Handling of Deviation – SOP

By / Quality Assurance / QA, SOP /

SOP for Deviation Handling in Pharmaceutical Industry | Handling of Deviation SOP in Pharma | Deviation Management SOP |

  • Deviation SOP covers below points:
    • Deviation definition Types of Deviation
    • Unplanned Deviation
      • Examples of unplanned Deviations
    • Planned Deviation
      • Examples of planned Deviations
    • Deviation form contents
    • Minor Deviation
      • Examples of Minor Deviation
    • Major Deviation
      • Examples of Major Deviation
    • Approval / Rejection of Deviation
    • Deviation form numbering system
    • Deviation closing system
    • Maintaining Deviation documents
    • Deviation format / Deviation form format
    • Extended Review of Deviation format
1.0 OBJECTIVE :
  • To describe a procedure for handling and control of deviations which may occur during any activity, executed in the facility.
2.0 SCOPE :
  • This SOP is applicable for any deviation in the facility, product, manufacturing, analysis, documents.
3.0 RESPONSIBILITY :
  • Chemist and above are responsible for ensuring that their action regarding compliance of the Deviation.
  • Head of all departments are responsible to ensure that this SOP is followed.
4.0 ACCOUNTABILITY:
  • Q.A. Head
5.0 PROCEDURE :

Deviation is a departure from an established standard.  Deviations may be anticipated (planned) or unanticipated (unplanned). Deviation may have the potential to affect the identify, safety, purity and efficacy of the product.

5.1 The established standard include but not limited to;

  • Master Formula Record,
  • Batch Manufacturing Record and Batch Packaging Record,
  • Hold time of product during process,
  • Raw Material or Packaging Material Specification,
  • Analytical Methods,
  • Water Monitoring Procedure,
  • Air Monitoring Procedure,
  • Equipment calibration Schedule,
  • Equipment Preventive Maintenance Schedule,
  • Any other processes/procedure affecting product quality.

5.2 Unplanned Deviation: While carrying out day-to-day activities, there are chances of deviations from written and established procedures. These deviations are unforeseen, accidental and shall be due to several reasons mentioned below, few examples which comes under unplanned Deviations,

  • Equipment failures / breakdowns / malfunctioning,
  • Power supply failures / interruptions,
  • Accident / mishap in plant,
  • Unsafe conditions / act,
  • Breakdowns in service lines / Utilities,
  • Lack of awareness / negligence,
  • Non critical failures,
  • Any other unforeseen situation.
  • During unplanned deviation, the officer/ operator / workman deputed for their job shall inform to supervisor within 24 hours. As per the severity and stage, process may be stopped.

5.3 Planned Deviation: Another type of deviations which are well planned in advance, known deviations from the set standards or procedures on timely need basis, for example;

  • Calibration or validation is not carried out as per schedule due to delay for various reasons,
  • Use of material from unapproved vendor,
  • Change in batch size,
  • Change in equipment,
  • Change in packing quantity.

5.4 Action taken by originating department:

  • The deviation in the above cases shall be informed by respective supervisor / In-charge to officer and above of Quality assurance department. After getting satisfied the reason Quality assurance officer will issue the blank working copy of  deviation format by assigning deviation number and also acknowledgement from the originating department on format issues register. The initiator shall fill the details like following.
  • The Deviation form has the distinct elements:
    • DEVIATION APPLICABLE FOR:
      • The initiator describes the applicable detail of Document/System/ Method/Equipment/Instrument/Facility/Product/Process/material/Specification and also mention title and relevant document no./Protocol No./Equipment No./Instrument No./Batch No. A.R.NO./Item Code.
    • NATURE OF DEVIATION:
      • The initiator should describes whether the deviation is planned/unplanned.
    • CURRENT PROCEDURES:
      • The initiator should describes the current procedures of Document/System/Facility/Product/Process/material/Specification Method/Equipment/Instrument.
    • DESCRIPTION OF THE DEVIATION:
      • The initiator should describes the details of Document/System/ Method/Equipment/Instrument/Facility/Product/Process/material/Specification.
    • JUSTIFICATION FOR PLANNED DEVIATION / INVESTIGATION OF UNPLANNED DEVIATION:
      • The initiator describes the investigation/justification for the deviation in detail. All documents and equipment affected must be listed on the deviation form. Attach copies of all impacted documents, highlighting the deviation.
    • INITIATED BY:
      • Name and department with sign and date to be mentioned.
    • COMMENTS BY HOD (Initiating department):
      • The initiating department head will describe the comments related to Document/System/Instrument/Facility/Product/Process/material/Specification Method/Equipment whether its give impacts on safety, efficacy and quality of products.
    • ROOT CAUSE:
      • Root cause analysis shall be carried out for all major unplanned deviation, by originating Department Head and Quality Assurance and copy of the root cause analysis shall be attached to the deviation form.
    • CORRECTIVE AND PREVENTIVE ACTIONS BY HOD-INITIATING DEPARTMENT:
      • Concerned department head & Quality assurance head or his/her designee shall carry out further action plan for preventive measures to be taken. This is to avoid the recurrence of such deviation in future. This may be done in consultation with the Engineering department depending upon the nature of deviation and its reasons.
      • The corrective action and preventive action shall be implemented by the originating department after approval of the deviation.
    • EVALUATION OF INVESTIGATION SUMMARY, ROOT CAUSE ANALYSIS, CAPA APPROVAL OR REJECTION (BY QUALITY ASSURANCE HEAD):
      • Quality Assurance head shall review the process – deviation and shall evaluate its impact on the products quality attributes in consultation with concerned head. The deviation form and recommended CAPA and its impact assessment shall be reviewed for adequacy by Quality assurance head.

