PV0011_Procedure for Corrective and Preventive Action (CAPA) processes for pharmacovigilance (002) (002)

STANDARD OPERATING PROCEDURE
Title: Procedure for Corrective and Preventive Action SOP No. COS/PV/011
(CAPA) processes for pharmacovigilance
Revision No. 00 Supersedes NIL
Department Regulatory Affairs Page No. Page 1 of 21
Effective Date Review Date
1.0 OBJECTIVE:
To lay down the procedure for identifying, investigating, and implementing corrective
and preventive actions (CAPA) for pharmacovigilance activities at Cospharm
Pharmaceuticals. It ensures timely and effective responses to potential or identified
drug safety concerns associated with our marketed generic medicines.
2.0 SCOPE:
This procedure applies to all personnel involved in pharmacovigilance activities, including:

• Pharmacovigilance team
• Quality Assurance (QA) department
• Manufacturing department
• Regulatory affairs department
3.0 RESPONSIBILITY:
Designation Responsibilities
QPPV  Oversees the CAPA process for pharmacovigilance.
 Reviews all identified potential or actual deviations
related to pharmacovigilance.
 Determines the need for a CAPA investigation and
assigns responsibility for the investigation.
 Reviews and approves proposed corrective and
preventive actions.
 Ensures implementation and effectiveness of CAPAs.
 Maintains records of all CAPA activities.
RA Department  Coordinates communication with regulatory authorities
regarding CAPA actions for pharmacovigilance issues.
RA, Production, QA,  Participate in the investigation of potential or actual
Prepared By Checked By Approved By

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Designatio RA Officer QPPV QA Pharmacist
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Departmen Regulatory Affairs Regulatory Affairs Quality Assurance
t
Format No.: COS/QAD/001/F01-01
Designation Responsibilities
PV, RND, QMS deviations related to pharmacovigilance.
 Recommend corrective and preventive actions.
departmental
 Document their findings and recommendations.
personnel
QA Pharmacist  Provide oversight and guidance on the CAPA process.
 Review and approve CAPA procedures.
 Ensure CAPA records are maintained according to
regulatory requirements
Production Implement corrective and preventive actions related to
manufacturing processes.
manager
4.0 ACCOUNTABILITY:
Qualified persons for Pharmacovigilance (QPPV) is accountable for compliance of the
system.
5.0 PROCEDURE:
5.1 Definitions:
5.1.1 Correction: Action to eliminate a detected non-conformity A correction can be
made in conjunction with a corrective action.
5.1.2 Corrective Action: An action to eliminate the cause of a detected non-conformity or

other undesirable situation. Corrective action is taken to prevent recurrence
and is a reaction to a problem that has already occurred.
5.1.3 Preventative Action: An action to eliminate the cause of a potential non-

conformity or other undesirable situation. Preventative action is taken to
prevent occurrence.
5.1.4 Adverse Drug Reaction (ADR): A response to a drug which is noxious and
unintended, and which occurs at doses normally used in man for the prophylaxis,
diagnosis, or therapy of disease, or for the modifications of physiological function.
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5.1.5 Adverse Event (AE): An adverse event/experience is any untoward medical

occurrence in a patient or clinical trial subject administered a medicinal product
that may present during treatment with a medicine, but which does not necessarily
have a causal relationship with this treatment.
5.1.6 Qualified Persons for Pharmacovigilance: An individual named by the Marketing

Authorization Holder (MAH) and approved by the Authority as the person
responsible for monitoring of the safety of the products marketed by the MAH in
Zimbabwe.
5.2 Procedure
5.2.1 Identification of Potential or Actual Deviations

5.2.1.1 Potential or actual deviations related to pharmacovigilance can be identified
through various sources, including:
5.2.1.1.1 ADR reports received from healthcare professionals, patients, or consumers.
5.2.1.1.2 Trends or patterns observed in spontaneous reporting data
5.2.1.1.3 Regulatory agency reports or communications of suspected safety issues.
5.2.1.1.4 Scientific literature on potential safety concerns associated with our
products or similar generic medicines.
5.2.1.1.5 Internal audits of pharmacovigilance activities.
5.2.2 Evaluation of Potential Pharmacovigilance Deviations

