The use of, or exposure to, a defective product which may cause temporary adverse health consequences or illness of user, following are the examples but not limited to:.Mix-up or use of wrong primary packaging materials.Product not meeting the regulatory specifications.A reasonable probability that the use of, or exposure to, a defective product will cause defects which shall be potentially life-threatening or could cause serious health consequences or death to the user, following are the examples but not limited to:.Product Recall is further classified into three Classes.Product/Label mix-up which may cause a potential health hazard to the consumer or user.Represent a health hazard or suspected adverse event to the consumer or user.Complaints concerning a possible defect are found to be correct and may cause a potential hazard to the consumer or user.The identification of the potential root cause(s) of the quality defect.
The internal and external communications that should be made in relation to a quality defect/reported failure and its investigation.The assessment of the impact that any recall action may have on the availability of the medicinal product to patients in any affected market, and the need to notify the relevant authorities of such impact.The decision-making process that is to be used concerning the potential need for risk-reducing actions to be taken in the distribution network, such as batch or product recalls, or other actions.The impact and risk assessment of reported quality defect or failure shall be performed, based on the severity and extent of the quality defect or reported failure.The checking or testing of reference and/or retention samples shall be considered as part of this, and in certain cases, a review of the batch production record, the batch release record, and the batch distribution records (especially for temperature-sensitive products) shall be performed.The determination of the extent of the quality defect.Procedure for the handling of the reported quality defect.The investigation shall cover the following but not limited to:.Investigation of quality defect or reported failure shall be investigated following SOP for “ Handling of Market Complaints” & SOP for Corrective and Preventive Actions ( CAPA).Local drug authority or any other regulatory authority of the export market or qualified person (QP) of the respective market. In addition to this, the recall may be initiated by a competent authority e.g.Head QA shall initiate the recall process for any product.In case of failure to meet the specification during the shelf life of the products.In case the sample failed in analysis tested by National Medicine Laboratories or by private testing laboratories.If manufacturers, wholesalers, retailers, and hospital pharmacists report the possible occurrence of health risk.If there is a market complaint about the product’s risk.Recall can be initiated in the following cases but not limited to:.Type of recall is Voluntary recall and statutory recall.The recall is described as the removal of a specific batch /batches of a product from the market due to deficiencies in the quality, identity safety, and efficacy.Liasoning with media in case of drug product recalls.Ĥ.0 Procedure for Product Recall and Mock Recall : Plan & test the subjected batch/product and conduct investigationĮnsuring Recall (product / mock) complying with international & regulatory requirements Provide analytical data related to RM, PM, and Product Reviewing the effectiveness of product Recall and Mock Recall.įacilitating Mock Recall from all distribution points ensuring stoppage of further sale and distribution of suspected batch. Notification to Qualified Person and importers with the complete investigation and other details as applicable/required. This SOP is applicable to the recall of unsatisfactory products from the market and Mock Recall trials.Ĭo-ordinates all recall-related activities.To lay down a procedure for prompt and effective recall (Mock & Drug Product) of finished products known or suspected to be defective from Domestic and International Market.SOP for Mock Recall & Drug Product Recall 1.0 Objective : Standard Operating Procedure for Mock Recall and Drug Product Recall, The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety, or efficacy, including labeling considered to be in violation of the laws.
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