Follow recall process and procedures |
The requirements for the management of recall, including the types of records that should be kept for supply chain traceability, as well as sale and distribution records of wholesale or retail supply, are described in the Health Products (Cell, Tissue and Gene Therapy Products) Regulation.
The PIC/S GMP Guide and/or HSA Guidelines on Good Manufacturing Practice For Cell, Tissue And Gene Therapy Products stipulate the establishment of written procedures which will be implemented as the need for a recall by the manufacturer arises. HSA Guidance Notes on Good Distribution Practice also stipulates the establishment of written recall procedures by the importers and wholesalers of CTGTP.
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Notify stakeholders of recall actions |
Company communicates the presence of defects and the recall actions to be taken to the customers through appropriate means.
A Dear Purchaser Letter is a letter issued by the company to its purchasers (such as hospitals, clinics, retail stores) to alert them to the administrative or logistic matters related to the product recall.
The Dear Purchaser Letter should include (but not limited to) the following information:
- Audience / targeted recipient.
- Purpose of letter.
- Product details (brand name, active ingredient, affected batch number, product image, images to guide where to find the batch details, if needed).
- Description of issue, reason for recall and any potential health hazards.
- Level of recall (wholesale or retail level)
- Instruction to customers e.g. remove product from sale, cease distribution, return product, conduct sub-recall if appropriate.
- Refund mechanism.
- Company’s contact.
- Return response card / form which includes a space for purchaser’s signature and date to acknowledge the recall and that they have followed through the recall instructions.
A Dear Healthcare Professional Letter is issued to notify the healthcare professionals about important new or updated information regarding major safety, quality and efficacy concerns related to the use of a product that presents potential risks to patients or public health. Company can discuss with HSA on the issuance of the Dear Healthcare Professional Letter.
The Dear Healthcare Professional Letter should include (but not limited to) the following information:
- Purpose of letter;
- Product details (brand name, active ingredient, affected batch number, product image, images to guide where to find the batch details if needed).
- Description of the issue, reason for recall and any potential health hazard(s);
- Actions required by patients;
- Advisories for healthcare professionals on clinical management and monitoring of patients if any; and
- Hotline number(s) (and operating hours) whereby healthcare professionals are able to contact the company should they have any additional questions relating to the recall.
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Complete recall |
Company must keep HSA informed of the progress of the recall action. Company should perform an effectiveness check to verify that the recall communication was received by the customers and that they understood and followed through the recall instructions.
Company needs to furnish the Product Recall Completion Form upon completion of the product recall, together with a report of reconciliation of quantities of each affected batch (i.e. delivered and returned quantities).
As part of the recall completion report, company updates HSA of the completion follow-up actions i.e. submit the certificate of destruction to HSA within 3 months from the completion of the recall. Prior approval for local destruction is not required.
If any other actions are to be taken, specify them on the Product Recall Completion Form and they will be subjected to HSA’s approval.
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Reinstatement of supply |
Corrective actions need to be performed to address the quality defect and carry out preventive actions to prevent recurrence of the defect in the future before reinstating supply of product.
Quarantined stocks can only be released with HSA's concurrence, when it has been determined that there is no safety risk in the use of the product or after appropriate corrective actions had been taken to address the safety risk.
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