兽药GMP检查验收中的常见问题分析

The Common Problems in GMP Inspection of Veterinary Drugs

兽药GMP认证工作主要是对相关人员、硬件与软件三大要素和验证、规程与记录三项重点工作进行考核与检查。其中,硬件是根本,软件是重点,人员是关键。记录是实施GMP认证的基础性工作,必须真实、详细;规程是兽药生产的规范性文件和行动指南,必须规范、合理,可操作性强;而验证则是GMP检查验收工作的精髓和重中之重,各项规程及标准等都必须通过验证。

GMP inspection of Veterinary drugs mainly covers three principle points including personnel, hardware and software, and also three key work including validation, protocols and records, hardware is fundamental, software is important and personnel are critical among them. Various records are the fundamental work in GMP inspection. It must be true and detailed. Various protocols are standard documents and behavior guidance in manufacturing of veterinary drugs. The validation is the critical point of key works in GMP inspection. All protocols and standards must pass the validation.