4 WORK ENVIRONMENT AND SAFETY 4.1 HOUSEKEEPING -- 4.2 PEST CONTROL AND DISINFECTION -- 4.3 MANAGING OLDER BUILDINGS -- 4.4 ROOFING MAINTENANCE -- 4.5 INDOOR AIR QUALITY -- 4.6 DISASTER MANAGEMENT -- 4.7 SAFETY -- 4.8 ELECTRICAL SAFETY
5 TRAINING 5.1 INTRODUCTION -- 5.2 WRITING A TRAINING PROGRAM -- 5.3 STRUCTURE OF TRAINING PROGRAMS -- 5.4 CONDUCTING TRAINING SESSIONS -- 5.5 TIPS TO BECOME A BETTER TRAINER -- 5.6 ASSESSMENT -- 5.7 DOCUMENTATION OF TRAINING -- 5.8 A CASE STUDY -- 5.9 SAMPLE TRAINING PROGRAMS
6 VALIDATION 6.1 INTRODUCTION -- 6.2 PURPOSE OF VALIDATION AND QUALIFICATION -- 6.3 RESPONSIBILITY FOR VALIDATION AND QUALIFICATION -- 6.4 VALIDATION MASTER PLAN -- 6.5 INSTALLATION AND OPERATIONAL QUALIFICATION -- 6.6 NON-STERILE PROCESS VALIDATION -- 6.7 CHANGE CONTROL -- 6.8 CLEANING VALIDATION -- 6 8 SAMPLE FORMATS
7 ENVIRONMENTAL MONITORING 7.1 INTRODUCTION -- 7.2 PHARMACEUTICAL PRODUCTS -- 7.3 INDUSTRIAL PROCESSES IN THE PHARMACEUTICAL INDUSTRY -- 7.4 RAW MATERIAL INPUTS AND POLLUTANT OUTPUTS -- 7.5 AIR POLLUTION -- 7.6 AIR POLLUTION CONTROL EQUIPMENT -- 7.7 WASTEWATER -- 7.8 SOLID WASTES -- 7.9 POLLUTION PREVENTION -- 7.10 GOOD OPERATING PRACTICES
8 REGULATORY INSPECTIONS 8.1 INTRODUCTION -- 8.2 TRENDS IN REGULATORY INSPECTIONS -- 8.3 MANAGING REGULATORY INSPECTIONS -- 8.4 INSPECTION OF QUALITY SYSTEMS/GMP AUDIT -- 8.5 INSPECTION OF TABLET/CAPSULE SECTION -- 8.6 INSPECTION OF LIQUID ORALS SECTION -- 8.7 INSPECTION OF TOPICAL PRODUCTS SECTION -- 8.8 INSPECTION OF STERILE PRODUCTS -- 8.9 INSPECTIONS OF QUALITY CONTROL LABORATORIES -- 8.10 INSPECTION OF UTILITIES
References -- Reference Data for Plant Managers -- Index