有关《药品生产质量管理规范(2010年修订)》的若干问题

摘要

The revised Code for quality management of drug manufacture (2010) is further closer to the international standards. It is helpful to improve the medicine quality of China and to enter the international market. Provides some ideas and suggestions on the issues possibly occurred in implementation of the code such as cleanness classes, occupied conditions, testing point minimum sample amount, static pressure difference between different cleanliness classes, standby operating conditions, etc.%修订的2010版《药品生产质量管理规范》与国际标准更加接轨,有助于我国药品质量的提高和走向国际市场.就修编规范实施时可能存在的一些问题,如洁净度等级、检测时占用状态、测点最小采样量、不同洁净级别的静压差、值班工况等,提出了看法与建议.