STANDARD OPERATING PROCEDURE FOR PRODUCT RECALL

1. OBJECTIVE:

  To lay down the procedure for Product Recall.

•    SCOPE:

This procedure applies to products manufactured and packed , already placed on the market, that are subsequently deemed, for whatever reason, to be unfit for their intended purpose  and hence to be recalled.

•    RESPONSIBILITY: 

Head Quality is responsible for carrying out the necessary investigations and inform representative for due course of action for product recall.

Head – Operations is authorized to approve the Product Recall.

•    PROCEDURE:
  •          PREAMBLE :
    •    The product recall is considered as a matter of urgency and implemented without delay.
  •          Product recall is considered under the following circumstances.
    • Mislabeling of the product.
    • Mix-ups of different products.
    • Contamination and adulteration, which may cause serious health hazards.
    • Recall ordered by any regulatory agencies due to any specific reasons.
    • Recall necessitated due to Product not conforming to the Quality Attributes.
  •          Information regarding products that may be deemed unfit for their intended purpose, may be received from:
    • The customers.
    • The Regulatory Authority.
    • Quality issues related to counterfeit incidents, product tampering incidents.
    • Quality issues confirmed related to stability failures and product reviews significant.
    • Observations / variations noticed.
    • Supplier’s incidents leading to product or facility.
  • Information on defective products are usually received by:
    • Marketing department of Parent Companies – from customers.
    • Quality Assurance – from Regulatory & Statutory authorities.
    • In case the intimation is received by QA directly, shall immediately inform marketing department/Parent company.
  •           On receipt of information regarding a product defect, the information is immediately sent to Head-Quality.
  •           Quality Assurance collects the following information:
    • Name address and telephone number of the complainant.
    • Name, batch number, quantity and expiry date of the defective product.
    • Details regarding the nature of the defect and whether any adverse effects have occurred that may be at attributable to the defect in the product.
    • The quantity distributed – customer wise.
  • Evaluation of the information: Head- Quality evaluates the information & initiate investigation in to the complaint ‘Market Complaints’ comprising of:
    • Re-evaluation & retesting of the retained sample and / or complainant sample, if received.
    • Review of the BPR and Testing & Release Documents.
    • Send, if required, QA executive to the complainant to ascertain the facts.
  • Initiation of the Recall: Based on the outcome of investigation, Head Quality recommends, product recall (if necessary) to Head – Operations.
  • Information about the Recall:
    • After obtaining the approval, Head Quality informs Marketing & Commercial Departments/Parent Company about the recommendation to recall the Product. The ultimate decision for Recall of the Product will be given by Parent Company in writing.
    • After receiving the approval  from Parent Company ,Head Quality immediately advise commercial department to hold further distribution, and / or sale, of that product pertaining to that specific batch (s) nos.  QA draws a timeframe for recalling the Product in consultation with marketing & commercial department/parent company.
    •    In the situation resulting in the Product Recall, Regulatory Authorities wherever appropriate, depending upon the reasons of recall is also informed.  In the event of a serious or potentially life threatening situation Local, National and / or International authorities are also informed of the recall. This communication will be drafted in consultation with the Parent Company.
  •           Reconciliation of the Recalled Product: Commercial department reconciles the quantity of the recalled product against the quantity dispatched.  This is verified by QA.  The reconciliation record is also maintained by QA.
    •    The recalled product is kept under quarantine, until the recall is completed.
  • Disposition of the Recalled Product:
    •    QA carries out detailed investigation on the Recalled Product to ascertain the reasons as per SOP and submit the Report to Head Quality who in turn informs to Head- Operations.
    •    After completion of the investigation the decision to destroy or reprocess of the recalled product is taken in consultation with the Head Operations and Parent Company
    •    In the event of a recall being affected by virtue of a directive from the Drug Regulatory Agency / authority, an approval for appropriate disposal / destruction on stocks recalled is sought and obtained from the Drug Regulatory Agency / Authority.
    •    In case the product can be reprocessed the approval for reprocessing of stocks recalled is sought and obtained from the Drug Regulatory Agency / Authority and then only the reprocessing is undertaken.
    •    The Re-labeling, Re-work, Re-processing or Disposal of the Recalled Product is carried out and monitored by QA.
  • Handling of the Recalled Products:

SR. No.	Reason for recall	Handling methods
1.	Mislabeling of the Product / Mix-up/ Contamination and adulteration	Destroy the material under supervision of QA personnel and document the details.
2.	Regulatory  order	Destroy or reprocess the material under supervision of QA and concerned regulatory body personnel and document the details.
3	Product not conforming to Quality Attributes – specifications.	Destroy or reprocess the material under supervision of QA, take approval from statutory bodies, wherever required and document the details.
4	Product not conforming to Quality Attributes – packaging.	Destroy / re label or reprocess the material under supervision of QA, take approval from statutory bodies, wherever required and document the details.

              The investigation reports and CAPA’s are documented and are captured in the Annual product review (APR)

•   FORMATS & ANNEXURES:

SR.No.	FORMAT NO.	TITLE OF THE FORMAT
1	NA	Product Recall Authorization
2	NA	Recalled Product Reconciliation Disposition record

•   RECORDS:

SR.No.	TITLE OF THE RECORD	TYPE
1	Product Recall Authorization	File
2	Recalled Product Reconciliation Disposition record	File

•   FREQUENCY: 

               As when required.

•  ABBREVATIONS:

 BPR        –      Batch Packing Record

CAPA    –       Corrective & Preventive Action

QA      –       Quality Assurance                  

SOP    –       Standard Operating Procedure

•    ATTACHMENTS / REFERENCES :
• NA

1.   REVISION HISTORY:

Revision No.	Effective Date	Reason for Revision
NA	NA	NA