Handling of Deviations Control in Pharmaceuticals

SOP on “Deviation Control Procedure”

Deviations Control in pharmaceutical has been described as below in,

Objective:

  • This standard operating procedure (SOP) describes the procedure for identifying, investigating, documenting, and reviewing any deviations from the written procedures and taking corrective actions and preventive actions (CAPA) for preventing of reoccurrences in the future.

Scope:

  • This SOP is applicable to all procedures, processes, parameters, systems, and incidences leading to direct or indirect impact on the quality of materials, products, regulatory submissions, stability, Validation, Major equipment/Instrument breakdown etc

Definitions:

  • Planned deviation: A deviation from an established procedure, process or method planned prior to execution, is classified as planned deviation. Planned deviations are by definition restricted to a specific period of time or specific number of batches. Prior to implementation of planned deviation, the deviation form must be authorized by the respective department, Unit Head & QA Head/Designee.
  • Unplanned deviation: 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
  • 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 which is not in accordance with the specifications or 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 with the requirement.
  • Minor: A deviation that may not have any adverse impact on the safety, identity, strength, quality or purity of the product, it is due to a departure from approved procedures.
  • Corrective Action: Action(s) taken to resolve or correct existing non-conformity, investigate to identify the root cause, address the identified root cause(s), and I or eliminate the cause(s) of existing incident/Deviation (non-conformance, problem, etc.).
  • Preventive Action: Action(s) taken to eliminate the root cause(s) of potential incident/Deviation, defect of undesirable situations to prevent future non-conformance.

Procedure for handling the Deviation:

  • Deviation is defined as an activity that is carried out differently or modified from what is indicated in an approved document.
  • For any departure from the below-mentioned cases, a deviation shall be filled by the concerned person immediately and not later than 24 hours.
  • Any incidence leading to direct or indirect impact on quality of materials, products, regulatory submissions, GMP Compliance shall be deemed as deviations. Departure from written standard procedure, Online Raw material / Packaging material rejections, non-compliances to environmental standards beyond a predefined limit, Material / Product mix up, Additional raw material requirement, Major equipment break down, Product not meeting validated process parameters Deviation shall be classified into two categories, namely, planned and unplanned deviation.
  • Planned deviation: A deviation from an established procedure, process or method planned prior to execution, is classified as planned deviation.
    • Any deviation in Documented process/procedure/testing procedure / operating/calibrating procedure, equipment, operating environment or any other critical process which is pre-planned shall be known as planned deviation (Development procedure shall not be covered in deviation).
  • Unplanned deviation: 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.
  • While carrying out day-to-day activities, there are chances of unplanned deviations (unforeseen deviations) and events to occur. These deviations are unforeseen, accidental and may be due to several reasons like (but not to limited);
  1. Equipment failures / breakdowns / malfunctioning / Process Failures
  2. Power supply failures/interruptions
  3. Accident / Mishap in the Unit
  4. Breakdown in support services/utilities
  5. Documentation Failures
  6. Analytical Failures / Errors
  7. Incidents
  • Planned deviation and unplanned deviation shall be classified on the basis of impact as Critical, Major and Minor deviation.

Deviation Control form handling Procedure:

  • Concerned user department shall issue the Deviation Control form from the QA. The Deviation Form (Refer attachment-1) by performing the following:
    • Enter a tick mark for Planned or Unplanned deviation.
    • Do not enter a tick mark for Critical, Major or Minor, this will be done by the QA.
    • Describe the nature of the deviation by providing a short summary of what occurred and immediate concerns associated with the deviation.
    • Describe the details and reason of the deviation for the deviation by providing a short description of circumstances that led to the occurrence as per Attachment- 1
  • QA will log the Deviation No. in log and assign the Deviation No.
  • Numbering System of Deviation No. will be as “DX/AA/YY/ZZZ

Where;

  • DX: D denoted for Deviation, X: P for Planned Deviation, U for Unplanned Deviation.
  • AA: Initiating Department
  • YY: Current Year
  • ZZZ: Sequential No. starting from 001.

  • Once it completed, the concerned user will forward the deviation form to the respective Section in charge / Department Head (HOD).
  • They shall review the deviation detail and shall evaluate for nature of deviation as Critical / Major / Minor with QA and accordingly shall put the tick against the respective box in it.
  • In case of unplanned deviation is observed during the night period or on holiday, the person shall inform to respective section head in consultation and approval from QA shall inform/guide for required action. The deviation form can be filled out and authorized on the subsequent working day.
  • QA will enlist the concerned department for quality impact to other departments. Signature for same shall be taken for impact evaluation.
  • Unit Head shall approve (In case of Planned Deviation) and make a comment for Deviation.
  • Based on the nature of deviation, the Section in charge / Department Head shall discuss with the concerned people in the department and work out corrective actions.
  • The Section in charge / Department Head shall record the corrective actions in the form with his signature and date.
  • Based on the corrective action mentioned in the form, User Department shall record the suggestions for the preventive actions in the form with signature and date. If no preventive action is required, then write “Not Applicable or NA”.
  • Once the appropriate corrective actions and preventive actions are determined, it shall be executed as earliest as possible
  • Deviation form shall be forward to listed departments which is critical in nature for prior approval.
  • Initial timeline shall be given by the user department.
  • In case the deviation is not approved, the involved batch/batches, if any, shall be rejected.
  • After verifying the CAPA and Deviation activity User Department will initiate for Closeout of Deviation.
  • QA will enlist the supporting document for close out of Deviation Control form.

Deviation Control Form:

Deviation Form-SOP on Deviation Procedure
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Deviation Form-SOP on Deviation Procedure
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Deviation Form-SOP on Deviation Procedure
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Related: SOP on SOP, Difference between Incidence and Deviation

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Reference:

USFDA Guidelines

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