incidence and devation

Planned and Unplanned deviation

Difference between Incidence and Deviation?

There is only a minor difference between Incidence and Unplanned Deviation.

Incidence: Any event which is occurred due to failure of the any activity which is not in written form but is a basic need to complies cGMP is known as incident.

All the incidence should be recorded, as it can needs to be retrieved later as part of an investigation.

Ex-Material Spillage, Machine breakdowns due to power failure or short circuit,

Same Material of different A.R. No. issuance during dispensing.

Deviation: Any departure from written procedures (SOP, Protocols, STP, BMR/BPR etc.) is called deviation.

Deviation Categorization

Deviations are of two types:

Planned deviations

Any departure from written standards and procedures. Which we know before they occurred. Pre-approval from different cross functional departments needs in this type of deviations.

Unplanned deviations

 Any departure from written standards and procedures. Which is unknowingly occurred. Unplanned deviations are further categorized in minor, major and critical deviations.

  1. Minor Deviations When the deviation does not affect any quality attribute, a critical process parameter, or an equipment or instrument critical for process or control, it would be categorized as Minor deviation.

   Examples:

  • Skip of FEFO principle (first expired-first out) in raw material handling.
  • Balance out of tolerance used to determine gross weight of raw materials upon reception.
  • Pressure differential out of established limits in class D washing area.
  • Inadequately trained personnel to perform warehouse cleaning activities.
  1. Major Deviations When the deviation affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel/environment) is unlikely, the deviation is categorized as Major requiring immediate action, investigation, and documented as such by the appropriate SOP.

Examples :

  • Use of unapproved reference standard to test an API or drug product.
  • Inadequately trained personnel to perform sterility tests.
  • Production started without line clearance.
  • Filter integrity test has been carried out using equipment with no documented installation qualification completed.
  • Gross misbehavior of staff in a critical aseptic process.
  • Pressure differential out of established limits in aseptic fill areas.
  • Untrained personnel responsible for segregating the approved and rejected raw material in the warehouse.
  1.  Critical Deviations When the deviation affects a quality attribute, a critical process parameter, 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 requiring immediate action, investigated, and documented as such by the appropriate SOP.

   Examples :

  • Expired or rejected API component used.
  • Sterilization record of product-contact material used in aseptic filling process not available or unacceptable.
  • Incomplete inactivation stage of fermentation.
  • Temperature out of control limit during detoxification stage

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