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SOP on Handling of Incidents and Deviations

  • PROCEDURE:

    • Definition: Departure from an approved instruction or established standard.
    • Deviation shall be lodged when deviation from the written procedure is observed / taken from following documents (but not limited to):
      • SOP
      • BMR
      • BPR
      • STP
      • SPEC.
    • No deviation is permitted from Pharmacopoeia and other Regulatory specifications. However additional steps for betterment to pharmacopeial standard will not be treated as deviation.
    • In circumstances when it is not possible to follow the approved procedure, or an error has occurred (Incident), in such cases deviation must be raised in the prescribed deviation control format by the initiator.
    • The initiator must specify the deviation taken, the stage of operation in the deviation control form and forward it to the department Manager for review. If required additional sheet shall be attached.
    • The deviation form shall have the following information:
      • Deviation Number, date, initiator department, allotted by QA
      • Nature of Deviation (Planned/Unplanned)
      • Deviation Detail
      • Material / Product / Procedure, Code, Batch Number, if any.
      • Preliminary investigation
      • Root Cause
      • Justification for deviation
      • Corrective Action / Steps.
      • Actions / Steps to Avoid Re-Occurrence
      • Impact Analysis
      • Comments of Other Affected Department
      • Comments of Plant Manager
      • Comments of customer / contract giver (If required)
      • Recommendation and Final Approval by Manager Quality Assurance
      • Categorization of Deviation
      • Compliance of Recommendations
    • Deviation Control Numbering System for Planned & Unplanned Deviation :
      • The deviation number consists of eight alpha numeric characters, where first character denotes type of deviation i.e. ‘P’ (Planned) / ‘U’ (Unplanned) second character is ‘-’ , next two characters denoting the year. Fifth character is ‘-’ and next three characters are serial number starting from ‘001’from the beginning of every year.
      • Example: The first planned deviation in the year 2018 shall be numbered as P-18-001 & first Unplanned deviation in the year 2018 shall be numbered as U-18-001
    • Deviation may be planned or unplanned, if there is any deviation is observed then it should be categorized as minor, major or critical. The concerned department does the preliminary investigation (if required).
    • Root cause for deviation is to be identified and mentioned which gives main reason or justification of deviation occurrence.
    • The department Manager must review proposed corrective actions, along with the actions or steps taken to avoid the reoccurrence of the same in future.
    • Impact analysis shall be performed and documented in the relevant section of the deviation control form by impacted department Manager / other departments / QA. Recommendation of the impact analysis shall be duly endorsed by the Manager of the impacted departments.
    • QA will forward the deviation to other affected department for their comments (If required).
    • If required comments of any department which is available outside the plant, deviation should be forward to respective department through scan copy / hard copy / any other communication mode. Signed scan copy should be attached with deviation (If required).
    • R&D Manager must review the form for the impact in coordination with the relevant department and give his recommendations.
    • Based on the review, Plant Manager must give his / her comments to avoid such deviation in future.
    • QA will forward the deviation to customer / contract giver for their comments / review through scan copy / hard copy / any other communication mode (If required). Signed scan copy should be attached with deviation (If required).
    • Manager QA/ Designee shall approve the deviation only if it is justified and the corrective actions / steps for preventing reoccurrence are satisfactory and the deviation does not have any impact on the Strength, Identity, Safety, Purity and Quality of the product and categorize as given below:
      • Minor Deviation: Having no significant impact on product quality and / or safety.
      • Major – Having significant impact on product quality and / or safety.
      • Critical – Having Significant impact on product quality and / or safety and likely to have a serious and a harmful effect on the patient.
    • In case of non-approval of the un-planned deviation by the Manager QA, the batch in question shall not be processed further and the recommendation of the Manager QA shall be followed for further processing / rejection.
    • In case the final disposition of the planned deviation is not done (i.e. neither approved nor rejected) within seven days of allotment of number from QA, the deviation shall be invalidated and a fresh deviation is required to be filled if needed.
    • The deviation shall be closed after implementation and compliance of all the recommendations mentioned in the impact analysis.
    • The person / department initiating the deviation shall be responsible for compliance of all the recommendations written in the deviation control.
    • Quality Assurance shall maintain the list of deviations occurred / planned during the year.
    • The deviation control should be closed normally within 30 working days from the approval of the deviation. In case this is not done, the initiator department has to submit justification with the approval of Manager QA.
    • Product specific deviations should be closed before release of batch. Copy of the deviation should be preserved with respective batch record.
    • Trend Analysis:
      • Trend Analysis of deviations should be performed in start of the next year by the QA department in the calendar year
      • Deviation should be preserved up to expiry + 1 year (Product specific) or 05 years whichever is earlier.
      • Product specific deviation shall be listed in APQR.