Follow
Purpose: To ensure recall of products that are known or suspected to be defective or hazardous in accordance with a pre-determined plan promptly and effectively from the market.
Scope: This SOP is applicable for all products marketed by (Company Name).
Definitions:
Product Recall: All complaints and other information concerning potentially defective products must be reviewed carefully according to written procedures. A system should be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market.
Responsibilies:
=>> Head of Quality Operation is responsible for determining the intensity of recall to be taken by consultation with Head of factory operations for analyzing the recalled product and also for retaining final recall report with accompanying documentation for future reference.
=>> Head of Factory operation is responsible for taking necessary action and communicates with Managing Director regarding recall issue.
=>> Managing Director is responsible for taking decision regarding recall and the process through which the product will be recalled, nominating recall Coordinator and informing about the mode of disposition to the recall coordinator.
=>> Head of Marketing is responsible for sharing instructions with the marketing peoples about any recall issue.
=>> Recall Coordinator is responsible for handling all aspects of the recall with the appropriate degree of urgency and take all necessary actions in consultation with the Head of Marketing and also for preparing a recall report.
=>> Depot In-charges are responsible for storage recalled products in secured area until disposal of recalled products and for final disposal of recalled products and for informing recall progress to coordinator.
Procedure:
=>> Products with known defects or suspected to be defective shall be recalled from the market.
=>> Below are some defects that could result in a recall:
– Does not meet specification
– Partially effective or non-effective for intended use
– Contaminated or decomposed
– Non sterile or pyrogenic
– Mislabeled or misbranded
– Authentic publication showing negative information on safety or efficacy of the drug
– Sub potent or super potent
– Faulty container
– Govt. Regulations not satisfied
– New Govt. Order
– Reported serious adverse effect of drugs
=>> Determine the intensity of the recall to be taken based on the degree of danger involved in further use of the batch prior to consulting with Managing Director.
=>> Take decision regarding recall and the process of recall whether it would be through ‘Internal Circular’ or through ‘Mass Media’ and mode of recall from international market.
=>> Nominate a person responsible for the execution and coordination of recalls embodied with sufficient staff on adhoc basis to handle all aspects of the recalls with the appropriate degree of urgency.
=>> Assess whether products identified for recall from the market are already distributed in the international market; share the photocopy of this instruction with the overseas agent.
=>> Follow the decision taken, as described in step 5 and inform depots In-charges and field force accordingly
=>> Follow the decision taken, as described in step 5 and inform immediately the concerned person of overseas operation where the products are distributed prior to consultation with Head of International Marketing.
=>> Collect records of distribution from Distribution.
=>> Inform the depot to arrange recalled batch of product from the distributed area.
=>> Store recalled products at the nearest company depot with “RECALLED PRODUCT” label on each outer carton under secured condition.
=>> Inform the progress of the recall every day to the recall coordinator through fax/courier/guaranteed express mail/phone etc.
=>> Compile and reconcile every day’s report and notify to the Managing Director.
=>> Transfer all the recalled products to the central distribution centre (CDC).
=>> Store the recalled product in secured area inside CDC with “RECALLED PRODUCT” label.
=>> Transfer the product to factory.
=>> Inform Head of Quality Operations about recalled product for necessary action.
=>> If the product is toll manufactured form a joint team to investigate the cause .
=>> Perform the necessary test of the recalled product immediately after receiving the sample in factory.
=>> Inform the test results with recommendation for disposition to the Managing Director.
=>> Inform the mode of disposition as per recommendation of Head of Quality Operations to Recall Coordinator.
=>> Share the decision of Managing Director with Head of Factory Operations.
=>> Dispose the product as soon as possible after getting approval from Managing Director.
=>> Prepare a report after completion of the recall process detailing all aspects of the recall including reconciliation, evaluation of the effectiveness of the recall and attached copies of all minutes of the meetings, repairs and correspondence related to the recall.
=>> Send a copy of the final report and accompanying documentation to the Head of Quality Operations for future reference & archival
