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CHANGE HISTORY
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1. OBJECTIVE:
1.1. This SOP laydown procedure to ensure the deviation is identified , investigated ,reported and
appropriate corrective nd preventive action has been taken to:
 Safeguard the quality attribute of the affected product or material.
 Ensure effective corrective and preventive action are taken.
 Prevent reocurrence of deviation.
2. SCOPE:
2.1. This SOP is applicable for
 Any deviation in the facility, product, manufacturing, analysis, documents in Alesraa
pharmaceutical optima.
 All types of deviations: planned or unplanned deviations.
 Reporting, evaluating, implementing corrective and preventive measures and proper closure of
the deviations.
3. RESPONSIBILITY:
3.1. Deviation initiator:
 Promptly report the deviation to quality assurance department.
 Provide accurate and detailed information about the deviation.
3.2. Quality Assurance head responsible or his designee for: -
 Receiving and log in the deviation in deviation logbook.
 Assign unique deviation identification number for tracking process.
 Collect the adequate information required for deviation investigation.
 Forward deviation to concerned department for investigation.
 Review investigation report from concerned department.
 Assess and classify deviation according to potential impact on product quality, safety and
efficacy.
 Prepare and initiate corrective and preventive action plan for quality related deviation.
 Conduct periodic reviews to identify trend or recurring issues in deviations and propose process
improvements.
3.3. Subject matter expert Shall be responsible for: -
 Investigate the deviation.
 Prepare the investigation report.

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 Taking immediate action.
 Suggest corrective and preventive action.
3.4. Quality control department responsible for: -
 Corporate with QA in the process of investigation
 Monitor the analysis of deviation sample as per approved action plan.
 Provide analytical result or any other data with conclusion.
3.5. All department in Alesraa pharmaceutical has responsibility to: -
 Corporate with QA in investigation process.
4. DEFINATION:
4.1. Deviation: departure from process, procedure or unexpected result and its classified as given
below:
4.1.1. Unplanned Deviation: Any deviation occurred in unplanned or uncontrolled manner due to
system failure or equipment break down or manual error and can be arise out of :
 Human error.
 Malfunctioning of equipment or instrument.
 Equipment or instrument breakdown.
 Utility or service failure / breakdown.
 Others as determined.
4.1.2. Planned Deviation (Change Control):

Any deviation from documented procedure required for a temporary period to manage
unavoidable situation without affecting the quality and safety of intermediates / APIs and can
be arise out of :

 Quality improvements.
 Yield improvements.
 Safety reasons.
 Better GMP.
 Market requirements.
5. PROCEDURES:
4.1.Source of deviation
 Staff observations.
 Service requests.

