iso13485包装验证控制程序3.doc

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1、包装验证控制程序 1、目的                                                                                                                                        对无菌医疗器械产品生产的包装过程进行有效控制，确保经环氧乙烷灭菌产品的包装有效性。                                                                                         

2、                                                    2、范围本程序规定了无菌医疗器械产品包装工艺过程验证的管理职责、工作程序、内容和要求。                                                                                                                                                                                        

3、                                                                                          本程序适用于环氧乙烷灭菌产品包装的控制，以及包装验证方案、报告的编制。                                                                                                                                                          

4、                   3、职责                                                                                                                                        3.1生产部负责成品包装过程的控制。                                                                                                      

5、                                                    3.2生产车间负责成品的包装工作。                                                                                                                                                          3.3技术部负责成品包装验证方案的编制。                                    

6、                                                                                                                      3.4质检部负责成品包装的检查验证,并形成包装验证报告。                                                                                                                                     

7、                     4、控制程序                                                                                                                                        4.1包装材料确定的原则                                                                                                        

8、