摘要
将风险管理理念贯穿于整个工艺验证周期,运用质量风险管理工具对药品生产工艺进行风险评估,确定关键步骤及关键工艺参数,制定验证计划。通过风险管理可以有效提高药品生产工艺验证的针对性,提高药品生产工艺验证效率,降低日后商业化大生产规模下可能出现的生产风险。
Applied risk management throughout the process validation cycle, taking quality risk management tools to assess the drug production process, determine the critical steps and key process parameters. Than make the validation plan. By using the risk management can effectively improve the pertinence of drug production process validation, and it can also improve the efficiency of drug production process validation, reduce the commercial production scale production risks that may occur in the future.
关键词
生产工艺
工艺验证
风险管理
Production Process
Risk management
Process validation
