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SOP for Product Recall | Standard operating procedure handling

SOP for product recall covers below points:

1.0 OBJECTIVE
To describe a procedure for Product Recall.

2.0 SCOPE
This procedure is applicable to recall of dispatched products, if suspected or detected
defective.

3.0 RESPONSIBILITY
l QA Head: To initiate the recall after the final decision given by Product recall team for
product recall, monitor the product recall and close the product recall.
l Product Recall Team: Product Recall Team take final decision on product recall.
l Technical Head: Carry out the review of the Complaint Investigation with other
documents and after consultation with QA Head makes the recommendations to the
higher management for the recall of the product in case the investigation indicates that
the particular batch of the product is not of standard quality and complaint is genuine.

4.0 ACCOUNTABILITY
QA Head
5.0 PROCEDURE
Recall: Recall refers to the removal/return of specific batch/batches of the product.
Withdrawal: Withdrawal implies total removal of product from the market.
5.1 A recall of marketed product will be instituted in following conditions.
l If the product is suspected or proven to be defective based on market complaints,
stability Study or assessment of likelihood occurrence of the hazard.
l If directed by the local FDA or by the Health/Regulatory authorities of the country
where the product is marketed.
l If advised by the principal company for which the product is manufactured.
5.2 Product Recall Team: Product recall team consists of following members;
l Director
l Technical Head
l Quality Assurance Head
l Quality Control Head
l Production Head
5.3 The product recall is to be initiated by the QA Head depending on the nature of complaint
and investigation.
5.4 Type of product recall:
l Class I: This is for dangerous or defective product that causes serious consequences to
health including death. The decision to make an urgent recall will be taken by the
product recall team based on the investigation findings of the market complaints, or as
recommendation by medical advisor or as per the advice of Principal company or as per
internal information (voluntary recall). The recall is initiated within 3 working days from
the recommendation of Product Recall Team. For example;
o Wrong product (label and contents are different),
o Wrong strength with serious consequences,
o Chemical or microbial contamination,
o Product mix up.
l Class II: Such recalls are executed for products which are found to be defective or
substandard but do not pose a health risk or might cause a temporary health problem.
The recall is initiated within 7 working days from the recommendation of product recall
team. For example;
o Mislabeling (Wrong or missing text or figures),
 o Missing or incorrect information (Leaflet/Insert),
o Chemical/Physical contamination (impurities, cross contamination, particulates),
o Product mix up,
o Non-compliance with specification,
o Insecure closure.
l Class III: These recalls are for the products that are unlikely to cause any adverse effect
to the health but not able to match the FDA labeling or manufacturing regulations as per
GMP. For example;
o Faulty packing (Wrong or missing batch details),
o Faulty closure,
o Particulate contamination,
o Missing tablet, capsules, strips and blister.
5.5 Product recall procedure:
l For any recall, intimation is given to the warehouse department, distribution
department and directors of company to recall the product within a specified period of
time.
l The warehouse department/distribution department on receipt of action report shall
initiate the recall procedure to the concerned distributors and stockist’s by mail, courier
and telephone for asking them to stop sales of product and withdraw the batch from
the market. Details of distribution of batch with quantity and parties name and address
shall be submitted to Quality Assurance Head.
l QA Head will investigate the matter and send the report with other documents to the
Director for review. Director carries out the review of the Investigation with other
documents and after consultation with QA Head take decision to recall the product.
l Management calls a meeting of Product Recall Team to evaluate the risk associated with
the complaints.
l After the decision of the product recall, QA Head initiates the product recall along with
the director and takes the necessary entry of the recall in the Product Recall Register
(Refer Annexure No. 01). Officer/Executive of QA Department log the Product recall
circular number.
l Product recall number will be assigned as;
PRC/XX/YYY
Where;
PRC: stands for Product Recall Circular,
 XX: Last two digits of the Calendar Year, and
YYY: Serial number of product recall circular.
l All goods received from the trade in response to recall are isolated from normal stock,
warehoused in a specific allotted space where these are labeled as “Recalled Goods”.
l In case of Loan License, the recall decision is taken by Principal company. All the recalls
shall be communicated to the local regulatory authorities with the recall schedule.
l Director/Marketing Head will send a product recall circular (Refer Annexure No. 02) to
the Overseas agent/contract giver, where the product has been shifted and intimate the
type of recall with the defect in the product and its’ likely hazard on the human. The
information will be shared by the Telephone, fax or by email which is available.
