对无菌产品和最终灭菌产品经济环境监测程序.pdfVIP

ISPE-CCPIE CHINA CONFERENCE 2011 The cost effective environmental monitoring programme for aseptic and terminally sterilised products R A WALKER October 25-28 2011 Shanghai 1 Environmental Monitoring Article 12 The basic requirements of Quality Control are that: 2. Approved procedures are available for sampling, inspection and testing starting materials, packaging materials, intermediate, bulk, and finished products, and stability study, and, where appropriate, for monitoring environmental conditions, to ensure the compliance with GMP. ISPE-CCPIE CHINA CONFERENCE 2011 2 Environmental Monitoring GMP Guide • Article 24: The heads of production and quality management generally have some shared, or jointly exercised, responsibilities relating to quality, including: 2. The monitoring of manufacturing environment and plant hygiene; ISPE-CCPIE CHINA CONFERENCE 2011 3 Environmental Monitoring GMP Guide • Article 183: There should be operation procedures and the associated records of actions taken and conclusions reached for: Item 5. Environmental monitoring ISPE-CCPIE CHINA CONFERENCE 2011 4 Environmental Monitoring GMP Guide • Article 221 point 3 • For some kinds of data (e.g. testing results, environment monitoring data, microorganism monitoring data of water for pharmaceutical use), it is recommended that records be kept in a manner permitting trend evaluation. ISPE-CCPIE CHINA CONFERENCE 2011 5 Annex 1; Article 11 • Monitoring in operation should be done on microbiological levels to evaluate its