Standard Operating Procedure

Copy No :

Document Name :Handling with Expired and

Damaged Products Inside the Warehouse

Document # : QC-013
Prepared by
Name:Mr. Ayman Khalefa
Position: Operation Manager
(UCTD)
Signature:
Date:

Version # : 01
Compliance Approval
Name:Dr. Soad Mahmoud
Position:Quality &
Compliance Consultant
Signature:
Date:

Page # 1 of 6

Effective Date: 10 / 02/ 2015

Management Approval
Name:Mr. Victor Azzab
Replace
Position: General Manager
SOP
(UCTD)
dated:
Signature:
-\-\Issue Date:

1- Purpose:
Dealing with damaged & expired / going to be expired products.
Clarify stock rotation principles

2- Scope:
All warehouses in United Company For Trading and Distribution.

3- Responsibilities:
12345-

Warehouse storekeeper
Warehouse workers
Warehouse manager
Purchasing department
Warehouses Departement

4- Definitions:
first expiry/first out (FEFO)
A distribution procedure that ensures that the stock with the earliest expiry date is distributed and/or
used before the stock with a later expiry date from the same item.

5-Materials &equipment: N/A

6-Flow chart /Flow Diagram: N/A
7-Procedure:
7-1 Check the expiry date of the receiving the products
Warehouse keeper must check the expiry dates of the received products and reject the expired or
nearly expired products.
Nearly expired product can be accepted in case of existence of prior agreement between UCTD and
the supplier and the warehouse keeper must inform the warehouse manager before receiving that
product.

Standard Operating Procedure

Copy No :

Document Name :Handling with Expired and

Damaged Products Inside the Warehouse

Document # : QC-013
Prepared by
Name:Mr. Ayman Khalefa
Position: Operation Manager
(UCTD)
Signature:
Date:

Version # : 01
Compliance Approval
Name:Dr. Soad Mahmoud
Position:Quality &
Compliance Consultant
Signature:
Date:

Page # 2 of 6

Effective Date: 10 / 02/ 2015

Management Approval
Name:Mr. Victor Azzab
Replace
Position: General Manager
SOP
(UCTD)
dated:
Signature:
-\-\Issue Date:

7-2 Stock rotation

UCTDas a Distributor of many products relating to many MAHs is responsible to send -any Adverse
Drug Reaction (any unfavorable and unintended sign) received from Healthcare Professional or from
Non-Medical Sources (Patients and other Consumers) - to the relevant MAH in correct and timely
fashion, taking into consideration the following:
1-Every attempt should be made to obtain as much as UCTD can from the following minimum
information that constitutes an individual case:
An identifiable Healthcare Professional reporter
The reporter may be identified by name or initials, address or qualification (e.g. physician,
dentist, pharmacist, nurse). Contact details for a Healthcare Professional should be available
An identifiable Patient;
The Patient may be identified by initials, patient number, dateof birth, age, age group, or sex.
Information should be as complete as possible.

At least one suspected active substance/medicinal product;

At least one suspected adverse reaction
At least one drug of suspected adverse drug reaction

2-When UCTD receives safety report where the invented name of the medicinal product is not
specified but only mention the active substance, and the active substance is included in more than one
pharmaceutical product, UCTD should assume that the report may relate to any of these
pharmaceutical products and must send reports to each of all relevant MAHs.
3-When information is received directly from a Patient/Consumer suggesting that an adverse reaction
may have occurred, UCTD should attempt to obtain the Patient's consent to inform MAH in order to
contact the Healthcare Professional involved for further information.
4- When a Consumer submits medical documentation that supports the occurrence of the adverse
reaction, this should be attached with the report.

Standard Operating Procedure

Copy No :

Document Name :Handling with Expired and

Damaged Products Inside the Warehouse

Document # : QC-013
Prepared by
Name:Mr. Ayman Khalefa
Position: Operation Manager
(UCTD)
Signature:
Date:

Version # : 01
Compliance Approval
Name:Dr. Soad Mahmoud
Position:Quality &
Compliance Consultant
Signature:
Date:

Page # 3 of 6

Effective Date: 10 / 02/ 2015

Management Approval
Name:Mr. Victor Azzab
Replace
Position: General Manager
SOP
(UCTD)
dated:
Signature:
-\-\Issue Date:

5-When UCTD receives medical enquiry(s) from the Egyptian Health Authorities or Health Care
Professional (HCP),UCTD must translate it into English and send it to the MAH on timely manner as
per the PV agreement signed with the MAH.

7-3Reporting Time Frames

The MAH should transmit all ICSRs requiring expedited reporting promptly and not later
than 15 calendar days from receipt. This applies to the initial and follow-up information,
while other reports that do not require expedited reporting should be reported to Egyptian
Pharmacovigilance Center (EPVC) within 90 days.
UCTD must inform the MAH promptly with any adversereactionreceived either from
Healthcare Professional or from patients.

7-4Reporting of Individual Case Safety Reports (ICSRs)

Generally, the post-marketing Individual Case Safety Reports of the suspected adverse reactions
associated with a medicinal product are classified.
a)Solicited Reports:are those obtained from organized data collection schemes.
b)Spontaneous report:are those NOT derived from any organized data collection scheme, they
areunsolicited communication by a healthcare professional or consumer.

7-5Recording of ADR
1-If the MAH has specific format regarding thePharmacovigilancereports,UCTD must fill in these
form(s) all the available information.
2-If the MAH has no specific forms, UCTD must send all the available information relating to the
adverse reaction itself and that relating to the source of thereaction.

Standard Operating Procedure

Copy No :

Document Name :Handling with Expired and

Damaged Products Inside the Warehouse

Document # : QC-013
Prepared by
Name:Mr. Ayman Khalefa
Position: Operation Manager
(UCTD)
Signature:
Date:

Version # : 01
Compliance Approval
Name:Dr. Soad Mahmoud
Position:Quality &
Compliance Consultant
Signature:
Date:

Page # 4 of 6

Effective Date: 10 / 02/ 2015

Management Approval
Name:Mr. Victor Azzab
Replace
Position: General Manager
SOP
(UCTD)
dated:
Signature:
-\-\Issue Date:

8- Reference Document :
Egyptian Guideline onPharmacovigilance for Medicinal Products for Human Use -Guideline for
Marketing Authorization Holders- Version 01 /January 2012

9- Forms / Attachments:
Marketing Authorization Holders

(MAHs) format (if any)

Standard Operating Procedure

Copy No :

Document Name :Handling with Expired and

Damaged Products Inside the Warehouse

Document # : QC-013
Prepared by
Name:Mr. Ayman Khalefa
Position: Operation Manager
(UCTD)
Signature:
Date:

Version # : 01
Compliance Approval
Name:Dr. Soad Mahmoud
Position:Quality &
Compliance Consultant
Signature:
Date:

Page # 5 of 6

Effective Date: 10 / 02/ 2015

Management Approval
Name:Mr. Victor Azzab
Replace
Position: General Manager
SOP
(UCTD)
dated:
Signature:
-\-\Issue Date:

10. History
Effective Date

Version

Change Summary

10/02/2015

01

1st issue