PIC PE 010--3(中英文版).docVIP

PHARMACEUTICAL INSPECTION CONVENTION 药物检查会议 PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME 药物检查合作纲要 PI 010-3 25 September 2007/PI 010-3 2007年9月25日 STANDARD OPERATING PROCEDURE 标准操作程序（SOP） PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS 质量缺陷引起的召回和快速预警的处理程序 ? PIC/S September 2007 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. ? PIC/S 2007.9 禁止商业用途的复印 授权可复印作内部使用 对来源的提供表示感谢 Editor: PIC/S Secretariat/编者：PIC/S 秘书处 e-mail: info@ web site: TABLE OF CONTENTS/目录 Page/页码 1. Document history/文件的历史 1 2. Introduction /简介1 3. Purpose and scope/目的范围2 4. Criteria for issuing a rapid alert.发布快速预警的标准2 5. Issue of a rapid alert notification/快速预警通告的发布3 6. Fraud and counterfeit products/假冒伪劣产品4 7. Follow-up action/后续行动4 8. Appendices /附录4 9. Revision history/版本的历史4 1. DOCUMENT HISTORY/文件的历史 Adoption by the PIC/S Committee 24 April 2002 Entry into force 1 July 2002 PIC/S 委员会通过 2002.4.24 生效 2002.7.1 2. INTRODUCTION/简介 2.1 In order to protect public health and animal health it may become necessary to implement urgent measures such as the recall of one or more defective batch(es) of a medicinal product during its marketing period. 为了公共卫生和动物，动物，采取紧急措施会变得很有必要，比如对市场上的一批或超过一批的有缺陷的医药产品的召回。 2.2 Each Competent Authority should have written procedure which covers the receipt and handling of notifications of suspected defective products and batch recalls from companies or health professionals both during and outside normal working hours. 每一主管当局都应有书面程序，该程序包括：不论在正常的工作时间内、外，对被怀疑有缺陷的产品和批次通告的接受和处理。 2.3 The Competent Authority of each party should assist the authorisation holder in the recall process, as appropriate, and monitor its effectiveness. The Competent Authority should ensure that information concerning the recall of medicinal products is notified rapidly to other parties, if the nature of the defect presents a serious risk to