STANDARD OPERATING PROCEDURE

Title: Procedure for Archiving and Retrieval of SOP No. COS/PV/013

Individual Case Safety Reports (ICSRs)
Revision No. 00 Supersedes N/A
Department Regulatory Affairs Page No. Page 1 of 7
Effective Date Review Date

1.0 OBJECTIVE:
To lay down the procedure for archiving and retrieving Individual Case Safety Reports
(ICSRs) received by Cospharm Pharmaceuticals in accordance with pharmacovigilance
regulations.

2.0 SCOPE:
This procedure applies to all personnel involved in receiving, processing, archiving, and
retrieving ICSRs related to Cospharm Pharmaceuticals' products.
3.0 RESPONSIBILITY:
Designation Responsibilities
Regulatory Officer  Shall be responsible for overseeing and ensuring full
(QPPV)/ Deputy compliance of the pharmacovigilance system
QPPV/Chosen  Is responsible for training, investigating, and
Designate coordinating the management of Pharmacovigilance
activities within Cospharm Pharmaceuticals.
 Shall be responsible for archiving and retrieving
Individual Case Safety Reports (ICSRs)
 Shall be responsible for investigating and ensuring that
all adverse events reported were appropriately
investigated, resolved and closed.
 Communicating any ISCRs to the regulatory agency

4.0 ACCOUNTABILITY:

Qualified persons for Pharmacovigilance (QPPV) is accountable for compliance of the

system.

5.0 PROCEDURE:
5.1 Definitions:
5.1.1 Individual Case Safety Report (ICSR):: An authorized written procedure, giving
instructions for performing operations, not necessarily specific to a given product or
material, but of a more general nature (e.g. operation of equipment, maintenance

Prepared By Checked By Approved By

Signature
Date
Designatio RA Officer QPPV QA Pharmacist
n
Departmen Regulatory Affairs Regulatory Affairs Quality Assurance
t
Format No.: COS/QAD/001/F01-01
 STANDARD OPERATING PROCEDURE

Title: Procedure for Archiving and Retrieval of SOP No. COS/PV/013

Individual Case Safety Reports (ICSRs)
Revision No. 00 Supersedes N/A
Department Regulatory Affairs Page No. Page 2 of 7
Effective Date Review Date

and cleaning, validation, cleaning of premises and environmental control, sampling

and inspection).

5.1.2 Archiving: The process of storing ICSRs in a secure and accessible manner for a
defined period.

5.1.3 Retrieval: The process of locating and accessing archived ICSRs for various purposes
(e.g., pharmacovigilance activities, regulatory inquiries).
5.1.4 Adverse Drug Reaction (ADR): 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.

5.1.5 Unexpected Adverse Drug Reaction: An adverse reaction, the nature or severity of
which is not consistent with applicable product information or labelling or expected
from the characteristics of the medicine.

Reports that add significant information on specificity or severity of a known,

already documented serious adverse drug reaction constitute unexpected events.
For example, an event more specific or more severe than described in the package
insert would be considered “unlabeled” (unexpected). A specific example would be
acute renal failure as a labelled adverse drug reaction with a subsequent new
report on interstitial nephritis.

5.1.6 Signal: Reported information on a possible causal relationship between an adverse

event and drug, the relationship being unknown or incompletely documented
previously. Usually more than one report is required to generate a signal,
depending upon the seriousness of the event and the quality of the information.

5.1.7 Serious Adverse Event Or Reaction (SAER): An adverse reaction or event which
results in death, is life-threatening, requires in-patient hospitalization or
prolongation of existing hospitalization, results in persistent or significant disability
or incapacity, or is a congenital anomaly/birth defects.

Prepared By Checked By Approved By

Signature
Date
Designatio RA Officer QPPV QA Pharmacist
n
Departmen Regulatory Affairs Regulatory Affairs Quality Assurance
t
Format No.: COS/QAD/001/F01-01
 STANDARD OPERATING PROCEDURE

Title: Procedure for Archiving and Retrieval of SOP No. COS/PV/013

Individual Case Safety Reports (ICSRs)
Revision No. 00 Supersedes N/A
Department Regulatory Affairs Page No. Page 3 of 7
Effective Date Review Date

5.1.8 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 ICSR Receipt and Processing

5.2.1.1 ICSRs can be received from various sources, including healthcare
professionals, patients, consumers, or regulatory authorities.
5.2.1.2 Upon receipt, a unique identifier will be assigned to each ICSR in an electronic
log.
5.2.1.3 Numbering System for 'Market Complaint Investigation Report' Number shall
be allocated as COS/PV/ISCR/Sr. No. / Year. In-line with the
pharmacovigilance log book serial No. (e.g. COS/PV/ISCR/001/2011).
5.2.1.4 Where,
5.2.1.4.1 COSPV : Cospharm Pharmaceuticals Pharmacovigilance
5.2.1.4.2 ISCR : Individual subject case report
5.2.1.4.3 001 : Serial number shall be started from 001 (Every year should be
start with 001)
5.2.1.4.4 2011 : Full digits of current Calendar Year

5.2.2 Archiving Procedures

5.2.2.1 Apart from the MCAZ pharmacovigilance ADR and SAE platform, MCAZ e-PV
system ICSRs will be archived in a secure and electronic format (e.g.,
dedicated database, document management system) on Cospharm server.
5.2.2.2 A physical filing system archive for backup purposes, following data security
best practices will also be maintained in the PV/RA office.
5.2.2.3 The electronic archive will be tamper-proof and allow for audit trails.
5.2.2.4 The archiving system will be indexed to facilitate efficient retrieval based on
various criteria (e.g., product, date, reporter).

