Galaxy Chemicals (Egypt) S.A.

Deviation and Incident Document No. APEX/GCE/GMP/MOGP – 6.5

control procedure Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 1 of 7
Operating Process : Manual of General Procedures

Title: Deviation and Incident control procedure

1. Purpose: This SOP describes procedure for deviation control and incidents reporting, review and
management
2. Scope: This SOP is applicable for deviations occurring at all locations at Galaxy Surfactants Limited
3. Responsibility:
3.1. It is responsibility of individuals at all departments to report deviations as they happen.
3.2. It is responsibility of section in-charge or process leader to investigate cause of deviation,
provide corrective action and preventive action and review it.
3.3. It is responsibility of QA personnel to log deviations, review CAPA provided. QA personnel is
also responsible for review of CAPA effectiveness for implemented CAPAs for all sites.
3.4. It is responsibility of Head Quality or designated deputy to approve deviation and CAPA.

4. Procedure:
4.1. Deviations are departure from the listed procedure.
4.2. Incidents are defined as irrelevant event not impacting product quality.
4.3. For any event happened, following two questions should be asked.
 Can the event affect a product quality attribute, manufacturing operational parameter or
product quality?
 Does the event contradict or omit a requirement or instruction contemplated in any kind of
approved written procedure or specification?

4.4. If the answer to above two questions is no then the event is classified as Incident. And if one of
the answer to above questions is yes then the event is classified as Deviation.
Deviations:-

4.5. Deviations can be defined in following examples:

a) Failure to follow manufacturing steps mentioned in the Batch manufacturing process.
b) Failure to calibrate instrument in given time frame.
c) Use of un-calibrated instruments.
d) Deviation to follow documented analytical process.
e) Deviation in following GMP practices in laboratory.

4.6. Following paragraph describes definitions and methodology of the deviation control system.
Deviation is defined as departure from standard practices which may results in non-conforming
product or process with potential impact on the quality, safety, usability of data integrity.

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Deviation and Incident Document No. APEX/GCE/GMP/MOGP – 6.5

control procedure Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 2 of 7
Operating Process : Manual of General Procedures

Following steps may be used in handling events and possible deviations:

1. Event detection
2. Decision making process/ Deviation categorization
3. Deviation treatment
4. Root cause investigation
5. CAPA
1. Event detection:
It is necessary the deviation is detected first. For this personnel are expected to be alert and
aware of possible undesirable events and clearly what to do in terms of documentation and
communicating them.
Personnel can use decision tree to identify the risk and effect of the deviation on the final quality
of the product in order to categorize, record and investigate them.
Deviations are recorded as they happen, and number is generated in QA. Further identification
of the deviation is kept by the basis of this number.
2. Deviation categorization:
Deviation are categorized as follows: Majorly deviations are classified as planned deviations and
unplanned deviations.
Example of planned deviations could be change in the calibration date for a particular equipment
Example of unplanned deviations could be variation in the temperature recording during the
reaction.
Also deviations can be classified as minor, major and critical based on the criticality of the impact
on the process.
3. Minor deviations:
When the deviation does not affect any quality attribute, a critical process parameter, or an
equipment or instrument critical for process or control, it would be categorized as Minor, and
treated as such by the applicable procedure. Possible examples of minor deviations are as
follows:
 Minor deviation in the temperature of the reaction used only for monitoring purpose.
 Skip of FEFO principle (first expired-first out) in raw material handling.
 Weight balance out of tolerance used to determine gross weight of raw materials upon
reception.

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Deviation and Incident Document No. APEX/GCE/GMP/MOGP – 6.5

control procedure Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 3 of 7
Operating Process : Manual of General Procedures

4. Major deviations:
When the deviation affects a quality attribute, a critical process parameter, an equipment or
instrument critical for process or control, of which the impact to consumer is unlikely, the
deviation is categorized as Major requiring immediate action, investigation, and documented as
such by the appropriate SOP. Possible examples of major deviations are given below:
- Use of unapproved reference standard to test a substance.

- Inadequately trained personnel to perform sterility tests.

- Production started without line clearance.

- Pressure differential out of established limits in aseptic fill areas.

- Operational parameter out of range for a parameter defined as non-critical.

5. Critical Deviation:
When the deviation affects a quality attribute, a critical process parameter, an equipment or
instrument critical for process or control, of which the impact to customer is highly probable, the
deviation is categorized as critical requiring immediate action, investigated, and documented as
such by the appropriate SOP.
Possible examples of critical deviations are given below:
- Sterilization record of product-contact material used in aseptic filling process not available or
unacceptable.

- Incomplete inactivation stage of fermentation.

QA department will determine the level of criticality of the deviation and will assign it in the
deviation control form.

6. Handling Deviations:
Based on the categorization of the deviation, individual action should be decided.

Minor deviations:
Minor deviations are normally addressed by corrections which are taken to correct and address
the problem. This should be supported by sufficient documentary evidence.
Corrections are immediate actions taken based on existing experience. The process should be
QA approved possibly, if not then it should be monitored by a qualified person. QA should
approve should corrections as soon as possible. Minor deviations need not have investigation to
identify the root cause of the problem.
After correction, outcome is verified based on the immediate outcome of the actions.

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Deviation and Incident Document No. APEX/GCE/GMP/MOGP – 6.5

control procedure Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 4 of 7
Operating Process : Manual of General Procedures

Major or critical deviations:

Major or critical deviation should have through description. Correct the deviation first with QA
approved procedure or methodology or direction.
Perform through investigation of the root cause of the deviation and document it in the form.
After determining root cause of the deviation, derive a corrective action.

