Standard Operating Procedure for Product Recall

1. SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL
Standard Operating Procedure for
Product Recall
Document Number: C107
Revision Number: 00
Effective Date: 06/15/14
Author: Muna Ali Date: 05/12/14
Author: Sahar Ansari Date: 05/12/14
Approvals: John Smith Date: 06/15/14
PAGE 1 OF 6

2. SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL
1. Introduction
Product recall is indicated when a product could represent a health risk to the consumer
2. Purpose
To provide a documented procedure of handling of product recall
3. Scope
This procedure is applicable to recall quality defective drugs when reported incidents of safety and efficacy are
received
4. Responsibility
Quality Assurance (QA) will take the overall responsibility for co-ordination of Recall. In the absence of QA, Plant
Manager will assume the responsibility.
5. Attachments
Product Recall Report
6. Procedure
6.1 Initiation of product recall
6.1.1 If there is a market complaints about the product's risk
6.1.2 If manufacturers, wholesalers, retailers and hospital pharmacists reports possible occurrence
of health risk
6.1.3 If the sample failed in analysis tested by National Medicine Laboratories (NML) or by private
testing laboratories
6.1.4 If the health publications shows the risk
6.2 Preliminary recall assessment (gathering and reviewing following document about the product):
6.2.1 Product information
6.2.2 Labels of the product
6.2.3 Distribution pattern
6.2.4 Product complaints
6.2.5 Product specifications
PAGE 2 OF 6

3. SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL
6.2.6 Operations manuals, brochures, flyers, or any other product related literature that will aid in
determining the violation and evaluation of the product problem
6.2.7 Formulation of the product
6.2.8 Analytical report and methods used to obtain the results of the product involved
6.2.9 Process validation protocols and reports
6.2.10 Analytical validation protocols and reports
6.3 Identification of a root cause of a potential product non-compliance issue
6.4 Decide whether to recall the product or not
6.4.1 If recall is not required, response to customer accordingly
6.5 If recall is required, distribution record shall be checked and following information to be sent to Export
department for recall of product
6.5.1 Product(s) name
6.5.2 Batch number
6.5.3 Nature of defect
6.5.4 Date of Manufacturing
6.5.5 Date of Expiry
6.5.6 Exported to
6.5.7 Point of recall
6.5.8 Total quantity to be recall
6.5.9 Shipper carton no. or container no.
6.6 The QA shall ensure that all those, within the company, concerned with the storage, packing and
destruction of products and materials are aware of the problem and action to be taken.
6.7 The QA shall convey following information to concern department
6.7.1 Name of product(s)
6.7.2 Batch number(s)
6.7.3 Nature of defect
PAGE 3 OF 6

4. SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL
6.7.4 Action to be taken
6.8 All affected, or potentially affected, kits and any other stocks or materials shall be securely segregated,
and effectively quarantined so as to be sure they cannot be dispatched.
6.9 The QA shall arrange for prompt preparation of a list of the recipients of the defective product
6.10 According to the urgency/extent of potential risk, direct mailing, telephone call, email or fax shall
convey this information
6.11 If the defect is considered to be too serious to permit any delay, steps must be taken to inform all
potential or possible recipients without necessarily waiting for the collection of full distribution data.
6.12 If defect is considered to represent a serious and immediate risk to user or consumers, then
consideration must be given in consultation with marketing department to the use of the media to provide
wider awareness of the problem.
6.13 When recall has been initiated, arrangements must be made by QA to receive the returned goods, and
to ensure that they are securely segregated from other stock, and stored in specified area.
6.14 The progress of the recall shall be recorded and monitored by QA, so that the quantity of goods
returned can be reconciled against the amount produced, distributed, and still held in stock.
6.15 Timeline of maximum 5 days from class I recall, up to a maximum of 10 days for class II recall and up
to a maximum of 30 days for class III recall shall be permitted
6.16 Communicate/warn public/related professionals and institutions about the health risk of the recalled
product.
6.16.1 In cases of class-I recall, public announcements shall be made to stop the usage of the drug
immediately, using fastest mode of communication such as newspapers, television, radio, and the
internet
6.17 When it is considered that the recall/freeze has been accomplished as completely as possible, a full
report shall be prepared by the QA.
6.18 The detailed report shall contain
6.18.1 Reason for recall/freeze
6.18.2 Results of full investigation into cause(s) of the defective product
6.18.3 Action taken to recall etc.
6.18.4 Numerical details of the reconciliation exercise
PAGE 4 OF 6

5. SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL
6.18.5 Action taken to prevent re-occurrence.
6.18.6 Copy of this report shall be forwarded to Managing Director.
6.19 Monitoring and follow up action must be done to ensure recall action is effective and remedial action
taken to prevent a recurrence of the defect.
6.20 Documentation of findings
6.21 Closure of a Recall
7. Definitions
7.1 Class I: Defects are potentially life threatening or could cause a serious risk to health
7.2 Class II: Defects could cause illness or mistreatment, but are not Class I
7.3 Class III: Defects may not pose a significant hazard to health, but withdrawal may have been initiated for
other reasons
PAGE 5 OF 6

6. SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL
PRODUCT RECALL REPORT
REFERENCE NUMBER
Product Recall Class of
Defect (Choose either
class I, II or III)
I. II. III.
Product Name (Both
Brand and Generic
Name)
Marketing
Authorization Number
Dosage Form
Strength
Batch Number
Expiry Date
Manufacturer Name
and Telephone Number
Recall Number
assigned
Information on
distribution including
exports
Details on Defect/
Reason for Recall
Results of Full
Investigation into
Causes of Defect
Actions Taken to Recall
Actions Taken to
Prevent Re-occurence
Signed
Date
PAGE 6 OF 6