Prepared By Checked By Approved By

Signature
Date
Designatio RA Officer QPPV QA Pharmacist
n
Departmen Regulatory Affairs Regulatory Affairs Quality Assurance
t
Format No.: COS/QAD/001/F01-01
 STANDARD OPERATING PROCEDURE

Title: Procedure for Archiving and Retrieval of SOP No. COS/PV/013

Individual Case Safety Reports (ICSRs)
Revision No. 00 Supersedes N/A
Department Regulatory Affairs Page No. Page 4 of 7
Effective Date Review Date

5.2.3 Retrieval Procedures

5.2.3.1 Authorized personnel within Cospharm Pharmaceuticals i.e. the QPPV,
deputy QPPV or their chosen designate will have access to the ICSR archive
system for legitimate purposes related to pharmacovigilance activities.
5.2.3.2 These purposes may include:
 Signal detection and risk analysis.
 Responding to regulatory inquiries.
 Preparing periodic safety reports.
 Pharmacovigilance audits and inspections.

5.2.4 Retention Periods

5.2.4.1 ICSRs will be archived for a period of at least 5 years after the marketing
authorization expiry date of the medicinal product.
5.2.4.2 Cospharm Pharmaceuticals may choose to retain ICSRs for a longer period as
deemed necessary for future pharmacovigilance activities.
5.2.5 Training
5.2.5.1 It is the responsibility of the QPPV, in conjunction with the QA
pharmacist, to ensure that personnel involved in receiving,
processing, archiving, and retrieving ICSRs will receive training on
this SOP and relevant regulations.
5.2.5.2 The training will cover topics such as ICSR identification, data entry
procedures, archiving practices, and retrieval methods.
5.2.5.3 A record of staff trained in all departments shall be kept by the QA
and QMS pharmacist.

5.2.6 Auditing
5.2.6.1 Internal in-house auditing will be organized by the QA and QMS
pharmacist as per self-audit SOP to audit the reconciliation process.
5.2.6.2 Findings from the Audit will be kept on record and used for inhouse
PV system improvement.

6.0 ANNEXURE:

Prepared By Checked By Approved By

Signature
Date
Designatio RA Officer QPPV QA Pharmacist
n
Departmen Regulatory Affairs Regulatory Affairs Quality Assurance
t
Format No.: COS/QAD/001/F01-01
 STANDARD OPERATING PROCEDURE

Title: Procedure for Archiving and Retrieval of SOP No. COS/PV/013

Individual Case Safety Reports (ICSRs)
Revision No. 00 Supersedes N/A
Department Regulatory Affairs Page No. Page 5 of 7
Effective Date Review Date

Annexure No. Title of Annexure Format No.

Annexure 1 ICSR Unique Identifier Allocation Logbook COS/PV/013/F01

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
SAER : Serious Adverse Event Reaction
AE : Adverse Event
ADR : Adverse Drug Reactions

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 03 Controlled Copy
4. General Manager Seasons 04 Controlled Copy
5. General Manager Cospharm 05 Controlled Copy

10.0 CROSS REFERENCE SOP (S):

Prepared By Checked By Approved By
Signature
Date
Designatio RA Officer QPPV QA Pharmacist
n
Departmen Regulatory Affairs Regulatory Affairs Quality Assurance
t
Format No.: COS/QAD/001/F01-01
 STANDARD OPERATING PROCEDURE

Title: Procedure for Archiving and Retrieval of SOP No. COS/PV/013

Individual Case Safety Reports (ICSRs)
Revision No. 00 Supersedes N/A
Department Regulatory Affairs Page No. Page 6 of 7
Effective Date Review Date

 None

11.0 CHANGE HISTORY:

Revision Effective Change Reason for

Details of revision
No. Date Control No. revision

000 None New N/A N/A

12.0 REFERENCES:

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

PHARMACEUTICAL INDUSTRY
 ICH Topic E2D: Post Approval Safety Data Management: Definitions and Standards
for Expedited Reporting
 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).

Prepared By Checked By Approved By

Signature
Date
Designatio RA Officer QPPV QA Pharmacist
n
Departmen Regulatory Affairs Regulatory Affairs Quality Assurance
t
Format No.: COS/QAD/001/F01-01
 STANDARD OPERATING PROCEDURE

Title: Procedure for Archiving and Retrieval of SOP No. COS/PV/013

Individual Case Safety Reports (ICSRs)
Revision No. 00 Supersedes N/A
Department Regulatory Affairs Page No. Page 7 of 7
Effective Date Review Date

 Annexure I: ICSR Unique Identifier Allocation Logbook

Sr. No Unique Date Received Source Brief Comments

Identifier Date the ICSR Who reported Description
Sequential The unique was received by the adverse Any
numbering alphanumeric Cospharm event (e.g., summary of additional
format code Pharmaceuticals. healthcare the reported information
assigned to professional, adverse or notes
the ICSR for patient, event related to
tracking consumer, (optional). the ICSR
purposes. regulatory (optional).
authority).

Format.: COS/PV/013/F01-00

Prepared By Checked By Approved By

Signature
Date
Designatio RA Officer QPPV QA Pharmacist
n
Departmen Regulatory Affairs Regulatory Affairs Quality Assurance
t
Format No.: COS/QAD/001/F01-01