5.2.2.1.1 The pharmacovigilance team is responsible for reviewing all sources of
information to identify potential pharmacovigilance issues
5.2.2.1.2 The Pharmacovigilance Officer will review all identified potential or
actual deviations to determine the need for a CAPA investigation.
5.2.2.1.3 Once a potential pharmacovigilance issue is identified, the
pharmacovigilance team will assess its severity and likelihood. This
assessment will consider factors such as:
 The severity of the potential or actual ADR.
 The frequency of the reported ADR.
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 The plausibility of the association between the product and the ADR.
 The potential public health impact.
5.2.2.2 Based on the assessment, the pharmacovigilance team will determine the
appropriate course of action, which may include:
5.2.2.2.1 Initiation of a CAPA process.
5.2.2.2.2 Further investigation to gather more information.
5.2.2.2.3 No action, if the potential issue is deemed to be low risk.
5.2.3 CAPA Determination and Implementation

5.2.3.1 If a CAPA process is initiated, the pharmacovigilance team will lead a cross-
functional investigation involving relevant departments (e.g., QA, RND, QMS,
Manufacturing, Regulatory Affairs). The investigation will aim to identify the
root cause of the potential pharmacovigilance issue.
5.2.3.2 Documentation and reporting

5.2.3.2.1 All steps of the CAPA process will be documented, including:.
 Description of the potential pharmacovigilance issue.
 Assessment of the issue.
 Investigation findings.
 Determined corrective and preventive actions.
 Implementation plan for CAPA actions.
 Follow-up activities
5.2.4 CAPA Investigation

5.2.4.1.1 If a CAPA investigation is deemed necessary, the Pharmacovigilance
Officer will assign a team to conduct the investigation. The
investigation should include:
 Description of the potential pharmacovigilance issue
 Reviewing all available information related to the deviation, including
ADR reports, product information, and manufacturing records.
 Identifying the root cause of the deviation.

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 Determining the potential impact of the deviation on patient safety.

 Developing and proposing corrective actions to address the root cause
of the deviation.
 Developing and proposing preventive actions to prevent similar
deviations from occurring in the future.
 Implementation plan for CAPA actions.
 Follow-up activities
5.2.5 CAPA Implementation

5.2.5.1 Based on the investigation findings, the team will determine and implement
appropriate corrective and preventive actions. Corrective actions may
address immediate concerns, such as revising product labeling or recalling a
specific batch. Preventive actions aim to prevent future occurrences, such as
implementing process improvements in manufacturing.
5.2.5.2 The Pharmacovigilance Officer will review and approve the proposed
corrective and preventive actions. Once approved, the actions will be
implemented in a timely manner. The implementation may involve:
5.2.5.2.1 Corrective Actions:
o Recalling or withdrawing a product from the market.
o Revising product labeling to include new safety information.
o Implementing changes to manufacturing processes.
o Conducting additional product testing
5.2.6 Training
5.2.6.1 It is the responsibility of the QPPV, in conjunction with QA Pharmacist to
ensure that all personnel involved in the CAPA are trained on the procedure
and that periodic revision for existing representatives occurs. When new
perssonnel start, the designated person must be advised of additional
training required e.g. to be scheduled at pre-cycle meetings. Relevant staff
within Cospharm Pharmaceuticals and Seasons Pharmaceuticals will be
trained on the importance of CAPA.
5.2.6.2 A record of staff trained in all departments shall be kept by the QA and QMS
pharmacist.
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5.2.7 Auditing
5.2.7.1 Internal in-house auditing will be organized by the QA and QMS pharmacist
as per self-audit SOP.
5.2.7.2 Findings from the Audit will be kept on record and used for inhouse PV
system improvement.
6.0 ANNEXURE:
Annexure No. Title of Annexure Format No.

