To describe the procedure for handling of deviations.
This SOP is applicable for any deviation in an established process in all functional areas.
QA Officer /Executive
Head- Quality Assurance
- As for as possible there should not be any
deviation in either manufacturing or packing process. Deviation may be planned
- Planned: Planned deviations are those deviations from the procedure that are planned and we know before they occur.
- Unplanned: In the case of unplanned deviation, the failure of the procedure, utility, material, equipment or any system occurs. We can consider it as any change from the previous or our written procedure.
- A deviation may be defined as departure from an approved instructions. A deviation is an activity which is outside the written down approved standard procedure of an operation/ activity, but may be implemented for completion of that activity/ operation or improve upon product quality, ease of operation, cost effectiveness, time and manpower saving after due impact assessment and approved by QA department.
- All the Deviations shall be reported as and when observed.
- The person who observes the Deviation shall inform the concerned department Head about the deviation for further action.
- Issuance of Deviation format :
- The format of Deviation shall be issued by QA as per the requisition given by the respective departments.
- In case of any additional prints / pages are required respective department shall raise requisition for additional page, QA shall issue additional page after approval of QA Head/ designee.
- The Deviation Report format shall be filled by the concerned
department Officer/ Executive with brief description of the nature of Deviation. The duly filled
deviation form shall be send to Department Head for further evaluation.
- Department head of the initiating department shall review the content of deviation and shall make
opinion. Department head shall send back the format to initiator in case of additional information
required on the deviation.
- Department Head along with the concerned officer shall investigate the reasons for the occurrence
of the Deviation and describe the findings of investigation and record the conclusions in the
deviation report format.
- After review, department head shall make the comments on the deviation and send it to applicable
department for their comments and finally send to QA department for further evaluation.
- On receipt of the deviation, QA Officer shall allot a number to the Deviation report as follows and
shall enter the details in the Deviation Log book.
Where, D- Deviation Report
DC – Department Code
YY – Last two digit of the year
MM- Month (01 for Jan, 02 for Feb………..…12 for December)
XXX – Serial No. of the deviation raised in the respective month.
The first deviation occurring in the Production Department in January 2013 shall be numbered as D/PR/13/01/001.
- Category for Deviation
QA department shall classify the deviation as critical, major or minor as follows:
- Critical: The deviation which
has significant impact on the product quality, termed as critical.Areas such as contamination of APIs (during dispensing,
Manufacturing) critical process parameters, equipment/
instrument performance breakdown, Utility failure, calibration of critical
instruments, equipment cleaning, line clearance, cross contamination etc.
- Major: The deviation which has a impact on product quality termed as Major. Non Critical process parameters, momentary variations in environmental condition, weighment of excipients, calibration of non critical instruments, cleaning of components not coming in direct contact with product, batch coding, secondary packing etc.
- Minor: The deviation, which has no direct impact on product quality. Such as cleaning of non core areas, entry in documents/ log books, cutting, over writing, issues related to tertiary packing, shortages and typographical errors.
- QA Head/ designee shall evaluate the deviation and shall provide his recommendations as
- The department head along with representative from QA will determine whether these deviations
are having any impact on the quality of the product.
- Concerned department head shall recommend the corrective and preventive actions to prevent
reoccurrences of the same.
- Then the deviation form shall be submitted to the QA department. QA In-charge shall in turn to
verify the extent of impact and suitability of corrective and preventive actions.
- QA Head shall evaluate the deviation report along with the opinion of the other
Department Heads for the impact of deviation.
- On complete evaluation of the content of the deviation, QA Head shall either approve or
reject the deviation.
- It shall be the responsibility of QA to verify the compliance of corrective and preventive actions.
- The impact of the deviation shall be evaluated on the other batches manufactured in the
same campaign/ equipment/ area or using same raw materials/ packing materials depending upon
the investigation findings.
- In case of Deviation related to incoming raw material / packing materials, the
investigation may be extended to the vendor’s site in order to find out the cause for the Deviation
This may be done through discussions with the vendor, process reviews,
transportation methods or site audits. Accordingly CAPA shall be instituted at vendors end.
- A trend of Deviations, observations shall be maintained and this historical data shall
be reviewed to identify the reoccurring instances and for drawing correlation and impact
assessment. Such trends shall also be utilized to track the effectiveness of corrective and
preventive actions taken time to time.
- All the investigations shall be completed within 30 days from the date of observation of the
- The deviation log register shall be maintained in QA.
- The deviation shall be closed out after implementation of CAPA. It shall be the responsibility of QA to verify the completion of corrective and preventive actions. Then the deviation sent to the Head QA for final close out.
- Trending of Deviation:
- Continuous trending of the deviation shall be carried out. QA shall carry out the trend analysis for all the whole year deviation, at the beginning of the next year.
- A copy of trend analysis shall be forwarded to Head Quality.
- The trending shall be carried out for the deviation to categorized as Critical, minor & major deviation.
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
|Sr. No.||Annexure No.||Title||Format No.|
|SOP||Standard Operating Procedure|
- REVISION HISTORY OF CHANGE
|Sr. No.||Date||Revision Details||Revision No.|