ispe先进调试及确认理念在新版gmp实施过程中的应用.docVIP

ISPE-CCPIE CHINA CONFERENCE 2011 Application of advanced ISPE CQ concepts in GMP Austar Peter Ma peterma@October 25-28 2011 Shanghai 1 Content ? ISPE Guideline Overview ? Case Study ? Risk Assessment ? Commissioning and Qualification (CQ) ISPE-CCPIE CHINA CONFERENCE 2011 ISPE Guideline Overview ? Baseline? Pharmaceutical Engineering Guides – Active Pharmaceutical Ingredients, a Revision of Bulk Pharmaceutical Chemicals – Oral Solid Dosage Forms Baseline? Guide (Second Edition) – Sterile Manufacturing Facilities – Water and Steam Systems – Commissioning and Qualification – Biopharmaceutical Manufacturing Facilities – ISPE Baseline? Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) ISPE Guideline Overview ? GAMP? Guidance Documents – GAMP? 5: A Risk-Based Approach to Compliant GxP Computerized Systems – GAMP? Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) – GAMP? Good Practice Guide: A Risk Based Approach to Calibration Management (Second Edition) – GAMP? Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP? 5 – GAMP? Good Practice Guide: Manufacturing Execution Systems -A Strategic and Program Management Approach – Electronic Data Archiving – Global Information Systems Control and Compliance – IT Infrastructure Control and Compliance – Validation of Laboratory Computerized Systems – A Risk-Based Approach to Compliant Electronic Records and Signatures ISPE Guideline Overview ? ISPE Good Practice Guides – Heating, Ventilation, and Air Conditioning (HVAC) – Maintenance – Good Engineering Practice – Development of Investigational Therapeutic Biological Products – Commissioning and Qualification of Pharmaceutical Water and Steam Systems – Assessing the Particulate Containment Performance of Pharmaceutical Equipment – Technology Transfer