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    Standard Operating Procedure For Product Recall

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    RainMan75
    This document outlines the standard operating procedure for conducting a product recall at a pharmaceutical company. It defines the roles and responsibilities of key departments in the recall process. The procedure describes assessing the seriousness of the health hazard, notifying regulatory authorities and internal stakeholders, stopping sales and distribution, retrieving products, documenting activities, and generating a final summary report. Recalls are classified based on their potential health risk and must follow specific notification and response protocols.

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    Standard Operating Procedure For Product Recall

    Uploaded by

    RainMan75
    313 views5 pages
    This document outlines the standard operating procedure for conducting a product recall at a pharmaceutical company. It defines the roles and responsibilities of key departments in the recall process. The procedure describes assessing the seriousness of the health hazard, notifying regulatory authorities and internal stakeholders, stopping sales and distribution, retrieving products, documenting activities, and generating a final summary report. Recalls are classified based on their potential health risk and must follow specific notification and response protocols.

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    Standard Operating Procedure For Product Recall

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    This document outlines the standard operating procedure for conducting a product recall at a pharmaceutical company. It defines the roles and responsibilities of key departments in the recall process. The procedure describes assessing the seriousness of the health hazard, notifying regulatory authorities and internal stakeholders, stopping sales and distribution, retrieving products, documenting activities, and generating a final summary report. Recalls are classified based on their potential health risk and must follow specific notification and response protocols.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    313 views5 pages

    Standard Operating Procedure For Product Recall

    Uploaded by

    RainMan75
    This document outlines the standard operating procedure for conducting a product recall at a pharmaceutical company. It defines the roles and responsibilities of key departments in the recall process. The procedure describes assessing the seriousness of the health hazard, notifying regulatory authorities and internal stakeholders, stopping sales and distribution, retrieving products, documenting activities, and generating a final summary report. Recalls are classified based on their potential health risk and must follow specific notification and response protocols.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 5

    Standard Operating Procedure For Product Recall

    1.0 OBJECTIVE

    1.1 To lay down a procedure for the handling of a product recall of the drug products.

    2.0 SCOPE

    2.1 This procedure is applicable to the recall of any drug product manufactured and
    distributed by …………………..company.

    3.0 RESPONSIBILITY

    3.1 Plant Head for making the decision that a recall is necessary based on appropriate
    input from Regulatory Affairs and Quality Assurance.

    3.2 Head - Quality Assurance for overall coordination of Product Recall.

    3.3 Head - Distribution for issuance of recall notice to all stockiest / Carry and Forward
    (C& F) agents and retrieval of the stocks.

    3.4 Head - Marketing for the retrieval of recalled products.

    3.5 Plant- Head is responsible for the implementation/compliance of this procedure.

    4.0 ACCOUNTABILITY

    4.1 Head-QA/his designee

    5.0 PROCEDURE

    5.1 Recall: Recall refers to the removal of the specific batch (es) of the product from the
    market.
    5.1.1 The recall of batch (es) of the product, including physician samples shall be carried
    in a case:

    5.1.2 Evidence is received/established that a product causes health hazards or may cause
    potential health hazards.

    5.1.3 Deterioration in quality, safety, identity, and purity of the drug product identified
    during product reviews, stability, and market complaint

    5.1.4 Directives from the regulatory authority for recall.

    5.2 Ascertain the seriousness of health hazards caused by the product and its
    consequences. The seriousness shall be classified as:
    5.2.1 Class I defect: Class I is a situation in which there is a reasonable probability that
    the use of or exposure to, a violative product will cause serious adverse health
    consequences or death. This class of defect requires an urgent recall.

    5.2.2 Class II defect: Class II is a situation in which the use of, or exposure to, a violative
    product may cause temporary or medically reversible adverse health consequences or
    where the probability of serious adverse health consequences is remote.

    5.2.3 Class III defect: Class III is a situation in which the use of, or exposure to, a
    violative product is not likely to cause adverse health consequences.

    5.3 Recall submission

    5.3.1 As soon as the information received from customer /regulatory authorities a


    decision is made to voluntarily recall a product, Head QA shall notify the respective
    Regulatory Authorities and shall make a recall submission.

    5.3.2 The recall submission shall include the following information.

    5.3.2.1 Product Information like product name (including generic name), dosage form,
    strength, route of administration, intended use or indications, storage, direction for use,
    and registration number (NDA/ANDA/Drug registration number).

    5.3.2.2 Production identification number, which includes the Batch number,


    Manufacturing date, and Expiry date.

    5.3.2.3 Reason for Recall, information regarding any complaint associated with recall
    received earlier, details of the investigation, and action to prevent the same in future.

    5.3.2.4 Health hazard assessment.

    5.3.2.5 Volume of the recalled product, total quantity produced, distribution details,
    quantity on HOLD at various distribution centers, storage condition of the product
    estimated amount of product remaining in the marketplace.

