Title: Recall Follow-Up Procedure Issuing Date 1/10/2018

Doc No: STO/07/Rev01 Effective Date

Next Review
Department Drug Inspection & Control Date
Section GSDP Inspection Page 1 of 5

1.0 Purpose

The purpose of this procedure is to illustrate the role of inspection department when a recall is initiated to
protect the public from a defective or potentially harmful product. 

2.0 Scope
1) This procedure applies by drug inspection and control department to assure effectiveness of recall
process.
2) Notifying health professionals, media and the general public when required

3.0 Responsibility

1 Head of drug control - Oversee the recall process and report recall performance to management
and inspection

2 Section Head - Make all necessary arrangement to assure smoothness of recall process

3 Inspector - Keep close contact with related entity and report progress of the recall
process

4.0 Related Documents

- Not Applicable
5.0 References
- Pharmacovigilance Instructions of 2016.
- Drug and Pharmacy Law No.12 of 2013
- Public Health Law No.47 of 2008
- Narcotic Drugs and Psychotropic Substances Law No.23 of 2016
- Instructions for Testing Drugs, Medical Devices and Sterilizers of 2017
6.0 Definitions & Abbreviations
- Recall: the retrieval of pharmaceutical product from the marketplace of a batch or
batches of any medicinal product, which is/are the subject of a quality defect and may
be harmful.

Prepared by Checked by Reviewed by Approved by

Quality Section Head Section Head Dept. Head

Drug Director
 Title: Recall Follow-Up Procedure Issuing Date 1/10/2018
Doc No: STO/07/Rev01 Effective Date
Next Review
Department Drug Inspection & Control Date
Section GSDP Inspection Page 2 of 5

7.0 Procedure
7.1 General
7.1.1 Products recalls are conducted for seriously defective products that pose
health risks to patients by voluntarily by manufacturers or by mandate of
regulatory authorities
7.1.2 The follow-up action consists of a check on the effectiveness of the recall,
investigation of the reason for the recall and remedial action taken to prevent
a recurrence of the defect.
7.1.3 Depending on the nature and expected consequences head of drug inspection
and control department may request an announcement of the drug recall in
local media.
7.1.4 The follow up action consists of evaluation recall effectiveness and
investigation of reason along with corrective actions taken to prevent a
recurrence
7.1.5 JFDA evaluates the effectiveness of a recall by evaluating a company’s
efforts to properly notify customers and remove the defective product from
the market. If a recall is determined to be ineffective JFDA will request the
company take additional actions
7.2 Recall Follow-Up
7.2.1 Head of drug inspection and control departments shall receive the Director
General's decision to recall a drug from markets or a report from drug control
lab indicating failure of product in lab tests.
7.2.2 Head of GMP/GSDP Section shall:
- Contact the local manufacturer and/or warehouse to make all necessary
arrangement for recall process, indicating their role in recall and the
expected time line.
- Assign the inspector to follow up the recall process with relevant entities
to fulfill their role in the recall process.
- Contact stakeholders (by phone, fax, official letters, and email) with the
drug recall and indicate their role in the process, the notification should
be distributed to the following:

Prepared by Checked by Reviewed by Approved by

Quality Section Head Section Head Dept. Head

Drug Director
 Title: Recall Follow-Up Procedure Issuing Date 1/10/2018
Doc No: STO/07/Rev01 Effective Date
Next Review
Department Drug Inspection & Control Date
Section GSDP Inspection Page 3 of 5

1 The Pharmacist Association

2 Jordan Medical Association
3 Royal Medical Services
4 Purchasing and Supply departments at the Ministry of Health
5 Departments of Health in the governorates and districts
6 King Abdullah University Hospital.
7 Any other local entity identified and could be affected by the product

7.2.3 Inspector shall submit a report indicating any observations to the section
head. Who in turn will make any necessary recommendations
7.2.4 Head of drug inspection and control departments shall notify the local
manufacturer or warehouse to make a decision regarding recalled product
such as: destruction, re-export, or any other suitable action.

Prepared by Checked by Reviewed by Approved by

Quality Section Head Section Head Dept. Head

Drug Director
 Title: Recall Follow-Up Procedure Issuing Date 1/10/2018
Doc No: STO/07/Rev01 Effective Date
Next Review
Department Drug Inspection & Control Date
Section GSDP Inspection Page 4 of 5

8.0 Amendment Record

This procedure reviewed to ensure its continuing relevance to the systems and process that it
describes. A record of contextual additions or omissions is given below:

Page No. Context Revision Date

Prepared by Checked by Reviewed by Approved by

Quality Section Head Section Head Dept. Head

Drug Director
 Title: Recall Follow-Up Procedure Issuing Date 1/10/2018
Doc No: STO/07/Rev01 Effective Date
Next Review
Department Drug Inspection & Control Date
Section GSDP Inspection Page 5 of 5

9.0 Process Map

Prepared by Checked by Reviewed by Approved by

Quality Section Head Section Head Dept. Head

Drug Director