Difference between Incidence and Deviation

What is the major difference between Incidence and Deviation?

Deviation:

  • Deviation is taken when a user change or process other than any of written procedure (i.e. Protocol, SOP, Manual Procedure, BMR, Master Documents).
  • The deviation is further divided into two parts:
    • 1. Planned Deviation
    • 2. Unplanned Deviation
Difference between Incidence and Deviation ?

Planned deviation:

  • A deviation from an established procedure, process or method planned prior to execution, is classified as a planned deviation. Planned deviations are not meant to substitute the engineering or documentation change control system. Planned deviations are by definition restricted to a specific period of time or a specific number of batches.
  • Prior to implementation of the planned deviation, the deviation form must be authorized by the respective department & Quality Assurance Head.

Example:

  1. Calibration or Preventive maintenance (PM) shall be performed before or after due date. (Some companies do not allow it after the due date.)
  2. Any parameter deviation in production for any of the purposes in intense evaluation.

Unplanned deviation:

  • The unplanned deviation is a deviation from a standard procedure during the execution of a process, method or procedure that could have an impact on the quality, safety, efficacy, or purity of a drug product, or on the efficiency of a process.
  • All deviations must be thoroughly investigated and documented and will require corrective or preventive action. Deviations observed as a result of incidences shall be covered under unplanned deviations.

Examples:

  1. Deviation of SOP by mistake.
  2. HPLC Calibration or Gas Chromatography calibration due date overdue.
  3. Personal Oversight.

Related: Gas Chromatography Columns

Planned deviation and unplanned deviation shall be further classified on the basis of impact as

  • Critical,
  • Major and
  • Minor deviation.

Critical: A deviation that has substantial potential to have an adverse impact on the safety, identity, strength, quality or purity of a product or produce a product that is not in accordance with the specifications or quality requirement.

Major: A deviation that may have an impact on the safety, identity, strength, quality or purity of a product or produce a product that is not in accordance to the standard specified but complying Quality Document requirement.

Minor: A deviation that may not have any adverse impact on the safety, identity, strength, quality or purity of product, it is due to a departure from approved procedures.

Incident/Event:

  • Normally incidents are taken in the Analytical department or Quality Control department. It is an unplanned occasion that exceeds limits, specifications or expectations described in the written procedure.
  • Incident can be covered in Deviation. (Many companies only have Deviation)

Example:

  1. Personal Oversight

Note: Difference between Incidence and Deviation are listed, if you have further please add a comments.

Read More:

More Section to Read:

Reference:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

You cannot copy content of this page