制药用水系统的设计要点.pdfVIP

制药及生物制药行业设备的清洗方案 王伟(上海净泽洁净设备有限公司) Contents 1 法规要求 2 设备清洗和验证方法的确认 3 清洗的技术问题 4 案例 Section 1 设备清洗的法规要求 3 Winatech page FDA 法规  cGMP Part 211.67  - Equipment Cleaning and Maintenance  §211.67 Equipment cleaning and maintenance.  (a) Equipment and utensils shall be cleaned, maintained, and sanitized at  appropriate intervals to prevent malfunctions or contamination that would alter  the safety, identity, strength, quality, or purity of the drug product beyond  the official or other established requirements.  (b) Written procedures shall be established and followed for cleaning and  maintenance of equipment, including utensils, used in the manufacture,  processing, packing, or holding of a drug product. These procedures shall  include, but are not necessarily limited to, the following:  (1) Assignment of responsibility for cleaning and maintaining equipment;  (2) Maintenance and cleaning schedules, including, where appropriate, sanitizing  schedules;  (3) A description in sufficient detail of the methods, equipment, and materials  used in cleaning and maintenance operations, and the methods of disassembling  and reassembling equipment as necessary to assure proper cleaning and  maintenance;  (4) Removal or obliteration of previous batch identification;  (5) Protection of clean equipment from contamination prior to use;  18  (6) Inspection of equipment for cleanliness immediately before use.  (c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection  as specified in §§211.180