SOP for Handling of Planned Deviations and Incidents
1.0 OBJECTIVE:
The objective of this procedure is to understand, identify and investigate incidents (unplanned deviations) and planned deviations in any Department.
2.0 SCOPE:
The scope of this Standard Operating Procedure (SOP) is to provide the handling procedure of unplanned deviations/ incidents observed and planned deviations proposal in any department.
Note: Planned deviation also called as temporary change.
3.0 RESPONSIBILITY:
3.1 Concerned personnel or operating department shall raise the unplanned deviations/ incidents observed and planned deviations.
3.2 Concerned Department Head shall review, investigate and plan for corrective and Preventive actions.
3.3 Head-Quality Assurance/ designee or the concerned personnel to review/ dispose the unplanned deviations/ incidents observed and planned deviations.
3.4 Head QA to ensure the compliance.
4.0 PROCEDURE:
4.1 Incident:
4.1.1 Definition: An incident/ deviation is unplanned event that occurs in non-compliance with the designed systems or procedures at any stage of the receipt, storage and manufacture and analysis of a drug product.
4.1.2 Incidents are classified as
4.1.2.1 Quality Impacting (Major)
4.1.2.2 Quality Non-impacting (Minor)
4.1.3 Quality Impacting Incidents: Quality Impacting Incidents are occurrences / errors during execution of an activity which will affect the Quality, Safety, Identity, Stability, Efficacy, Purity and Strength of a drug product.
4.1.4 Quality Non-Impacting Incidents: Quality Non-Impacting Incidents are occurrences during execution of an activity which may have no impact directly or indirectly on the Quality, Safety, Identity, Stability, Efficacy, Purity and Strength of a drug product.
4.1.5 Various examples of Quality impacting and Quality non-impacting incidents are listed in Annexure-I.
4.1.6 Addressing of incidents:
4.1.6.1 Incidents shall be addressed through incident report (Annexure-II).
4.1.6.2 When an incident is observed, concern person shall inform to his/ her Head of the Department or his designee.
4.1.6.3 Concerned person shall raise an incident report with a brief description of the incident with all details of Product/Material and forward to Head of the department or his designee.
4.1.6.4 Concern Department Head or his designee shall classify the incident and forward the same to QA department for numbering of incidents.
4.1.6.5 Numbering of Incidents:
4.1.6.5.1 All incidents shall be identified with unique identification number.
4.1.6.5.2 Incident number shall as follows.
4.1.6.5.3 First three character denotes department code (Refer annexure-III for department codes).
4.1.6.5.4 Fourth character “D” indicates Incident.
4.1.6.5.5 The next three characters are serial numbers starting from 001 for the every year starting from January.
4.1.6.5.6 Eighth character is”/” (slash).
4.1.6.5.7 Last two characters indicates the year
4.1.7 QA person shall provide the incident number along with annual reoccurrence history for repeating of the same incident. Eg. It shall be mentioned as 1st time, 2nd time and so on. The details of incident shall be recorded in register for numbering of Incidents (Annexure-IV) and shall be forwarded to the initiator.
4.1.8 Concern department head or his designee shall investigate the incident. Laboratory incidents shall be investigate as per Annexure VI, if required other department help shall be taken for further investigation.
4.1.9 After investigation, concern department personnel shall record the details in incident report. If required separate page shall be attached as an annexure to incident report for corrective and preventive actions (if any) with TDC (Tentative date of completion) and shall be forwarded to QA department for QA comments and copy of the same shall be given to concerned department for reference. After implementation of corrective action and preventive action, concern department person shall send backup data (if any) to QA person for review and final Disposition. Head QA/ designee or concerned personnel shall fill the details of the same in the CAPA register.
4.1.10 After the Quality Assurance review, if it is found satisfactory, concerned QA personnel shall dispose the incident after verifying the CAPA.
4.1.11 If Quality Assurance feels further investigation needs to be done, the same shall be instructed.
4.1.12 After completion of corrective and preventive actions, with a sufficient back-up data reviewed from concern department concerned QA personnel shall dispose the incident.
4.1.13 Original Copy of the incident report shall be kept in QA office, photocopy shall be issued to concern department to be kept in corresponding record of analysis/BMR/BPR etc. as per requirement,
4.1.14 Wherever required reference of the incident number shall be mentioned in corresponding raw data.
4.1.15 All the incidents shall be disposed within the days as specified in CAPA, if not shall be justified by Head of the concerned department. If necessary supporting documents shall be provided with the incident report.
4.1.16 In case of Quality Control incidents related to analysis of drug products, drug substances, container and closures etc.,, Checklist for investigations of laboratory incidents (annexure-VI) shall be followed. The investigation details are not limited to details on the checklist.
