Description
Business Horizons Pharmaceutical Facility Management by Jps Kohli
The new second edition of this bestselling book is bigger, better and takes the reader to the next level and future ready. While the earlier edition was all about smooth and troublefree working of a pharmaceutical facility, the new second edition strives to achieve excellence and set industry benchmarks for facilities of the future. The pharmaceutical facilities of today must reach out beyond the routine and strive for excellence in all spheres of activity, to enable the company retain its competitive edge in the marketplace. To put the facility manager firmly in control of the entire facility, a new chapter has been created specifically to focus on facility manager and the roles and responsibilities that compose the job description of this position. Social responsibility towards the planet we inhabit has been recognized as our unfailing duty and ways to sustain the ecosystem are constantly being evolved. Since pharmaceutical manufacturing facilities impose lots of demands on the physical environment in which they exist, innovative companies are always trying to lessen their carbon footprint through various methodologies being evolved. What is today seen as innovation will perhaps become mandatory in the near future and hence a new chapter has been introduced called Sustainable Facilities that suggests various means by which a company can reduce its carbon footprint. The most exciting change however in the new edition is the introduction of a new chapter, ''Operational Excellence in Pharma Manufacturing'' which focuses on manufacturing efficiency for the first time, focusing on actual shop floor strategies rather than arcane management fuzzy logic formulas. While current efficiency levels in the pharmaceutical industry are examined, avenues for excellence are explored that include continuous processing of pharmaceuticals, automated manufacturing, optimizing batch sizes and cycle times and overall equipment effectiveness (OEE). A company can thus develop its own corporate manufacturing strategy based on the technology level it is willing to upgrade to, market and business demands and the resources required for such project. All other chapters have been thoroughly overhauled, outdated information removed and current and up-to-date information included to transform the existing chapters to cutting edge contemporary standards. CONTENTS MANAGING PHARMACEUTICAL FACILITIES Introduction Role of a Facility Manager Financial Management Facilities Condition Assessment (Audit) Pharmaceutical Facility Validation Facility Design Qualification Facility Installation Qualification Facility Operational Qualification Utility Systems Safety for Facility Management SUSTAINABLE FACILITIES Ecosystems Sustainable Manufacturing Current Scenario Green Chemistry Process Mass Intensity Green Solvents Green Engineering Sustainable Buildings Sustainable Energy Management Cleanrooms (HVAC) Facility Lighting Electric Motors Compressed Air Boilers Sustainable Water Management OPERATIONAL EXCELLENCE IN PHARMA MANUFACTURING Introduction Focus on Manufacturing Efficiency Current Efficiency Levels Continuous Processing of Pharmaceuticals Automated Manufacturing Good Automated Manufacturing Practices (GAMP) ASTM E2500 Optimizing Batch Sizes and Cycle Times Overall Equipment Effectiveness Corporate Manufacturing Strategy PRODUCTION ISSUES EQUIPMENT CLEANING AND MAINTENANCE COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM WORK ENVIRONMENT AND SAFETY TRAINING VALIDATION ENVIRONMENTAL MONITORING REGULATORY INSPECTIONS