Saturday 14 September 2013

PRODUCT RECALL



I.                   PURPOSE
To describe the procedure for the recall of the marketed products, which are found or suspected of not meeting the quality parameters.
II.                SCOPE
This SOP is applicable to recall the finished product from the market at Unit-V.
III.             RESPONSIBILITY
Head QA
Head Marketing
IV.             ACCOUNTABILITY
Managing Director
V.                PROCEDURE
1.0      Reasons for recall
           1.1        If any degradation, detoriation is observed during the stability study.
           1.2        If instructions are given by FDA or Drug Control Authority of India.
           1.3        A customer complaint, which has been established after investigation.
           1.4        If any major variation in quality is observed.
           1.5        Change in physical parameters like odour ,colour, taste.
           1.6        If any discrepancy is found in the label over coding.
           1.7        Package is damaged during the transit.
2.0          In any of the above cases trace the location of the batch through the distribution record of 
           the product and recall the marketed batch.                 
3.0           If any complaint is received from the market, then the Head QA decides the recall            after consulting the Head-Production, Plant-Head, Corporate QA-Head and getting         approval from the Director as per the Format No.: F01/SOPQA015-00.
4.0      The Head QA immediately informs the Head - Marketing through telephone, telex, 
                        fax, E-mail and asks him to stop the further sales of the batch. The Head Marketing must  give the follow up in a written form.
5.0      If the recall is confined within India, then intimate the drug control authority of India &                 local FDA and send the recall request to all the depot locations through fax / register             letter/courier service /E-mail.
6.0      If the batch to be recalled has been exported, then inform the respective regional director   /country manager through fax/courier/ E-mail and ask him to recall the batch. The   
          director/country manager should inform the regulatory agency of the importing country.
7.0            After receiving the recalled product, Warehouse Head informs the QA.
8.0      QA Head compares the stocks returned from the market with the despatch record and   
           fills the ‘Recalled Product checklist’ as per the Format No.:F02/SOPQA015-00.
  9.0      Update the recalled stock record.
           10.0     Store the recalled product separately
   11.0   Head QA investigates the cause of failure leading to the product recall and recommends the corrective action.
12.0    After the date of destruction is confirmed from the legal authorities, QA Head                                fills the ‘Destruction approval form’ as per the Format No.: F03/SOPQA015-00 ,duly               signed by Head QA, and the destruction must be done in the presence of Head QA,                        Head Warehouse, and Head Production.
13.0        The records of product recall should be filed in QA.
14.0    List of formats
Format No.

Title

F01/SOPQA015-00
Authorization for product recall
F02/SOPQA015-00
Recalled Product Checklist
F03/SOPQA015-00
Destruction approval form

VI.      REVISION SUMMARY
Version No.
Revised on

Reason for Revision

00
NA

NA

 

END OF THE DOCUMENT

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