Pharmaceutical Plant Complaints and Product Recall as Per GMP

Complaints & Recall

Earlier I have shared you the GMP Requirement for Pharmaceutical plant premises, Equipment’s, Production, Training, personnel Hygiene, Self-Inspection, quality audits and suppliers’ audit, Personnel and Quality Control. There are various modules of GMP which I will share one after another & today’s module is Complaints & Recall.

Complaints :

What is Product Complaints:   

Any Manufacturing or Packaging related complaints with respect to a Product, including (a) any complaint involving the possible failure of Product to meet any of the specifications or (b) any dissatisfaction or unhappiness with the design, package or labeling of such Product. Complaints comes to the manufacturer after selling of product to the market.

All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken.

A person responsible for handling the complaints and deciding the measures to be taken should be allocated, together with sufficient supporting staff to assist him or her.

There should be written procedures describing the action to be taken, including the need to consider a recall, in the case of a complaint concerning a possible product defect.

Special attention should be given to establishing that the product that gave rise to a complaint was defective.

Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated. The person responsible for Quality Assurance should normally be involved in the review of such investigations.

If a product defect is discovered or suspected in a batch, consideration should be given to whether other batches should be checked in order to determine whether they are also affected. In particular, other batches that may contain reprocessed product from the defective batch should be investigated.

Where necessary, appropriate follow-up action, possibly including product recall, should be taken after investigation and evaluation of the complaint.

All decisions made and measures taken as a result of a complaint should be recorded and referenced to the corresponding batch records.

Complaints records should be regularly reviewed for any indication of specific or repeating problems that require attention and might justify the recall of marketed products. The competent authorities should be informed if a manufacturer is considering action following possibly faulty manufacture, product deterioration, a suspect product or any other serious quality problems with a product.

Product Recalls :

What is Product Recall :

A product recall is a request from a manufacturer or company to return or removal of a marketed product after the discovery of safety issues or product defects that might threaten the consumer or put the company/seller/ manufacturer at risk of legal action.

There should be a system to recall the products from the market, promptly and effectively, products known or suspected to be defective.

The authorized person should be responsible for the execution and coordination of recalls. He or she should have sufficient staff to handle all aspects of the recalls with the appropriate degree of urgency.

 There should be established written procedures, which are regularly reviewed and updated, for the organization of any recall activity. Recall operations should be capable of being initiated promptly down to the required level in the distribution chain.

An instruction should be included in the written procedures to store recalled products in a secure segregated area while their fate is decided.

All competent authorities of all countries to which a given product has been distributed should be promptly informed of any intention to recall the product because it is, or is suspected of being, defective.

The distribution records should be readily available to the authorized person, and they should contain sufficient information on wholesalers and directly supplied customers (including, for exported products, those who have received samples for clinical tests and medical samples) to permit an effective recall.

The progress of the recall process should be monitored and recorded.

Records should include the disposition of the product and final report should be issued, including a reconciliation between the delivered and recovered quantities of the products.

The effectiveness of the arrangements for recalls should be tested and evaluated from time to time.

Mock recall to be performed at a regular interval to check the effectiveness of the recall.

To know the difference between recall vs Mock recall pl Refer :

Mock means Make a Duplicate or exact copy of something.


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