STANDARD OPERATING

Document No. 3
PROCEDURE

Revision No. 0
PRODUCT RECALL
Page No. 1 of 4
Prepared by/Date: Approved by/Date:

Issuance No. 1 : Desiree T. Manero, RPh Madeline M. Pajarillo

Effective Date : 01 July 2021

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the
efficient and effective management of product recalls of medical devices to ensure the safety of
patients and compliance with regulatory requirements.
I. OBJECTIVE:
 The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the
efficient and effective management of product recalls of medical devices to ensure the
safety of patients and compliance with regulatory requirements.
II. SCOPE:
 This SOP applies to all personnel involved in the recall process, including the Regulatory
Affairs Officer/Pharmacist, Manufacturer/Supplier, Distributors, Audit and Operations
Officer
III. DEFINITIONS:
3.1 Product Recall : The action of removing or correcting medical devices that have been
found to be in violation of regulatory requirements or pose risk to public health.
3.2 Medical Device : Any instrument, apparatus, implement, machine, appliance, implant,
reagent for in vitro use, software, material, or other similar or related article, intended
by the manufacturer to be used, alone or in combination, for human beings for one or
more of the following purposes: A) Diagnosis, prevention, monitoring, treatment, or
alleviation of disease. B) Diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or disability C) Investigation, replacement, or modification
of the anatomy or of a physiological process.
 STANDARD OPERATING
Document No. 3
PROCEDURE

Revision No. 0
PRODUCT RECALL
Page No. 2 of 4
Prepared by/Date: Approved by/Date:

Issuance No. 1 : Desiree T. Manero, RPh Madeline M. Pajarillo

Effective Date : 01 July 2021

IV. RESPONSIBILITIES
4.1 Audit/Operations Officer: Initiate and coordinate product recalls, maintain records,
and ensure compliance with regulatory authorities.
4.2 Regulatory Affairs Officer/Pharmacist: Interface with regulatory authorities, ensure
proper documentation, and oversee the reporting process.
4.3 Manufacturer/Supplier: Identify the root cause of the issue, initiate corrective actions,
and provide information for the recall strategy.
4.4 Distributor: Assist in the retrieval of recalled products from customers and
communicate with affected parties.

V. PROCEDURE
5.1 Identification of a Potential Recall

5.1.a Any employee who becomes aware of a potential issue with a medical device that
may require recall should immediately report it to the Regulatory Affairs Officer and
Operations Officer.

5.1.b Regulatory Affairs Officer and Operations Officer will assess the issue and, if
necessary, initiate the recall process.

5.2 Initiation of Recall

5.2.a Regulatory Affairs Officer and Operations Officer will prepare a Recall Action
Plan which includes: i. A description of the issue and its potential risks; ii. A detailed
recall strategy, including scope, timing, and communication plan; iii. Assignment of
responsibilities for each phase of the recall process
 STANDARD OPERATING
Document No. 3
PROCEDURE

Revision No. 0
PRODUCT RECALL
Page No. 3 of 4
Prepared by/Date: Approved by/Date:

Issuance No. 1 : Desiree T. Manero, RPh Madeline M. Pajarillo

Effective Date : 01 July 2021

5.3 Execution of Recall

5.3.a Manufacturer will investigate and address the root cause of the issue, and
corrective actions will be implemented to prevent recurrence.

5.3.b Distributor will coordinate the retrieval of recalled products from customers and
maintain records of all returns.

5.4 Communication

5.4.a Affected parties, including customers, regulatory authorities, and distributors,

will be informed in a timely and transparent manner, providing clear instructions on the
recall process.

5.4.b Continuous communication will be maintained throughout the recall process to

update affected parties on the progress.

5.5 Closure of Recall

5.5.a Audit and Operations Officer will evaluate the effectiveness of the recall and
prepare a final report.

5.5.b Regulatory Affairs Officer/Pharmacist will ensure all regulatory reporting

requirements are met.

VI. RECORD KEEPING

 All records related to product recalls, including communications, corrective actions, and
investigative findings, will be maintained in a secure and organized manner in
compliance with regulatory requirements.
 STANDARD OPERATING
Document No. 3
PROCEDURE

Revision No. 0
PRODUCT RECALL
Page No. 4 of 4
Prepared by/Date: Approved by/Date:

Issuance No. 1 : Desiree T. Manero, RPh Madeline M. Pajarillo

Effective Date : 01 July 2021

VII. TRAINING:
 All relevant personnel will receive training on this SOP and any updates to ensure a
clear understanding of their roles and responsibilities in the event of a product recall.

VIII. REVIEW AND REVISION

 This SOP will be reviewed annually and updated as necessary to reflect changes in
regulations, processes, or organizational structure.

IX. FORMS:

Logbook

X. END OF DOCUMENT