KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.

TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102

FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 1 of 14

SCOPE /PURPOSE : To establish the methodology for taking and monitoring corrective
action and preventive action (CAPA) on identified non-conformances
through analysis of quality records.
APPLICATION : This procedure applies to internal and external problems relating to
quality, safety or efficacy of any finished pharmaceutical products
produced by KPI (1996) Ltd.
DEFINITIONS : Corrective Action: Action to eliminate the cause (s) of the detected
non-conformance or any other undesirable situation to avoid
recurrence.
Preventive Action: Action to eliminate the cause of the potential non-
conformity or any other undesirable potential situation.
Effectiveness check of CAPA: Any corrective or preventive action
assessed for the effectiveness in preventing or reducing repetitive
occurrences of similar nature.
Remedial action: An action taken to alleviate the symptoms of
existing nonconformity or any other undesirable situation
Root cause: A fundamental deficiency that results in a non-
conformance and must be corrected to prevent recurrence of the
similar non-conformance.
Corrective Action Severity: this refers to the criticality of the
corrective action and it is determined by the following guidelines:
Critical – related to product safety, HSE or regulatory issue.
Major – related to a failure of a product, process or system but will not
impact safety of the product.

WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 2 of 14

ABBREVIATIONS : QA - Quality Assurance.

SOP - Standard Operating Procedure.
CAPA - Corrective Action and Preventive Action
GMP - Good Manufacturing Practices.
OOS - Out Of Specifications

ANNEXURES : Annexure I – CAPA request form

Annexure II – CAPA log
Annexure III – Corrective action and prevention action form
Annexure IV –CAPA implementation plan format
Annexure V- CAPA process flow
MATERIALS : Source documents
RESPONSIBILITIES : The QA Manager is responsible for establishing, implementing, and
maintaining the ongoing effectiveness of the corrective action/
preventive action (CAPA) system.
All employees have the responsibility to initiate corrective/preventive
action requests as it relates to their job functions. Any employee can
request that a CAPA be opened.
Top Management is responsible for assigning CAPA and resources
based on the severity and / or trending data of the process or product
issue.

DISTRIBUTION : All department heads

PROCEDURE : 1.0 Opening of CAPA.
The groups below represent possible reasons for initiating a
corrective / preventive action. Corrective actions may be initiated to
WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 3 of 14

address any other issues where a corrective / preventive action is

necessary
1.1 Complaints: A CAPA shall be issued to address trends
involving customer complaints. The issuance of a CAPA will
depend on the severity and / or frequency of the complaint.
1.2 Non-conformances: A CAPA can be issued to address
repeat non-conformances or to address trends involving non-
conformances. The issuance of a CAPA shall depend on the
severity and / or frequency of the non-conformance.
1.3 GMP / Quality audits: Audit findings from internal and
external GMP / Quality inspections will be assigned a
corrective action. This CAPA will be assigned to the
department that was audited. A file of audit corrective actions
will be maintained separately from the files of other corrective
actions.
1.4 Supplier / Subcontractor Control: Suppliers and
subcontractors who perform below expected levels require a
CAPA to address their deficiencies. This type CAPA is also
called Supplier Corrective Action Request report will be
assigned to the vendor.
1.5 Management Review: During management review,
management may issue a CAPA to address a deficiency or
tend identified. This CAPA will be assigned to the department
that is most responsible for the deficiency or trend.
1.6 Closing of a CAPA: The CAPA must contain a thorough
WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 4 of 14

investigation and documentation for all sections of the CAPA.

All data and analysis should be put in measurable terms to
support the corrective action and future verifications.
1.7 Closing of CAPAs: A proposed due date will be agreed upon
between Management or QA Manager and the head of the
concerned department. A onetime extension of the proposed
due date can be requested and must be approved by the CEO.
2.0 Initiation of CAPA.
2.1 After establishing the root cause of the non-conformance
or risk assessment, a corrective action / preventive action
shall be initiated by the concerned department.
2.2 The head of the concerned department shall document
the CAPA by filling the CAPA request form (ANX-I)
issued by QA.
2.2.1 The head of the concerned department / CAPA
Owner describe the actual non-conformance,
including its source of the non-conformance,
severity and any other related information.
2.2.2 Containment action. Identify the action taken to
isolate the non-conformance immediately.
2.2.3 Identify the root cause through root cause
analysis. Document the root cause tools used
such as Why-Why analysis, Fish Bone
analysis, Failure Mode and Effect analysis
(FMEA) etc.
WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 5 of 14

2.2.4 Identify the corrective measure (s) to address

the root cause of the identified root issue as
identified in the root cause analysis.
2.3 The department head / CAPA owner shall return the filled
CAPA request form to QA.
2.4 The QA Manager shall then assess the proposed CAPA
for its adequacy, effectiveness and completeness before
approving it.
2.5 In cases where the CAPA requires capital expenditure,
approval of the CEO shall be required.
2.6 The approved CAPA shall then be allotted a reference
number and registered in the CAPA log (ANX –II).
Numbering shall be done as follows; CAPA/XXX/YYY/Z
where:
 XXX denote department code,
 YYY denote serial number commencing,
 Z denote the last two digits of the calendar year
For example CAPA/PRD/007/19 represents the 7 th CAPA
from production department in the year 2019.
2.7 The QA Manager / designee shall then forward the
“CAPA request form” back to the concerned department
head / CAPA owner for him / her to propose CAPA
implementation and closure dates.
The closure date shall be agreed between the CAPA
Owner and the QA Manager.
WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 6 of 14

3.0 CAPA Implementation and Closure :

3.1 CAPA shall be implemented and closed within the
agreed timeline. In case of any delay or extension in
agreed time line, justify the delay with resultant
consequences if any and state the new agreed time line.
3.2 On implementation of actions , the department head
/HOD’s shall review the implementation details in the
“CAPA FORM “and shall forward to QA for CLOSURE.
3.3 QA head / designee shall review the implementation
status and evaluate if the CAPA implementation was
done satisfactorily as planned. QA Manager shall close
the CAPA if it was satisfactorily implemented.

