process or a product.
Deviation is categorized as planned deviation and unplanned deviation
Planned deviation:
Planned deviation means pre approved deviation, we know before it occurs. Planned deviation shall be approved before execution. For example, timeline extension for a process completion.
Unplanned deviation:
Unplanned can be defined as departure from written procedure or previously approved process. It may the unexpected or uncontrolled event during performing the procedure or operation any stage of manufacturing, packaging, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.
Deviation can also be categorized as Minor, Major and Critical based on the impact on the quality
Minor Deviation:
When the deviation does not affect the safety, identity, strength and purity or minimum impact on quality attribute, or critical process parameter, or an equipment or instrument critical for process or control, it would be categorized as Minor. For example, room condition outside the limt.
Major Deviation:
Moderately impact on quality attribute, a critical process parameter, an equipment or instrument critical for process or control, the deviation is categorized as Major deviation. For example, sieving is not perform right way, addition order is not correct etc.
Critical Deviation:
A substantial potential quality attribute, aameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel or environment) is highly probable, including life threatening situation, the deviation is categorized as Critical. For example, API mixup, wrong API dispensed etc.