Cospharm Pharmaceuticals – COS/PV/011/F01-00
Annexure I Pharmacovigilance CAPA Process Recording
Template
Cospharm Pharmaceuticals Adverse Event: COS/PV/011/F02-00
Annexure II
NRA Reporting Form
Cospharm Pharmaceuticals Reduced COS/PV/011/F03-00
Annexure III
Efficacy Report Form
Cospharm Pharmaceuticals Sales COS/PV/011/F04-00
Annexure IV
Representative’s Adverse Event Form
7.0 SAFETY PRECAUTION:

N/A
8.0 ABBREVIATIONS
SOP : Standard Operating Procedure

QC : Quality Control
No. : Number
N/A : Not Applicable
MCAZ : Medicines Control Authority of Zimbabwe
RA : Regulatory Affairs
QPPV : Qualified Persons for Pharmacovigilance
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9.0 SOP DISTRIBUTION:
S. No. Department Copy No. Controlled Copy

(For office use)/Display Copy
1. QA Pharmacist 01 Controlled Copy
2. QMS 02 Controlled Copy
3. RA/PV 03 Controlled Copy
4. RND 04 Controlled Copy
5. General Manager Cospharm 05 Controlled Copy
6. Marketing Manager 06 Controlled Copy
7. Production Pharmacist 07 Controlled Copy
10.0 CROSS REFERENCE SOP (S):
 COS/QAD/008_Procedure for handling market complaints

 COS/QAD/009_Procedure for handling product recalls
 COS/PV/007_Procedure for Pharmacovigilance Market Complaints
and AER/ADR processing.
11.0 CHANGE HISTORY:
N/A
12.0 REFERENCES:
 MCAZ-PVCT-GL02-Rev-1_February 2022- PHARMACOVIGILANCE GUIDELINE FOR

PHARMACEUTICAL INDUSTRY
 ICH Guidelines for Good Pharmacovigilance Practice
https://admin.ich.org/sites/default/files/inline-files/E2B_R2_Guideline.pdf
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 MCAZ Circular 7/98 on Reporting of Medicinal Product Defect.

 WHO Draft Guidelines for Adverse Event Reporting and Learning Systems: From
Information to Action 2nd edition, December 2016
 Zimbabwe National Pharmacovigilance Policy Handbook (2nd Edition December
2016).

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 Annexure I: Cospharm Pharmaceuticals – Pharmacovigilance CAPA Process

Recording Template
Reference Number: [Unique identifier for this CAPA process]
Date Opened: [Date the CAPA process was initiated]
1. Identification of Potential Pharmacovigilance Issue (Responsibility PV Team)

Briefly describe the identified potential pharmacovigilance issue (e.g., type of adverse
event, source of information).
 Source of Information: (e.g., Adverse event report, Regulatory communication)

 Brief Description of Issue: (Summarize the potential problem)
2. Assessment of Potential Pharmacovigilance Issue (Responsibility PV Team)

Summarize the assessment of the issue (e.g., severity, likelihood, potential causality).
 Severity of Adverse Events (if applicable): (e.g., Mild, Moderate, Severe)

 Frequency of Reported Events: (Number of reports, timeframe)
 Suspected Causal Relationship: (Plausible, Likely, Unlikely)
 Overall Risk Assessment: (Low, Medium, High)
3. CAPA Determination (Outline the determined corrective and preventive actions.

(e.g., specific actions, timelines). (Responsibility: Cross-functional Team) Outline the
determined corrective and preventive actions. (e.g., specific actions, timelines).