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 Internal complaints.
 Self-inspections, third party audits, official inspections.
 Product quality reviews.
 Process monitoring (Batch Record).
 Environmental monitoring.
 Out of specification (OOS).
4.2.Deviation identification and reporting
 Deviation initiator shall report deviation with clear picture of what happened to department
manager or his designee.
 Initiator shall fill the details like: Deviation date, Reporting time, product or material name,
Batch or lot No., and deviation description.
 The department manager or his designee shall review deviation.
 Write a note on the place of deviation in batch manufacturing record with date and signature of
the responsible person.
 As per severity of deviation and stage of process the process may be stopped for initial
assessment.
 The department manager or his designee with concerned department and QA designated person
assess and take suitable immediate action, provide all details for aiding in investigation and send
deviation report to Quality assurance head.
 Based on assessment by initiating department, concerned department and QA department any
component(s)/bulk products/finished product which have been affected by failure shall be
quarantined and stored as per respective product stoppage condition till investigation is
completed and the decision regarding disposal is made.
 QA must log the deviation within one (01) working day.
 QA Assign unique deviation identification number for tracking process as the following: -
 SSS/MM/YYYY
 SSS: three-digit for serial number (i.e. 001,002, 003,)
 MM: two-digit for month (i.e. 01 for "Jan", 02 for "Feb")
 YYYY: four-digit for year (i.e. "2024")
 QA Forword deviation for concerned department.
 Note:Planned deviation shall have prior approval from the quality assurance manager.
4.3. Categorization of Deviation
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  QA must categorize the deviation initially as critical, major, or minor based on the nature of the
deviation.
Critical Deviation: Major Deviation: Minor Deviation:
 Its deviation affect a quality attribute, a  Its deviation affects a quality  its deviation does not affect
critical process parameter, an equipment attribute, a critical process any quality attribute, a critical
or instrument critical for process or parameter, an equipment or process parameter, or an
control, of which the impact to patients instrument critical for process equipment or instrument
(or personnel/environment) is highly or control, of which the impact critical for process or control.
probable. Including life threatening to patients (or personnel
situation. /environment) is unlikely.
 Requiring immediate action, corrective  Requiring immediate action,  Not requirre immediate action,
action, investigation, and root cause and corrective action, investigation, corrective action, investigation,
documented and root cause and documented. and root cause and
documented.
 Usage of contaminated raw materials and  Machine breakdown during  Minor errors in batch records
solvents. processing. or documents that do not affect
 Failure to process step during the the integrity of the data.
manufacturing.  It may arise as a consequence of  Spillage of material during
 Use of obsolete batch document/test numerous repeated minor dispensing.
method. deviation
 It may arise as a consequence of
numerous repeated major deviation
4.4. Investigation:
 When the deviation is major or critical, root-cause analyses are required. This means that the
deviation will have a significant impact on your product's or cGMP's overall quality. If the
deviation is labeled as an incident or minor, no investigation and root-cause analysis is
required.
 Investigation shall be carried out by the initiating department and when required, a cross-
function team shall be identified by the concerned and QA department.
4.4.1. The investigation shall include steps defined below:
4.4.1.1. Defining the non-conformity: The non-conformance observed shall be fully
documented.
 The product under investigation
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  Quality system problem under investigation
 Process problem
 The event description leading to the investigation.
 The area affected.
4.4.1.2. Data collection: All the relevant data related to the non-conformance shall be collected
and documented. The data collection shall include review of various documents relevant to
the non-conformity, which may include, but shall not be limited to, the following;
 Review of similar incidences/failures in last two (2) years.
 History of the product.
 Batch production and control records.
 Equipment logbooks.
 Material usage and inventory records.
 Test data.
 Maintenance records.
 Cleaning records.
 Training records.
 Relevant environmental monitoring records as applicable.
 Records of various utilities used.
 Stability data.
 Product development reports.
 Validation/Qualification reports.
 Equipment/Instrument calibration records.
 Standard operating procedures.
 Annual product reviews.
 Interview/s with operating personnel.
4.4.1.3. During the investigation all above documents are reviewed by the investigation team.
If required relevant persons of the investigation team may visit the site/place to understand
the situation and also review/evaluate the relevant procedure/practices followed.
4.5. Root cause analysis
 Root cause shall be established based on the observations during investigation and analysis of
available data using tools like, 5 Whys, chronology analysis, barrier analysis and fishbone
diagram, etc.
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 If the root cause is not established based on the available data, then experiments may be planned,
or review of unit operation may be carried out to collect additional data to confirm the root
cause. Before carrying out the experiment, the objective and the experimental plan shall be
clearly defined and documented in the experiment protocol which shall be reviewed and
approved by QA. The results of the experimental study shall be documented, evaluated and
approved by QA in order to draw conclusions.
 If the investigation report indicates human error as the cause for the non-conformance, then
further evaluation shall be done with respect to following aspects:
 Clarity of instructions in procedures.
 Adequacy of training.
 Adequacy of supervision.
 Experience of the person.
 Past history of such incidences in last two (2) years.
 Fatigue.
 Any circumstantial trigger, e.g., receiving more than usual work assignments on that
day.
 The psychological state of the person on that day.
 Adequacy of the infrastructural support for job delivery, e.g., in hardware
 design, whether there is any inherent problem with the machine that is responsible for
the non-conformity.
4.6. Assessment and Resolution:
4.6.1. Risk assessment
 Risk assessment initiated if needed based on the recommendation from investigation team.
 Risk assessment can be carried out taking into account system failure during investigation. It
could be performed as per Quality risk management procedureQAP-09-078.
 Risk Assessment for deviation can be based on severity and occurrence.
 The evaluation of risk to the quality of the drug product/substance can be assessed based on
scientific knowledge and ultimately linking it to the patient’s safety.
 Immediate actions may be taken to rectify the problem wherever applicable.
4.6.2. Corrective and preventive action plan
 Appropriate corrective and preventive actions can be initiated based on the findings of the
investigation and according to QAP-14-015.

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 QA must implement the corrective and preventive action and monitor its effectiveness.
 If any change in the documents / process /system as suggest in the corrective and preventive
action that will be change through the change control procedure QAP-16-013

4.7. Closure of deviation

 QA shall close the deviation. The deviation must be completed within thirty (30) working days
of detection of the non-conformance. However, investigations which may require more than
thirty days for completion can be extended based on rationale/justification duly approved by QA
and as per procedure defined in respective SOPs.
 The investigations, in such cases, shall be completed as per the new timeline decided.
 An interim investigation report with status as on date shall be submitted in such cases.
 QA shall review the logbook on monthly basis to identify the deviation which need to be closed.
 Quality assurance manager and quality control manager shall decide to release or not the
involved product / batches and that is reported in deviation closure section.
 After approval of the deviation by quality assurance manager, file the original copy of the
deviation at the quality assurance and photocopy send to concerned department.
 Quality assurance shall maintain the deviation log which should include – Deviation report
number, Product / Batch number (if any), type and nature of deviation, Corrective action taken
and date of closure of deviation.
4.8. Trend analysis
 QA will initiate trend analysis based on number of deviations per year and root caue for
deviations.
 In cases of human error, training, environmental monitoring excursions, cleaning deviations,
testing errors, etc., trend analysis can help you determine if the corrective action has remediated
the issue.
 Review data over a predetermined timeframe and determine if the problem or deviation has
occurred again (or as frequently) after the corrective action was implemented.
 In most cases, the data will tell you if the fix was successful, or if another corrective action
should be established.
 Trend analysis of all deviations shall be performed annually.
 Trend analysis can be completed within one month of completion of year.
 Tool used: Histogram or run chart