4.2 Planned Deviation:
Definition: A planned deviation is an activity performed differently and/or modified than specified in an approved document. The proposed action shall be planned and approved before execution by the concerned department.
4.2.1 Addressing a planned deviation:
4.2.1.1 All the planned deviations shall be addressed through Planned Deviation report (Annexure-VII).
4.2.1.2 The planned deviation report shall be prepared by the concerned person and shall be authorized by concern department Head or his designee. Head of department shall fill the action taken/ to be taken to avoid reoccurrence of planned deviation along with tentative date of completion (TDC), and forward the same to Quality Assurance for numbering and approval.
4.2.1.3 The numbering system is similar to incident numbering system (follow points mentioned under 4.1.6.5) except that “PD” indicates Deviation instead of “D” which indicates incident.
4.2.1.4 Concern Quality Assurance person shall provide a planned deviation report number along with annual reoccurrence history for repeating of the same deviation. Eg. It shall be mentioned as 1st time, 2nd time and so on and details shall be entered in “Register for numbering of Planned Deviations” (Annexure-VIII).
4.2.1.5 Concern Quality Assurance personnel/ Head -QA or his designee shall review the deviation following the impact assessment done with the change in document suggested (if any) and if found justified, shall be approved or else reject the same. And proceed ahead in the matter accordingly. Photocopy of planned deviation to be given to concerned department.
4.2.1.6 Wherever required reference of the planned deviation report number shall be mentioned in corresponding record.
4.2.1.7 The planned deviation shall be closed with the compliance status of the action taken with the days specified. Follow-up actions (if any) shall be completed within Date specified in Target Completion Date (TCD) of CAPA, if not shall be justified.
4.3 Trending of incidents and planned deviations shall be done once in 3 months, department wise by Quality Assurance personnel.
4.4 Recurrence of Incidents/ planned deviations (if any) shall be viewed critically, further actions if required shall be taken.
4.5 Original Copy of the Planned Deviation report shall be kept in QA office, photocopy shall be issued to concerned department to be kept in corresponding record of analysis/ BMR/ BPR etc. (on requirement basis).
5.0 ANNEXURE:
Annexure – I: Examples of Quality impacting incidents
Annexure – II: Specimen format of “Incident report”
Annexure – III: List of Department codes
Annexure – IV: Specimen format of “Register for numbering of incidents/Planned deviation”
Annexure – V: Flow chart for flow of incidents / Planned deviation
Annexure – VI: Checklist for investigation of laboratory incidents
Annexure – VII: Specimen format of “Planned deviation report”
Annexure – VIII: Specimen format of “Register for numbering of Planned deviations”
Annexure – I: Examples of Quality Impacting Incidents
Note: The below given examples are directive but not limited.Case to case evalution shall be done.
Dept.: Quality Control
1 Calibration failure .
2 Missing of samples for analysis.
3 Any additional and/or unexpected peaks observed during chromatographic analysis.
4 Instrument Stop While Performing Analysis
5 Calibration not performed on Due period
Dept. : Production
1 Appropriate written procedures not followed.
2 Deviations to the % yield limit specified in product BMR/BPR.
3 Holding period of drug product/in-process material exceeds the specified time interval.
4 Entries of parameters / equipment clearance / cleaning / usage not made in BMR/BPR /
log books.
5 Particle count and microbial load in area out of limit.
6 Damage of the screen of comminuting mill during operation.
7 Failure of equipment during processing of product.
8 Assigning of incorrect manufacturing/expiry dates to the drug product.
9 Calibration failure during calibration of instruments/equipment.
10 Failure of power or breakdown of equipment during critical process of batch.
11 Spillage Of material
Dept.: Quality Assurance
1. Temperature & RH for stability chambers are not within specified limits for specified time.
2. Product released without review of batch records.
3. Stability and reserve samples are not collected during packing.
4. Stability samples not withdrawn as per the schedule.
5. Missing to load stability samples.
6. Incorrect assigning of batch numbers.
7. Incorrect issue of documents.
Dept. : Warehouse
1. Assay values calculations done wrongly during dispensing of raw materials.
2. Wrong dispensing of material.
3. Calibration failure during calibration of instruments/equipment.
Dept. : Engineering
1 Calibration failure during calibration of instruments/equipment.
2 Damage of machines/instruments during maintenance work.
3 Inconsistent quality of utility.
4 Usage of critical /major instruments after replacement of parts without validation/calibration.
5 Missing of PMP (Preventive maintenance plan)
Examples of Quality Non-impacting Incidents
Dept. : Quality Control
1. Missed/errors in entries during documentation which don’t affect the end result.
2. Performing PPM beyond schedule or missing of PPM (Planned Preventive Maintenance)
3. Failure to calibrate the non-critical instruments (which does not have any impact
on Quality) as per schedule.