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 Initiate CAPA Process? (Yes/No)

 Justification for Decision: (Explain why or why not a CAPA is needed)
4. Investigation (Responsibility: Assigned Department(s))

Record the implementation details of the corrective and preventive actions.
 Team Members Involved: (List personnel from relevant departments)
 Investigation Activities: (Describe actions taken to identify root cause)

Root Cause Identified: (Explain the underlying reason for the issue)
5. Corrective Actions (Responsibility: Assigned Department(s))

 Action Description: (Detail the specific steps to address the immediate issue)
 Responsible Department: (Assign ownership for implementing the action)

Completion Date: (Target date for completing the corrective action)
6. Preventive Actions (Responsibility: Assigned Department(s))

 Action Description: (Detail the steps to prevent future occurrences)
 Responsible Department: (Assign ownership for implementing the action)

 Completion Date: (Target date for completing the preventive action)
7. Documentation and Reporting (Responsibility: Assigned Department(s))

 Attached Documents: (List any reports, data analysis, or communication records)
 Reporting to Regulatory Authorities (if applicable): (Yes/No)

 Date Reported: (If applicable)
8. Follow-up (Responsibility: QA and PV)

 Verification of Corrective Action Completion: (Confirm implementation)

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 Monitoring of Preventive Action Effectiveness: (Describe how to assess success)

CAPA Process Closure Date: (Date the process is considered complete)
Closure of CAPA (Comments)
QPPV:
Date:_______/________/________ (dd/mm/yy)
Name:________________________________________________
(please print)
Signature:____________________________
Head of Quality Assurance:

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Date:_______/________/________ (dd/mm/yy)
Name:________________________________________________
(please print)
Signature:____________________________
General Manager:
Date:_______/________/________ (dd/mm/yy)
Name:________________________________________________
(please print)
Signature:____________________________
COS/PV/011/F01-00

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Annexure 2: Cospharm Pharmaceuticals Adverse Event: NRA Reporting Form

A. PATIENT INFORMATION
Patient name : Age: Heigh
M F . Inpatient Y N
Sex: t:
Company name: Weig
. Hospital No:
Pregnant (wks) ht:
B. ADVERSE EVENT INFORMATION
Seriousness of event:
Adverse Event: Death Congenital

anomaly
Persistent or
Date of onset: _____/_____/____ Duration: Life threatening: significant
(hrs) (min) disability
DD MM YY /incapacity
Hospitalisation Requires
Time interval between last dose and onset of event: Initial or - intervention
(hrs) (min) prolonged to prevent one
of the above
Describe course of AE, symptoms and treatment: Outcome of event:
Recovered with
sequelae
Recovering
C. SUSPECT DRUG OR DEVICE INFORMATION

Name Batch Model Expiry Rout Dail Duration of Therapy Indication
(Dosage Numb No &/or Date e y Date Date for Use
form & er Serial No (e.g. Dos started stopped
strength p.o.) age
e.g. syrup
5mg/100m

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_____/____ ____/_____/____
____/_____/____
MM DD DD
YY MM YY MM YY
Event abated after Event reappeared on N
Y N Y N
stopping product rechallenge A
Event abated after N Product available for
Y N Y N
reducing dose A testing
Casual relationship: Probable Possible Unlikely Unrelated

YE NO
S
D. CONCOMITANT MEDICATION INFORMATION (Used in the 3 months preceding AE
excluding treatment of event)
Duration of Therapy
Name (Dosage form & Route Daily Indication for
Date Date
strength) (E.g.po.) Dosage Use
started stopped
____/_____/____
____/_____/____
DD MM DD
YY MM YY
____/_____/____
____/_____/____
DD MM DD
YY MM YY
____/_____/____
____/_____/____
DD MM YY DD MM YY
____/_____/____
____/_____/____
DD MM YY DD MM YY
____/_____/____
____/_____/____
DD MM YY DD MM YY
____/_____/____
____/_____/____
DD MM YY DD MM YY
E. RELEVANT LABORATORY TESTS

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Performed:
Specify tests performed and results (attach if
available)_________________________________________________________________
________________
_________________________________________________________________________
________________________________________________________________
F. PATIENT HISTORY – (including pre-existing medical conditions (Allergies, pregnancies,

smoking & alcohol abuse, family history etc)
G. REPORTING HEALTHCARE PROFESSIONAL’S DETAILS

Name:____________________________________________
Profession:____________________________Tel:______________________
Fax:_____________________
Address:__________________________________________________________________
____________________________ Signature:____________________________
H. MANUFACTURING INFORMATION (for office use only)
Report Source: Company Rep Health Professional