If the minor deviation is repeated a significant number of times, it should be termed as major
deviation and investigation of deviation should be determined to investigate failure of corrective
actions implemented earlier.
QA department should access the CAPA plan forwarded individual departments for its feasibility.
Results should be verified against the CAPA action. In case the CAPA action is insufficient then
new requirements should be generated by QA departments.
Root cause investigation (analysis):
The impact on the affected process, equipment, system or product should be assessed
regarding other similar situations that could be taking place or will occur. A “vertical” analysis to
identify the root cause should always be accompanied by a “horizontal” analysis on the possible
events that could be avoided in the future by extending the scope of the investigation to evaluate
the possible impact of the deviation on other lots of the same product or on other similar
manufacturing processes.

In case firm conclusion is not obtained then decisions taken should always be rationale,
supported and well documented.
Deviation is provided with sufficient evidences of the root cause investigation.
Corrective action and Preventive action:
Based on the root cause investigation, define corrective action plan for deviation. Along with this
also specify the preventive action plan to avoid reoccurrence of the deviation.
Every corrective action may or may not have preventive action plan.
Corrective actions should be QA approved in the documents.
Corrective actions for a deviations can be horizontally applied across sites, processes to
eliminate further deviations.

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Deviation and Incident Document No. APEX/GCE/GMP/MOGP – 6.5

control procedure Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 5 of 7
Operating Process : Manual of General Procedures

Reporting of deviation
(Planned or unplanned)

Propose immediate action with justification

Logging and issuance of Deviation Approval Form

Filling in details of deviation

Review of deviation details

Whenever require d

Requirement of Recall Investigation and impact assessment

Root cause analysis Major or Critical Minor

Propose CAPA

Disapproved

Deviation Closed or Review and approval of deviation.

cancelled Acceptance of immediate action and CAPA

Implementation of immediate action

Deviation closing with review of supporting data

Implementation of CAPA

Review and trending of Deviation

Documentation

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Deviation and Incident Document No. APEX/GCE/GMP/MOGP – 6.5

control procedure Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 6 of 7
Operating Process : Manual of General Procedures

4.7. Mention details such as date, exact deviation activity, root cause of deviation, Quality impact
assessment, Corrective action and Preventive action on final product in the Annexure: I.
4.8. QA should assign a unique number to the Deviation form. Deviation form should be numbered
as DEV/M/YY-ZZ/XXX
Where YY = initial financial year
M = Site code such as Tal, Tar, Jha, GCE
ZZ = Final financial year
XXX = serial number

4.9. Record deviations in log book as mentioned in Annexure-II

4.10. After completion of the investigation and CAPA action, deviation form along with documentary
evidence should be submitted to QA.
4.11. QA shall review the completeness of the deviation form and correctness of the CAPA action
take. QA shall also review all documentary evidences attached to the deviation.
4.12. In case the evidence is not as per the requirement, QA department shall ask for additional
evidences.
4.13. QA Head or designated deputy approves or dis-approves deviation report.
4.14. It is the responsibility of the concerned department to monitor the CAPA actions later on.

Incidents:

4.15. In case of Incidents, it is the responsibility of concerned departments to raise the Incident
report.
4.16. All Incidents shall be recorded
4.17. Mention details such as date, exact Incident activity, and probable cause.
4.18. In case of incidents, probable cause of the incident shall be reported.
4.19. Corrective action if required should be mentioned in the incident report.
4.20. No investigation need to be performed and reported.
4.21. QA assigns a unique number to the incident as INCT/M/YY-ZZ/XXX
Where YY = initial financial year
M = Site code such as Tal, Tar, Jha, GCE
ZZ = Final financial year
XXX = serial number

4.22. Maintain incidents log in book as mentioned in Annexure-IV.

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Deviation and Incident Document No. APEX/GCE/GMP/MOGP – 6.5

control procedure Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 7 of 7
Operating Process : Manual of General Procedures

4.23. If the incident is repeated multiple times, it should be converted to deviation and through
investigation should be performed.
4.24. Incidents shall be approved by QA designate.
4.25. In some cases, department owner is authorized to sign and conclude on the basis of low
criticality
of the incidents. QA should be informed about it. QA should monitor such incidents
periodically.

4.26. All deviations physical copies shall be retained by quality assurance department.
4.27. Corrective action and preventive actions taken for deviations shall be tracked in a suitable way
by concerned departments and should be verified by quality assurance department.
4.28. Annually trending for all deviations shall be performed by sorting them based on cause or
process or department. Conclusion shall be drawn from trending and further course of action
shall be decided to reduce deviations.

5. Definitions and Abbreviations:

5.1. CAPA: Corrective action and Preventive Action
5.2. RCA: Route cause analysis
6. References: In-house, Regulatory guidelines

Sr. No. Revision No. Date of issue Reason for change

1 0 01.08.2012 Original issue of Document

2 1 01.04.2015 All the documents revised in line with global change of

documentation system.
3 2 01.04.2018 Entire manual revised as per ISO 9001 :2015 requirements.

4 3 04.04.2020 Entire manual revised as per ISO 22716 :2007 requirements.

5 4 30.03.2023
Entire manual issued as per EFfCI GMP requirements

Owned by Approved by Issued By

Leader-Quality Process Head-Quality Process / Managing Director Management Representative

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