首页 > 资讯 > 加拿大卫生部更新生物制品和血液制品的cGMP指南

出自识林

2012-11-12 Health Canada

加拿大卫生部更新了其生物制品和人血制品相关cGMP指南，更新包括生产场所、设备、人员、卫生、原材料检测、生产控制、质量控制部门、包装材料测试、记录、样品、稳定性等11个主要方面，新指南取代了1999年的版本，于2012年11月9日生效。

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Premises: Sets recommendations for manufacturing facilities, including screening areas for blood donors, secured quarantine storage and handling areas, separate areas for testing biological samples and storage requirements.

Equipment: Sets recommendations for laboratory testing equipment, water purification systems, equipment validation and maintenance, equipment used for specific procedures, the safety of collection procedures and the validation of computers used to maintain patient data.

Personnel: Sets recommendations for managerial authority, staff training, staff qualifications, continuing education, key staff roles and educational requirements.

Sanitation: Sets recommendations for the maintenance of a clean and sanitary manufacturing facility, the establishment of safety procedures, personnel control and hygiene and sanitary procedures for staff.

Raw Material Testing: Sets recommendations for donor screening and vendor audits.

Manufacturing Control: Sets recommendations for operating procedures, document control, the documentation of all significant operational steps, document change control procedures, supply and reagent controls, component labeling, recall procedures and audits.

Quality Control Department: Sets recommendations for the personnel makeup of the facility's quality control department and operations, including the formation of a quality control program.

Packaging Material Testing: Sets recommendations for the use of approved blood product collection and satellite bags—both of which are approved as medical devices through a separate process and do not require further testing.

Records: Sets recommendations for record keeping, including legibility and content.

Samples: Sets recommendations for transfusion samples, which much be stored in a frozen state if stored long-term.

Stability: Sets recommendations for storage and shipment.