![]() 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 : ![]() The Management Dictionary covers over 2000 business concepts from 5 categories.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. The content on MBA Skool has been created for educational & academic purpose only.īrowse the definition and meaning of more similar terms. It has been reviewed & published by the MBA Skool Team. This article has been researched & authored by the Business Concepts Team. An initiator may or may not be the final consumer or the customer but does play a crucial role in the final purchase of the product. Usually, the initiator is one who would benefit the most from the subsequent purchase and has a vested interest in it. Consequently, he would push the actual purchaser (his parents) towards the follow on stages of the decision process. INITIATER DEFINITION TVThis need may have arisen when he might have seen ads of Plasma TV’s or had the experience of TV at friends’ place. Marketers usually target potential initiators, at times implanting a specific need/want or helping them prioritize one.įor instance, in a nuclear family with a son and a daughter, the son may feel the need for buying a Plasma Television instead of the flat TV the family currently has. He is the person who starts the decision making process by recognizing that a particular problem needs to be addressed to satisfy a specific need. Initiator is a person who identifies a need and triggers a purchase decision. Any consumer decision making process involves a host of people. ![]()
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