l The overseas agent/contract giver shall intimate the Drug Authority of the country or as
specified in the agreement/contract.
l The agent/contract giver shall be instructed to all the distributor, retailers where he/she
distributed the product about stoppage of the sale of the product and return back the
material at the earliest.
l All the requirements of the country’s regulatory authority shall be completed by the
manufacturer or the agent/contract giver as specified in the agreement/contract.
l After recalling or receiving the material by the agent/contract giver, he/she sends the
product withdrawal details of the batch (Refer Annexure No. 03) to manufacturer.
l The arrangement shall be made to shift the product to India or destroyed in the country
as per the instruction given by the regulatory authority of the country where the
product is exported.
l The progress of the recall is closely monitored by QA Head. The withdrawal details of
the batch (Refer Annexure No. 03) received by the distributor/agent are recorded in the
Product Recall Monitoring (Refer Annexure No. 04) and the reconciliation of the batch is
carried out on the basis of the material distributed and the material recovered from the
market.
l After receiving the recalled stock, the physical verification and counting is done by
Warehouse and QA Department and then only the reconciliation of the batch finalized.
l If the regulatory body of export country do not allow the material to shift to
manufacturer in India and insist the material to destroy in exported country. Then,
official report of the regulatory authority for the product destruction along with the
quantity destroyed in front of representative of the regulatory body and the agent
should be sent to manufacturer.
l The returned stock statement (in case of material return to manufacturer) and
destruction certificate of regulatory authorities (in case material does not return to
manufacturer) shall be submitted to local FDA.
 l The recalled stock of the product shall be kept separately in Recalled Goods Warehouse
under lock and key till the final decision taken from the product recall team.
l QA Head will complete the Product recall monitoring record (Refer Annexure No. 04)
with the remark as the Recall is completed and closed.
l QA Head along with the director takes the necessary corrective measures and conveys
them to all Department Heads to prevent the recurrence of such recall.
l QA Officer/Executive prepare the Product recall report (Refer Annexure No. 05),
checked by QA Head and Approved by Director.
5.6 The recall register is maintained for this purpose; the testing of control samples is initiated
in the required cases.
5.7 After arriving at a final conclusion, the stock is destroyed in the presence of the QA Head.
5.8 For non-occurrence of recall of product, decision is taken about appropriate steps.
5.9 Evaluation of recall incident shall be done once a year.
5.10 Recall Strategy: a recall strategy will addresses the following elements regarding the
conduct of the recall:
l Depth of Recall: Depending upon the products degree of hazards and extent of
distribution, the recall strategy will specify the levels in the distribution chain to which
the recall is to be extended as follows:
o Consumer or User Level, which may vary with products, including any intermediates
wholesale,
o Retail level,
o Wholesale level.
l Public Warning: The purpose of public warning is to alert the public that a product being
recalled presents a serious health Hazards (for Class I type product recall). The recall
strategy will specify whether a public warning is needed and whether it will issue as:
o General public warning through the general news media, either national or local as
appropriate.
o Public warning through specialized news media, e.g., professional or Trade press or
to specific segments of the population such as Physician, Hospitals, etc.
o Mock Recall:
Effectiveness Check: The purpose of the effectiveness checks is to verify that all the
consignees at the recall depth specified by the strategy have received notification
about the recall and have taken the appropriate action. The recall strategy will
specify the method to be used for and the level of effectiveness checks that will be
conducted as follows:
  Level A: 100% of the total number of the consignees to be contacted,
 Level B: Some % of the total number of consignees to be contacted, the
percentage is determined on a case by case basis, but is greater than 10% and
less than 100% of the total number of consignees.
 Level C: 10% of the total number of the consignees to be contacted.
 Level C: 2% of the total number of the consignees to be contacted.
 Level E: Check on effectiveness.

6.0 ABBREVIATIONS
Abbreviation Expanded form
SOP Standard Operating Procedure
QA Quality Assurance
FDA Food and Drug Administration
GMP Good Manufacturing Practices
GEN General
QAD Quality Assurance Department

7.0 ANNEXURES
Annexure No. Title
01 Format for Product Recall Register
02 Format for Product Recall circular
03 Format for Product Withdrawal Details
04 Format for Product Recall Monitoring
05 Format for Product Recall Report
06 Format for Product Recall Flow Chart

8.0 REFERENCES
1. GMP Guidelines
2. SOP…
ANNEXURES:
Annex. No. 01 Format for Product Recall Register
Annex. No. 02 Format for Product Recall circular
Annex. No. 03 Format for Product Withdrawal Details
Annex. No. 04 Format for Product Recall Monitoring
Annex. No. 05 Format for Product Recall Report
Annex. No. 06 Format for Product Recall Flow Chart