4.0 Handling of legacy documents ( CAPA)

CAPA records on paper shall be completed promptly
4.1 The details of paper document of CAPA shall be transcribed
in Excel sheet i.e CAPA FORMAT ( ANX –III)
4.2 “CAPA FORM” shall be issued by QA with CAPA NUMBER.
4.3 If the implemented CAPA is not effective i.e similar non-
compliance is reported after closure of the CAPA, then the head of
the concerned department and QA Manager shall re- investigate
the non-conformance and gap analysis shall be performed to detect
the in-efficiencies in the corrective and prevention actions.
4.4 “CAPA FORM “ shall be forward to QA head for review and
comment
WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 7 of 14

4.5 The status and trending of the CAPA shall be part of management
review.
4.6 Any change proposed as a result of the CAPA shall be done
through the “SOP for change control “and reference of the same
shall be mentioned in the” CAPA FORM”.
4.7 All deviations, discrepancies, giving rise to CAPA shall be
addressed through the “CAPA FORM “.
4.8 All facility up grades/capital purchase requirements/major changes
in the quality system for compliance to regulatory commitments
giving rise to CAPA shall be addressed through the “CAPA
FORM “.
4.9 The record of each CAPA shall be maintained and copy of
completed CAPA shall be provided to the concerned department
head by QA department. A copy of “CAPA FORM “shall be
attached to the source document.
4.10 Department heads shall compile the CAPA Information and
submit the summary to management during the GMP Committee
meeting/management meeting.
4.11 Management shall review or verify the same in management
meetings.
4.12 Information and documents related to CAPA drawn from internal
audits, external/customer audits and regulatory inspections are
considered confidential and shall only be made for regulatory
review on approved by QA Manager and / or Company pharmacist.
4.13 The time frame for implementation and completion of a specific
WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 8 of 14

CAPA resulting from both internal and external inspection shall be

agreed on in the management meeting discussing audit reports.
4.14 Any deviation from this SOP shall be handled as per SOP
For deviation control.
4.15 CAPA shall be categorised by Major, Minor and Critical
Non-conformances.

Note: Source documents include but not limited to:

 GMP investigations,
 deviations,
 laboratory investigations,
 batch failures ,
 OOS,
 Discrepancies in labelling,
 internal audits,
 external/customer audits,
WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 9 of 14

 regulatory inspection reports,

 product failures,
 product recall,
 annual product review,
 product complaints,
 returned goods,
 incident reports,
 quality index/quality metrics,
 equipment/instrument qualification and calibration ,
 risk assessment ,
 Technology transfer documents,
 SOP review, environment and safety ,
 QC stability reports,
 warehousing,
 periodic trends and reviews,
 management action plan,
 changes in regulatory or pharmacopoeia requirements and
 any other non-compliances documents

Annexure I: CAPA REQUEST FORM

Department CAPA No: Date

Description of non-
conformance / problem
observed.
Containment action taken
WRITTEN BY APPROVED BY

CauseQA SUPERVISPOR
of the non- COMPANY PHARMACIST QA MANAGER

conformance/ problem

Root cause of the non-

conformance / problem
Proposed Corrective action /
 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 10 of 14

WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 11 of 14

Annexure II CAPA LOG

Date
ce
conforman
of Non-
DescriptionCause
conformance
of Non-
Root cause
action
Preventive
Corrective /
No:
CAPA
d by
Recorde
Closure
CAPA
Date
by &
Closure
CAPA Remark

WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 12 of 14

Annexure III : Corrective Action Report

KPI (1996) LTD

CORRECTIVE ACTION REPORT Date:
Department/ Section
CAR No.
( Assigned by QA)

Description Non-Conformance:

Corrective Action

Date For Completion Of Corrective Action

CAPA Owner (signature and date):

Prevent Action:

Date For Completion of Action:

Head of Department (signature &date)

Follow-Up & Close Out

Proposed Follow-Up Date

Follow-Up Details

CAR Close-Out Date QA Manager (signature &date)

WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 13 of 14

Annexure IV: CAPA IMPLEMENTATION PLAN

Date:

No
identified
/ problem
conformance
Non-
Action
Preventive
Corrective /
CAPA
of
gory
Cate
frame
Time
Owner
CAPA
closed
ented &
Implem

Corrective / Preventive Action

nted
Impleme
Partially
ented
Implem
Not

Remarks

WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER

 KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: STANDARD OPERATING PROCEDURE SOP NO. : QAC-102
FOR CORRECTIVE ACTION AND SUPERCEDES : N/A
PREVENTIVE ACTION EFFECTIVE DATE : 30-04-2019
REVIEW DATE : 30-04-2024
PAGE : 14 of 14

ANNEXURE V: CAPA PROCESS

Non- Vendor Management

Complaints Audit findings
conformance /Subcontractor review

Initiate No Continue to
CAPA? monitor

Yes

Fill CAPA NO
request form

Describe Non-
Conformance

Implement a
containment action

Root cause analysis

CAPA Closure

Propose CAPA

Implement CAPA &

follow up

WRITTEN BY APPROVED BY

QA SUPERVISPOR COMPANY PHARMACIST QA MANAGER