5.5 Based on the investigation and impact assessment, Quality assurance head shall categorise the deviation as major or minor.

  • Minor Deviation: Any deviation which may not have any impact upon the identity, quality, purity, stability, physical characteristics, safety and efficacy of the product or process is a minor deviation, for example;
    • Use of stereo height of 1.5 mm instead of 1.25 mm,
    • Use of different type of tertiary packaging material code e.g. plain carton /  Corrugated box,
    • SOP not made effective as per standard effective date,
    • Spillage of material during dispensing, processing,
    • Use of 5 ply Corrugated box instead of 7 ply Corrugated box.
  • Major Deviation: Any deviation which may have an impact upon the identity, quality, purity, stability, physical characteristics, and efficacy of the product or process is major deviation, for example;
    • Dust /powder observed adhered to cleaned accessories, containers,
    • Use of different machine/equipment of different principle,
    • Equipment breakdown during activity running,
    • Average weight of Tablet/Capsule is out of limit,
    • Wrong status labeling.

5.6 APPROVAL / REJECTION OF DEVIATION:

  • Decision regarding approval /rejection regarding the deviation shall be taken by Quality assurance head.
  • Technical Head/Director shall decide for need of customer approval.
  • All supporting data related to the deviation should be attached to the deviation form. All the E-mails / communications related to the deviation are attached in the form.
  • If any planned deviation is rejected, it should be termed as ‘cancelled’ and same should be updated in the remarks column in the deviation log book.

5.7 CHANGE CONTROL INITIATION (IF REQUIRED):

  • If the deviation triggers any type of change control, then it has to be mentioned with description.

5.8 DEVIATION FORM NUMBER:

  • The deviation Number  should be assigned as follow,
    • DCR/00/000
      • Where,
      • DCR: Deviation Control Request
      • 00: Year in which deviation occurred
      • 000: Serial number of Report

5.9 CLOSURE DATE:

  • For major deviation, close out period shall be 30 days from logging the deviation and for minor deviations, the close out period shall be 15 days.
  • Close out date should be entered in the deviation form by Quality assurance head with signature after final review of the deviation and close out comment. The same should be recorded in the deviation.

5.10 Any close out exceeding this period shall be recorded as extended in the remarks section in the deviation log book and should undergo a review process as per Extended Review Deviation.

5.11 For deviations where root cause /investigation is not completed within the period specified, justification for not closing out, the status should be mentioned as 1st review. In case the deviation exceeds 30 days of 1st review, the further status and action should be mentioned in the 2nd review giving justification for not closing out. Further if investigation is not completed within 30 days of 2nd review, then the status and further action should be mentioned in 3rd review giving justification for not closing out. Further if investigation is not completed within 30 days of 3rd review then it should be reported to Quality assurance head for further advice.

5.12 If the deviation is not ‘closed’ within six months then the Originating Department Head, along with Quality Assurance Officer in coordination with Quality Assurance Head shall evaluate the justification/investigation with the impact assessment and after final review of deviation by Quality assurance head, Quality assurance head shall decide for the close out of deviation.

  • Various types of possible deviations which may be encountered are;
    • Failure to meet regulatory specifications (e.g. Assay specifications as mentioned in official monographs) and in-house specifications.
    • Unusual appearance of raw and packaging components, beyond acceptance Quality level.
    • Unsatisfactory appearance of formulations.
    • On line rejections.
      • Approved materials, which are required to be rejected during processing, ‘On Line Rejection form’, shall be raised with necessary details and actions taken as per SOP for handling on line rejection.
    • Extended process duration.
      • For extended process duration in processing time or analysis time, justification shall be given in the form ‘Manufacturing lag time deviation record’ for various manufacturing sections.
    • Change in established method.(e.g. alterations in charging sequence).
    • Temporary planned changes in secondary packing components.
    • Altering the original batch size.
    • Correcting printed or typographical errors on formats.
    • Separate methods of analysis for same ingredients (e.g. analysis of Vitamins by chemical analysis or using HPLC).

5.13 MAINTAINING OF DOCUMENT:

  • The original copy of the deviation form and the deviation log shall be maintained for 5 years for traceability and the document are destroyed after 5 year by Quality Assurance Department.
  • Supporting data for deviation, investigation should be attached to the deviation form.
  • A photocopy of the deviations occurred related to product/batch shall be kept along with the respective batch document after completion of investigation and immediate corrective action. The photocopy can also be given to concerned Department.
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
SOPStandard Operating Procedure
Q.A.Quality Assurance
MMMillimeter
CAPACorrective Action Preventive Action
HPLCHigh Performance Liquid Chromatography

7.0 ANNEXURES:
Annexure No.Title
01Format For Deviation Form
02Format For Deviation Control Register
03Format For Extended Review of Deviation

8.0 SOP REFERENCES
  • GMP Guidelines

END OF THE SOP

ANNEXURES :

Annex. No. 01 Format For Deviation Form

Annex. No. 02 Format For Deviation Control Register

Annex. No. 03 Format For Extended Review of Deviation