Product Recall SOP

SOP for product recall | Standard operating procedure handling of product recall | Product recall procedure in pharmaceutical |

• SOP for product recall covers below points:
  • Type of Product recall
  • Product recall procedure
  • Recall Strategy
    • Depth of Recall
    • Public Warning
    • Mock Recall

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 :

• Q.A. 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.
• Product Recall Team: Product Recall Team take final decision on product recall.
• Technical Head: Carry out the review of the Complaint Investigation with other documents and after consultation with Q.A. 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:

• Q.A. 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.

• If the product is suspected or proven to be defective based on market complaints, stability Study or assessment of likelihood occurrence of the hazard.
• If directed by the local FDA or by the Health / Regulatory authorities of the country where the product is marketed.
• If advised by the Principal company for which the product is manufactured.

5.2 Product Recall Team : Product recall team consist of following members.

• Director
• Technical Head
• Quality Assurance Head
• Quality Control Head
• Production Head

5.3 The product recall is to be initiated by the Q.A. Head depending on the nature of complaint and investigation.

5.4 Type of Product recall :

• 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. Example;
  • Wrong product (label and contents are different),
  • Wrong strength with serious consequences,
  • Chemical or Microbial contamination,
  • Product mix up,
• Class II: Such recalls are executed for products which are found to be defective or substandard but 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. Example;
  • Mislabeling (Wrong or missing text or figures),
  • Missing or incorrect information (Leaflet/Insert),
  • Chemical/Physical contamination (impurities, cross contamination, particulates),
  • Product mix up,
  • Non-compliance with specification,
  • Insecure closure,
• 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. Example;
  • Faulty packing (Wrong or missing batch details),
  • Faulty closure,
  • Particulate contamination,
  • Missing tablet, capsules, strips and blister,

5.5 Product recall procedure :

• 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.
• 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.
• Q.A. Head will investigate the matter and send the report with other documents to Director for review. Director carry out the review of the Investigation with other documents and after consultation with Q.A. Head take decision to recall the product.
• Management call a meeting of Product recall team to evaluate the risk associated with the complaints.
• After the decision of the product recall, Q. A. 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 Q.A. department log the Product recall circular number.
• 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.
• All goods received from the trade in response to recall are isolated from normal stock, warehoused in a specific allotted space “Recalled Goods” where these are labeled as “recalled goods”.
• 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.
• 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 it’s likely hazard on the human. The information will be shared by the Telephone, fax or by Email which is available.
• The overseas agent / Contract giver shall intimate the Drug Authority of the country or as specified in the agreement / contract.
• 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.
• All the requirements of the countries regulatory authority shall be completed by the manufacturer or the agent / contract giver as specified in the agreement / contract.
• 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.
• 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.
• The progress of the recall is closely monitored by Q.A. 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.
• After receiving the recalled stock, the physical verification and counting is done by Warehouse and Q.A. department and then only the reconciliation of the batch finalized.
• 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.
• The returned stock statement (in case of material return to manufacturer) and destruction certificate of regulatory authorities (in case material not return to manufacturer) shall be submitted to local FDA.
• 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.
• Q.A. Head will complete the Product recall monitoring record (Refer Annexure No. 04) with the remark as the Recall is completed and closed.
• Q.A. Head along with the director takes the necessary corrective measures and conveys them to all department head to prevent the recurrence of such recall.
• Q. A. Officer / Executive prepare the Product recall report (Refer Annexure No. 05), checked by Q.A. 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 Q.A. 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 in a year.

5.10 Recall Strategy : A recall strategy will addresses the following elements regarding the conduct of the recall :

• 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 extended as follows :
  • Consumer or User Level, which may vary with products, including any intermediates wholesale,
  • Retail level,
  • Wholesale level,
• 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:
  • General public warning through the general news media, either national or local as appropriate.
  • Public warning through specialized news media e.g. professional or Trade press or to specific segments of the population such as Physician, Hospitals etc.
  • 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 D : 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
Q.A.	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 SOP REFERENCES

• GMP Guidelines

END OF THE SOP

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ANNEXURES :

Annex. No. 01 Format for Product Recall Register

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Annex. No. 02 Format for Product Recall circular

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Annex. No. 03 Format for Product Withdrawal Details

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Annex. No. 04 Format for Product Recall Monitoring

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Annex. No. 05 Format for Product Recall Report

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Annex. No. 06 Format for Product Recall Flow Chart

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