SOP FOR Deviation Control

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  • OBJECTIVE:

To lay down the procedure to describe the steps to be followed in case of planned/unplanned deviation from the standardized activity, standard procedure.

  • SCOPE:

This procedure is applicable for handling of deviation for approved procedures and processes

  • RESPONSIBILITY:
    • Initiator: The affected department’s responsible person (initiator) is responsible for intimating QA about deviation, handling the deviation, conducting the investigation and taking the appropriate corrective actions.
    • Initiator department Head: Assess the necessity to inform QA or other department involved in the deviation immediately following the discovery of the deviation.
    • QA: Assess and evaluate investigation together with involved departments and complete the deviation report.
    • Head – QA: To assess the details of investigation and give the acceptance to the decision for the deviation.
  • ACCOUNTABILITY :

Department Head and QA Head shall be accountable for compliance of the procedure mentioned in this SOP.

  • ATTACHMENTS :

Deviation Control Form                                          − Attachment-I

Deviation Log Book                                               − Attachment-II

  • PROCEDURE :
    • Deviations are of two types: Planned & Unplanned.
      • Planned Deviation: Any Deviation in the procedure, process, equipment, standard batch size which is planned, documented, assessed for its impact on product quality and authorized in advance, with the agreement of all concerned is termed as planned deviation.
      • Unplanned Deviations (Unforeseen Deviations): While carrying out day to day activities, there are chances of unplanned deviations and events to occur. These deviations are unforeseen, accidental and shall occur due to several reasons like:
        • Equipment failure / breakdowns/malfunctioning
        • Power Supply failures / Interruption
        • Accident/ Mishap in the plant.
        • Breakdown in support services/ utilities
        • Any other unforeseen situation (e.g: Production process parameters, HVAC system, Water system,

equipment / instrument calibration, environment control, storage conditions, analytical test procedures etc.)

  • For any planned deviation, it needs to be authorized by Head QA in writing.
  • For any deviation, intimate to QA with intimation slip for issuance of Deviation Control Form.
  • QA to issue the form with a serial number as DV/SCT/XX/YYY, where

DV- denotes Deviation,

SCT- denotes Sano Cito Therapeutics Inc.,

XX – two last digits of the year,

YYY – Serial number.

  • Category for deviation
    • Critical – A deviation that provides immediate and significant risk to the product’s SQIPP and represents marketed product, or a combination/repetition of major deficiencies that indicate a critical failure of system(s).
    • Major – A deviation that provides significant risk to the product’s SQIPP, but does not represent marketed product, or could potentially result in significant observations from a regulatory agency, or a combination/repetition of minor deficiencies that indicate a failure of system(s).
    • Minor – a deviation that does not impact the product’s SQIPP and is of a less serious or isolated nature that may require correction
  • The initiating department has to write the description of deviation. QA should give immediate action to be taken on the deviation. Initiator department should give root cause for the deviation & justification of the same.
  • The form has to be forwarded to QA where the Head of QA looks into it through risk assessment to evaluate the impact of deviation on the quality of other product.
  • The QA Head also looks into the regulatory aspect of it & based on it gives acceptance to the deviation.
  • The QA Head should discuss with the initiator department’s head for requirement of any CAPA to avoid recurrence of the same and decision for disposition to be taken.
  • All of the above has to be recorded in the Deviation Control form with respective signatures.
  • The investigation of the deviations shall be completed within 30 calendar days. If not completed, then interim report justifying the delay to be prepared every 30 days until the investigation is closed.
  • The original Deviation Control form remains with QA & a copy given to the initiator department to attach it with the concerned records (if required).
  • Trend analysis evaluation and graphical representation of analytical data

Statistical analysis should be performed to assess the nature of deviation. Since the investigation is performed, graphical representation of description of deviation (i.e. Planned or Unplanned) will be useful to study the historical patterns of deviations and aid in the visual evaluation trends that may translate in abnormal variations. Individual trends shall be analyzed and conclusion shall be written.

  • Recommendations and conclusion

All data included in section 6.1 should be evaluated as a whole and these data should be        summarized and recommendations for actions provided. The responsibility for coordination and supervision of follow-up measure is with the QA.

  • REFERENCES:

In-house

  • ABBREVIATIONS:

QA: Quality Assurance

HVAC: Heating, Ventilating and Air conditioning

CAPA: Corrective Action and Preventive Action

SQIPP: Safety, Quality, Identity, Potency, Purity

  • DISTRIBUTION LIST :

Quality Assurance

Quality Control

Production

Engineering

Warehouse

10.0     HISTORY OF REVISION:

Version No. Effective Date Reason for Revision

 

SOPs