4 Failure of bracketing standards.
Dept. : Production
1. Entries missing in logbooks
2 Failure to calibrate the non-critical instruments (which does not have any
impact on Quality) as per schedule.
Dept. : Engineering
1. PMP performed beyond schedule or PMP missed as per the schedule.
2. Failure to calibration of noncritical instruments.
3. Missing of breakdown entries in log books.
Dept. : Warehouse
1. Calculation errors which are not effecting the final values.
2. FIFO (First in first out)system not followed
Annexure – II: Specimen format of “Incident report”
Dept:
Reoccurrence History
Title:
Incident No:
Batch No. /Lot No.
Reference No.
Detected on
Detected by/Date
(If applicable)
(If applicable)
Brief description of the Incident (Section -I):
HOD(Sign.):
Date:
Date:
Evaluation/Conclusions (Section -II): Classified as:
HOD (Sign./Date)
Corrective Action (Section -III): TDC:
HOD (Sign/ Date)
Preventive action to avoid reoccurrence (if any) (Section IV):
TDC:
HOD (Sign/ Date)
Comments of QA
Head – QA (Sign/ Date):
Disposition (Section V):
QA Personnel (Sign/ Date):
Head – QA (Sign/ Date)
Annexure – III: List of department codes
Quality Assurance – QAD
Quality Control – QCD
Production – PRD
Engineering – END
Warehouse – WHR
HR and Administration – HRD
Annexure-IV: Register for numbering of incidents
Product/Material
Batch No./ Ref. No. (if applicable)
AR No.
Incident No.
Detected on
Nature of Incident
Due date
Brief summary of disposition (if applicable)
Annexure – V: Flow chart for flow of incidents / Planned deviation
[Not provided here]
ANNEXURE – VI: CHECKLIST FOR INVESTIGATION OF LABORATORY INCIDENTS
Write Observation as Yes/No
1. Were the equipment/Instrument used for analysis in calibrated state ?
2. Did all components/parts of equipment/ instrument function properly.
3. Was there evidence that the equipment is contaminated ?
4. Was the SOP adequate and operation performed as per SOP?
5. Were the glassware used calibrated ?
6. Were the glassware used properly washed ?
7. Was there evidence that the glassware used may be contaminated ?
8. Were the instrument problems such as noisy baseline, poor peak resolution, poor injection reproducibility, unidentified peaks or contamination that affected peak integration, etc., noticed ?
9. Any critical parts of equipment/instrument like detector, lamp etc., needed replacement?
10. Was the correct test procedure followed ?
11. Was the test procedure adequate and followed properly ?
12. Were the standards, reagents used properly stored ?
13. Were standards, reagents properly labeled ?
14. Was there evidence that the standards, reagents have degraded ?
15. Were the reagents/chemicals used of recommended grade ?
16. Was there evidence that the reagents, standards or other materials used for test were contaminated ?
17. Were standards, reagents used within their expiration dates ?
18. Were volumetric solutions standardized as per procedure ?
19. Were Working standards standardized as per testing procedure ?
20. Were the dilutions made in sample/standard preparation as per testing procedure ?
21. Was the Analyst trained in the particular test ?
22. He/she understood test procedure.
23. He/she calculated the results correctly as mentioned in test procedure
24. Was there any similar occurrence with the analyst earlier ?
25. Was there any similar history with the product/ material ?
26. Were the environmental conditions (temperature, humidity, light) appropriate ?
27. Any other reason, specify Analyst
(Sign.) :
Date :
Head -Quality Control (Sign.) :
Date :
Annexure-VII: Planned deviation report
Date:
Reoccurrence History
Planned deviation No.
Ref. No. (If Applicable)
Department
Title:
Proposed Planned Deviation:
Period :
Sign/Date:
Reasons for Planned Deviation:
Sign/Date:
Justification for Planned Deviation:
Authorised By: HOD (Sign/Date)
Action taken to avoid reoccurrence of planned deviation:
TDC:
HOD (Sign./Date)
Planned deviation Approved / Rejected:
1. Impact Assessment/ Remarks:
2. Change in documents Suggested (if any)
Head – QA (Sign.):
Date:
Closure of Planned Deviation:
Compliance status of action taken:
All action mentioned above is executed to the desire requirements and found satisfactory. Hence planned deviation is Closed
QA Personnel (Sign/Date)
Head QA (Sign/Date)
Annexure-VIII: Register for numbering of planned deviations
S No.
Date
Planned deviation No.
Brief description of the planned deviation
Allotted by/ Date