Book provides possible solutions to common issues faced in tablets, capsules, liquid orals, topical preparations and pharmaceutical water system departments. Next, a typical computerized asset management system is explained and how a company can implement it in their organization, keeping in mind regulatory and compliance issues. It addresses the issues involved with maintenance of various machines encountered in a pharmaceutical facility. Beginning with overview of companywide calibration program and maintenance and repair of electric motors and pumps (which form a part of most machines), procedures for cleaning and maintenance of each machine is provided individually. Maintaining and repairing common utilities like compressed air, boiler, HVAC/R and pharmaceutical water systems are also covered. The book explores the issues involved with work environment, safety, pest control, building maintenance and indoor-air quality. Procedures for creating a disaster management system for a facility are also explained. Guidelines for safety audit and workplace safety is explained from the view of good engineering practices and also special features encountered in pharmaceutical facilities. With a study of worldwide trends in regulatory inspections, it gives practical guidance for the plant staff to prepare for and manage a regulatory inspection. This book goes beyond the management aspect and delves deep into what inspectors are looking for when they come calling in various sections like tablet granulation, liquid packing etc.

Business Horizons
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