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6. REFERANCE
 WHO TRS 986 ANNEX2,2014
7. ATTACHMENTS:
4.9. Deviation reporting form.
4.10. Deviation investigation and approval form.
4.11. Deviation Progress logbook.
4.12. Deviation trend analysis form

7.1. Deviation Reporting Form

Ser. No.:
-….…/..…/…….

Initiator:……………………………………………………..... Position:…………………….

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 Reporting Date:…………………………………………………. Reporting Time:…………………..
Deviation detected by:………………………………………….. Position:……………………………..
During:…………………………………………………………………………. Deviation categorize by QA
Subject:…………………………………………………………………………..
……………………………………………………………………… □ Minor □ Major □ Critical
Product/Material name:…………………………………………… Supplier name:………………..
Control number:……………….. Batch / lot number:……….. Mfg./Exp.:……………………......
Deviation
description:---------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------------------------
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Deviation
causes:------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------
Responsible Person: ---------------------------------------- Department Manager: -------------------------------------
Immediate corrective action(s):
----------------------------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------------------------

---------------------------------------------------------------------------------------------------- Immediate Corrective action

by:---------------------------------
Suggested corrective action(s):
----------------------------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------- Suggested Corrective action

by:------------------------------
Corrective Action Needs Change
Control:----------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------
DOC#
7.2. Deviation Investigation and Approval Form
Subject: Receiving time:

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 Receiving Date: Originating Department:
Defining of non-conformity ……………………………………………………
Investigation team
Name Title
…………………………………………………… ……………………………………………………
Investigation
Step Finding
Review of similar incidences/failures in last two ……………………………………………………
(2) years.
History of the product. ……………………………………………………
Batch production and control records. ……………………………………………………
Equipment logbooks. ……………………………………………………
Material usage and inventory records. ……………………………………………………
Test data. ……………………………………………………
Maintenance records. ……………………………………………………
Cleaning records. ……………………………………………………
Training records. ……………………………………………………
Relevant environmental monitoring records as ……………………………………………………
applicable.
Records of various utilities used. ……………………………………………………
Stability data. ……………………………………………………
Product development reports. ……………………………………………………
Validation/Qualification reports. ……………………………………………………
Equipment/Instrument calibration records. ……………………………………………………
Standard operating procedures. ……………………………………………………
Annual product reviews. ……………………………………………………
Interview/s with operating personnel. ……………………………………………………
Others: …………………………………………
Root cause
…………………………………………………………………………………………………………
Risk assessment is required Yes No
Corrective and preventive action is required Yes No
Deviation need to change control Yes No
Approvals:

Department (Manager) Acceptance of proposed action(s) Signature Date

Material  Yes  No
Production  Yes  No
Quality Control  Yes  No
Regulatory Affaire  Yes  No

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 R&D  Yes  No
Safety  Yes  No
Maintenance  Yes  No
IT  Yes  No
Finance  Yes  No
Warehouse & Logistic  Yes  No
Quality Assurance  Yes  No
Technical Director  Yes  No
Proposed Action Initiated by: --------------------------------------------------Sign/Date : -----------------------
Corrective Action implemented by: -------------------------------------------Sign/Date: ------------------------
Preventive Action implemented by: -------------------------------------------Sign/Date: ------------------------
Closure remarks:
-------------------------------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------

Results / Impacts of deviation: Satisfactory / Not satisfactory

The deviation is Approved / Not Approved

QA Manager sign.: --------------------------------

DOC#

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 7.3. Deviation Progress logbook. Quality Assurance Department

Distribution
Immediate Suggested Corrective action Preventive Action
of Deviation

Sign by
Corrective Corrective Deviation categories
Ser. # Department QA Receiving Date Deviation Subject Action Action Action Action
Taken Person Date Taken Person Date Yes No
Y N Y N Critical Major Minor Y N Y N

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7.4. Deviation Trend analysis form

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 Number of deviations per year basis

Year Deviation/year Chart

 Root cause basis

Year Root cause Deviation/year Chart

 Classification basis

Year Classification Deviation/year Chart

 Conclusion:

DOC#

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