    5.3.2.6 Distribution pattern, which includes the name and address of the distributors/C&F
    agents.

    5.3.2.7 Recall strategy, which includes the method of notification and method of recall.

    Note: It is not necessary to wait to submit the complete information until all applicable
    information is prepared and assembled.

    5.4 Recall Initiation

    5.4.1 Head QA shall issue the notification to Head-Marketing / Distribution for stoppage
    of sales and distribution as detailed in the format given in Annexure 1.

    5.5 On receipt of notification from Head–QA,


    5.5.1 Head–Marketing shall immediately inform by Telephone / Fax/e-mail to all
    Regional Managers/Country Managers to discontinue further sale/ distribution of the
    batch (es) of the product.

    5.5.2 Manager -Distribution shall immediately inform by Telephone / Fax/email to


    relevant Carry and Forward agents (C&F agents) / Stockist to discontinue further sale/
    distribution of the batch (es) of the product.

    5.5.3 If the defect is Class I, i.e. the situation where the product may pose a significant
    health hazard and recalled product is in the hands of consumers, Head-Marketing or
    designee shall issue a press release/television advertisement promptly.

    5.6 Head QA shall issue the Recall Notification Letter to Head-Marketing / Manager –
    Distribution through e-mail / Fax / Courier or any other fastest mode as detailed in
    Annexure 2 and a copy of the same shall be sent to the regulatory authorities through
    Regulatory Affairs department.

    5.7 The Recall Notification on the Letter shall be flagged in large bold print with
    “URGENT RECALL”.

    5.8 The Recall Notification Letter shall include product identification, description of the
    problem, depth of recall, and appropriate instructions to customers. The
    comments/suggestions from regulatory authorities shall be taken into consideration while
    issuing the Recall Notification letter.

    5.9 On receipt of written notification in format (Annexure 2) from Head-QA, Head-


    Marketing shall immediately inform through written recall notification as per annexure 3
    to all Regional Managers/Distribution Managers/Country Managers to retrieve the batch
    (es) of the product.

    5.10 On receipt of notification, Manager-Distribution shall immediately inform through


    written recall notification as per annexure 4 to all C&F agents and stockists to retrieve the
    batch (es) of the product.

    5.11 All unsold stocks including physicians samples of the batch (es), which are not yet
    dispatched from the depot / Warehouse, shall be retrieved by the concerned
    depot/warehouse in-charges.

    5.12 The Distribution Manager shall reconcile the total batch quantity received dispatches
    made to various locations and shall send a report to the Heads of the Quality Assurance,
    Marketing, and purchase departments.

    5.13 The recalled batch (es) of the product shall be identified and stored separately in the
    secured and segregated area in the warehouse till the final disposition decision of the
    batch (es) is taken.

    5.14 A detailed investigation shall be carried out in coordination with production, QC,
    and QA, and an action plan shall be made to prevent recurrence/correction if any.
    5.15 On retrieval of the batch (es), Head-QA should decide about the disposal of recalled
    batch (es) of the product. If the recalled batch (es) of the product is to be destroyed, it
    shall be carried out as per approved procedures.

    5.16 On completion of all the activity for a recalled product, Head-Quality Assurance,
    shall prepare a summary report (Annexure 5) and shall inform the regulatory authorities
    through the Regulatory Affairs department about the recall details and disposition of the
    same.

    5.17 All activities and actions including the progress of recall shall be documented and
    duly authorized by Head-QA

    5.18 Summary report shall include the following:

    5.18.1 Name of the drug product.

    5.18.2 Batch Number.

    5.18.3 Recall circular No. and date

    5.18.4 Product reconciliation (at different levels from manufacturing through


    distribution).

    5.18.5 Feedback from depots, distributors, retailers, wholesalers, and customers.

    5.18.6 Action is taken for returned goods.

    5.18.7 Reason for recall/withdrawal of drug product.

    5.18.8 Corrective action to prevent recalls.

    5.18.9 Total cost incurred due to recall.

    5.18.10 Effectiveness of recall.

    5.19 The Summary report shall be circulated to all concerned departments and higher
    management.

    6.0 ABBREVIATIONS

    6.1 SOP - Standard Operating Procedure

    6.2 No - Number

    6.3 QA - Quality Assurance

    6.5 QC - Quality Control

    6.6 R&D - Research and Development


    6.7 NDA - New Drug Application

    6.8 ANDA - Abbreviated New Drug Application

    6.9 C&F - Carry and Forward

    7.0 REFERENCES

    7.1 Nil

    8.0 ANNEXURES

    8.1 Annexure: 1 - Format for Stoppage of Sales and Distribution

    8.2 Annexure: 2 - Format for Product Recall Notification

    (from Head QA)

    8.3 Annexure: 3 - Format for Product Recall Notification

    (from Head Marketing)

    8.4 Annexure: 4 - Format for Product Recall Notification

    (from Distribution)

    8.5 Annexure: 5 - Format for Summary of Product Recall

                                                      END OF THE DOCUMENT

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