Title: STANDARD OPERATING PROCEDURE Document: SOP_QA_ rev.__

PRODUCT RECALL

Effective Date: dd.mm.yyyy.

Page: 1 of 3

Applicable to Departments:

SAL, QA, MA, RE, WH

Table of Contents:

1. Purpose .................................................................................................................................................. 2

2. Scope ...................................................................................................................................................... 2

3. Responsibilities ...................................................................................................................................... 2

4. Definitions and abbreviations ................................................................................................................ 2

5. Procedure ............................................................................................................................................... 3

6. Reviosion Hystory ................................................................................................................................ 5

1. Purpose

This procedure specifies the responsibilities and the system for product recall from the market, as required,

to prevent unacceptable quality products to reach the customers (patients). This SOP also specifies,

pursuant to the Medicines Law, the way of notification of all stakeholders by the relevant departments of

the decision made to recall an already marketed product.

2. Scope

This SOP is applicable to all authorized and marketed products for which there is an evidence or potential

that:

• The product is noncompliant with the Marketing Authorization and, therefore, can have undesirable

effects to the patient’s health.

• The reputation of the Company can be severely compromised.

3. Responsibilities

QA Manager is responsible for the implementation of this SOP.

Other responsibilities are specified by sequence of activities and job descriptions.

4. Definitions

4.1 Distribution network

Distribution route of the product from leaving the Company premises to arrival to different wholesalers,

health centers, and hospital and public pharmacies.

4.2 Product recall

Product recall from the market includes the overall action is undertaking in case of recall of one or several

product batches from the market with the objective to protect the patients from inappropriate product which

could have adverse effects and compromise their health.

4.3 Recall notification

Written information sent to all companies, institutions or individual customers to whom the recalled

product has been supplied.

4.4 Official recall notification

The official notification of product recall to the Ministry of Health shall be made when the product

noncompliance is of the nature that could compromise public health.

5. Procedure

A product is recalled from the market based on:

• Complaint from the market;

Title: STANDARD OPERATING PROCEDURE Document: SOP_QA_ rev.__

PRODUCT RECALL

Effective Date: dd.mm.yyyy.

Page: 2 of 3

Applicable to Departments:

SAL, QA, MA, RE, WH

• Recall order issued by the national inspection authorities;

• Deviation from the specified quality is discovered after the product was distributed on the market;

• Labeling error;

• When the product is denied Marketing Authorization.

5.1 Investigation and Actions

A product can be recalled for the following reasons:

• Mistake in the manufacturing or packaging process, discovered after the product was released on the

market;

• Product testing or release mistakes discovered after the product was released on the market;

• Unacceptable stability test results;

• Frequent customer complaints on the product quality;

• Serious warning of the medicinal product safety obtained after reviewing PSUR – unexpected

undesirable events or a known undesirable event occurring with increased frequency.

When, for any of the above reason, a need is identified for product recall from the market, the team

consisting of the QA Manager, Sales and Regulatory Affairs Managers shall, based on the available

documentation on the product batch in question, assess the emergency and the establish the recall scope.

The team shall specify the strategy to be used for recalling only part or the whole product batch or several

batches (time frame for recall execution, institutions to be notified of the recall, and collecting the product

distribution data). If required, the team shall specify the action to be taken for release of information to

public and define contact with the media to avoid negative publicity. They shall relate to the Finance

Division to identify the resources required for recalling the product and discuss its cost effects.

This decision shall be documented on the form ’Product Recall Decision’

Sales Manager shall coordinate the contact with customers and report recall action progress.

5.2 Identifying distribution sites

The Sales Manager shall, together with the wholesaler’s warehouse, establish the product stock status in the

warehouse and at any site to which the recalled product was distributed, the exact quantities of the product

and supply dates. The Sales associate/administrative officer shall produce the customer list including their

addresses, telephone numbers and contact persons, as well as the supplied quantities and submit it to the

Sales Manager.

5.3 Recall notification

The recall team shall prepare a recall notification in writing on the Company Memorandum.

5.4 Distribution of the recall notification

The QA Manager shall, depending on the assessed emergency, submit the recall notification to the Ministry

of Health, to all listed customers, and/or media (if the reason for recall is of the nature that can compromise

public health).

5.5 Product recall

On the basis of agreed action, the Sales Manager shall, together with the Shipping Department, arrange for

collecting the recalled product from the market. The product from individual customers shall be collected

by the field operators who shall prepare written reports on the product quantity collected from each

customer and make the reconciliation of the supplied and collected quantities.

Title: STANDARD OPERATING PROCEDURE Document: SOP_QA_ rev.__

PRODUCT RECALL

Effective Date: dd.mm.yyyy.

Page: 3 of 3

Applicable to Departments:

SAL, QA, MA, RE, WH

The Sales Manager shall coordinate product recall from the market; monitor the recall action and report of

the recall progress.

5.6 Recalled products storage

The warehouse shall receive the recalled products and keep the records of the arrived quantities.

The collected recalled products shall be stored in a segregated area and appropriately labeled with the

inscription „PRODUCT RECALLED FROM THE MARKET“, where they will be waiting for disposal.

5.7 Recall Final report

The Sales Manager shall, with other team members, prepare the final report on all actions taken for product

recall from the market including the recalled quantity, and submit it to the Top Management.

This Final Report shall also be submitted to the Ministry of Health.

5.8 Recalled product log

Based on the Final Recall Report, the QA Manager shall keep the recalled product log using the form

Recalled Products Log

The recalled products report shall be prepared periodically and distributed to the Top Management.

5.9 Archiving

All relevant documents (Recall Decision, Recall Notification, Product Distribution List, and Field Reports

on Product Recall) shall be kept with the Sales Department for 6 years

Recalled Product Log shall be kept with QA 6 years.

6. Revision History

Revision No. Description of Change

00 Basic document

01 Change of SOP code and minor changes in the text

End of document