Complaints and Product Recalls
5. Complaints:
5.1 Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken.
5.2 A person responsible for handling the complaints and deciding the measures to be taken should be designated, together with sufficient supporting staff to assist him or her. If this person is different from the authorized person, the latter should be made aware of any complaint, investigation or recall.
5.3 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.
5.4 Special attention should be given to establishing that the product that gave rise to a complaint was defective.
5.5 Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated. The person responsible for QC should normally be involved in the review of such investigations.
5.6 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.
5.7 Where necessary, appropriate follow-up action, possibly including product recall, should be taken after investigation and evaluation of the complaint.
5.8 All decisions made and measures taken as a result of a complaint should be recorded and referenced to the corresponding batch records.
5.9 Complaints records should be regularly reviewed for any indication of specific or recurring problems that require attention and might justify the recall of marketed products.
5.10 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.
6. Product Recalls:
6.1 Principle. There should be a system to recall from the market, promptly and effectively, products known or suspected to be defective.
6.2 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.
6.3 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.
6.4 An instruction should be included in the written procedures to store recalled products in a secure segregated area while their fate is decided.
6.5 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.
6.6 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.
6.7 The progress of the recall process should be monitored and recorded. Records should include the disposition of the product. A final report should be issued, including a reconciliation between the delivered and recovered quantities of the products.
6.8 The effectiveness of the arrangements for recalls should be tested and evaluated from time to time.
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles
(Annex 2, WHO Technical Report Series 986, 2014)
