Transcription of GUIDELINES ON RECALL AND RAPID ALERT SYSTEM FOR …
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GUIDELINES ON RECALL AND RAPID ALERT SYSTEM FOR …
GUIDELINES ON RECALL AND RAPID ALERT SYSTEM FOR DRUGS (Including Biologicals & Vaccines) Document No : CDSCO/RRAS Ver. : 00 Effective Date : 23/11/2012 Central Drugs Standard Control Organisation Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhawan, ITO, Kotla Road, New Delhi -110002. TABLE OF CONTENTS Introduction 1 Background 1 Scope 1 Definitions 2 RECALL Classification 3 RECALL procedures 3 Voluntary RECALL 4 Statutory RECALL 4 Level of RECALL 5 Time Lines for Effective RECALL SYSTEM & RAPID ALERT 5 Procedure for RAPID ALERT & RECALL SYSTEM 6 Overview of Process Flow RAPID ALERT & RECALL SYSTEM 8 Stepwise RECALL Procedure 9 Follow-up Action of Recalled Goods 10 Mock RECALL 12 Abbreviations 12 References 13 Page 1 of 13 Introduction: RECALL is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety.
Central Drugs Standard Control Organisation Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhawan, ITO, Kotla Road, New Delhi -110002. ... Procedure for Rapid Alert & Recall System . 6. 10.0 Overview of Process Flow Rapid Alert & Recall System . 8. 11.0 Stepwise Recall Procedure . 9.
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