Lawyer Literature
Consumer Foreign
Other
Name of Cospharm Pharmaceuticals personnel completing form:
Name (Print):_________________________________________
Date:________________________ Signature:____________________
COS/PV/011/F02-00 Page X of Y

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Annexure 3: Cospharm Pharmaceuticals Reduced Efficacy Report Form

A. PATIENT INFORMATION
Patient name :
M F Height: . Inpatient Y N
Age: Sex:
Company name: Weight
. Hospital No:
Pregnant (wks) :
B. MEDICATION AND PROCEDURE INFORMATION
Name of Medication:
Batch No: Expiry Date: Route:
Single (e.g. x ml) Describe
Repeated
Continuous infusion
Other:
Additions/dilution No If ‘Yes’ describe:

Yes
(e.g.) Of other drugs)
Procedure Undertaken: Type of needle used:
Type of Blockage: Infiltration Epidural Spinal

Intravenous regional block
Intraligamentary Nerve block Topical Dental

nerve block Dental Infiltration
Other
Time Interval Before:
No efficacy Mins Tests Done:
Partial efficacy Mins Tests Done:
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Action Taken:
Procedure completed without further medication General Anaesthesia used

instead Abort procedure
Further
Result:
dosage
Different Specify with
agent Results
Outcome:
C. CONCOMITANT MEDICATION INFORMATION (Used in the 3 months preceding AE

excluding treatment of event
Route Duration of Therapy
Name (Dosage form & Daily Indication for
(E.g.po. Date Date
strength) Dosage Use
) started stopped
____/_____/____
____/_____/____
DD MM DD
YY MM YY
____/_____/____
____/_____/____
DD MM DD
YY MM YY
____/_____/____
____/_____/____
DD MM YYDD MM YY
____/_____/____
____/_____/____
DD MM YYDD MM YY
____/_____/____
____/_____/____
DD MM YYDD MM YY
D. PATIENT HISTORY – (including pre-existing medical conditions (Allergies, pregnancies,
smoking & alcohol abuse, family history etc)
E. OPERATOR DETAILS

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Specialist: Yes If Yes, time since registration:

No
Profession:
Name:
Signature:
Tel: Fax: Date:

_______/_______/______
DD MM YY
F. MANUFACTURER INFORMATION (for office use only)
Report Source: Company Rep Health Professional

Lawyer Literature
Consumer Foreign
Other
Name of Cospharm Pharmaceuticals personnel completing form:
Name (Print):_________________________________________
Date:________________________________ Signature:____________________

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Annexure 4: Cospharm Pharmaceuticals Sales Representative’s Adverse Event Form
Email To:_____________________________________ Email

Address.:____________________ (Tick applicable boxes)
Patient
Gender
Name:___________________
Country where event Age /Approx.
___
occurred Date of birth Male
___________ Female
Hospital
__________________ ____
No.:_________________
______
Describe Adverse Event: Seriousness of Event:
Date (approx) of onset of reaction: Death

___________________________________
Life threatening
Duration of reaction:
______________________________________________ Hospitalisation-Initial or
prolonged
Suspected Medication / Device:
Persistant or significant
disabibilty /incapacity
Name.....................................................................................
Congenital anomaly

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................................
Required intervention to
prevent
Dosage Form:___________Batch No:___________ Exp permanent
Date: ______/______ impairment/damage
Outcome of Event:
mm yy
Recovered with residual
effects
Available for evaluation : Yes No
Recovered with no
residual effects
Still under treatment for

reaction
Reporting Healthcare Professional’s Details:

Company Representative’s
Details:
Name:__________________________________________
_______________ Name:_____________________
_________
Profession Division:
(speciality):______________________________________ __________________________
______ __
Territory:
Address:________________________________________ __________________________
_______________ _
_______________________________________________ Date reported / faxed to Datlabs:

_______________
_______/_______/______
Tel:____________________________________________ dd mm yy

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Fax:____________________________________________ Signature:
__________________________
COMMENTS:
___________________________________________________________________________
__________________________
___________________________________________________________________________
__________________________
___________________________________________________________________________
__________________________
___________________________________________________________________________
__________________________
___________________________________________________________________________
__________________________

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STANDARD OPERATING PROCEDURE

This procedure applies to all personnel involved in pharmacovigilance activities, including:

Prepared By Checked By Approved By

5.1.2 Corrective Action: An action to eliminate the cause of a detected non-conformity or

5.1.3 Preventative Action: An action to eliminate the cause of a potential non-

5.1.5 Adverse Event (AE): An adverse event/experience is any untoward medical

5.1.6 Qualified Persons for Pharmacovigilance: An individual named by the Marketing

5.2.1 Identification of Potential or Actual Deviations

5.2.2 Evaluation of Potential Pharmacovigilance Deviations

5.2.3 CAPA Determination and Implementation

5.2.3.2 Documentation and reporting

5.2.4 CAPA Investigation

Prepared By Checked By Approved By

 Determining the potential impact of the deviation on patient safety.

5.2.5 CAPA Implementation

Annexure No. Title of Annexure Format No.

7.0 SAFETY PRECAUTION:

SOP : Standard Operating Procedure

9.0 SOP DISTRIBUTION:

S. No. Department Copy No. Controlled Copy

10.0 CROSS REFERENCE SOP (S):

 COS/QAD/008_Procedure for handling market complaints

11.0 CHANGE HISTORY:

 MCAZ-PVCT-GL02-Rev-1_February 2022- PHARMACOVIGILANCE GUIDELINE FOR

 MCAZ Circular 7/98 on Reporting of Medicinal Product Defect.

Prepared By Checked By Approved By

 Annexure I: Cospharm Pharmaceuticals – Pharmacovigilance CAPA Process

1. Identification of Potential Pharmacovigilance Issue (Responsibility PV Team)

 Source of Information: (e.g., Adverse event report, Regulatory communication)

2. Assessment of Potential Pharmacovigilance Issue (Responsibility PV Team)

 Severity of Adverse Events (if applicable): (e.g., Mild, Moderate, Severe)

3. CAPA Determination (Outline the determined corrective and preventive actions.

Prepared By Checked By Approved By

 Initiate CAPA Process? (Yes/No)

4. Investigation (Responsibility: Assigned Department(s))

 Investigation Activities: (Describe actions taken to identify root cause)

5. Corrective Actions (Responsibility: Assigned Department(s))

 Responsible Department: (Assign ownership for implementing the action)

6. Preventive Actions (Responsibility: Assigned Department(s))

 Responsible Department: (Assign ownership for implementing the action)

7. Documentation and Reporting (Responsibility: Assigned Department(s))

 Reporting to Regulatory Authorities (if applicable): (Yes/No)

8. Follow-up (Responsibility: QA and PV)

Prepared By Checked By Approved By

 Monitoring of Preventive Action Effectiveness: (Describe how to assess success)

Closure of CAPA (Comments)

Head of Quality Assurance:

Prepared By Checked By Approved By

Prepared By Checked By Approved By

Annexure 2: Cospharm Pharmaceuticals Adverse Event: NRA Reporting Form

Adverse Event: Death Congenital

C. SUSPECT DRUG OR DEVICE INFORMATION

Prepared By Checked By Approved By

Casual relationship: Probable Possible Unlikely Unrelated

Prepared By Checked By Approved By

F. PATIENT HISTORY – (including pre-existing medical conditions (Allergies, pregnancies,

G. REPORTING HEALTHCARE PROFESSIONAL’S DETAILS

Report Source: Company Rep Health Professional

Name of Cospharm Pharmaceuticals personnel completing form:

Prepared By Checked By Approved By

Annexure 3: Cospharm Pharmaceuticals Reduced Efficacy Report Form

Single (e.g. x ml) Describe

Additions/dilution No If ‘Yes’ describe:

Type of Blockage: Infiltration Epidural Spinal