Pharmaceutical facility management: the plant manager's handbook / J.P.S. Kohli

1 PRODUCTION ISSUES
1.1 TABLETS/CAPSULES -- 1.2 LIQUID ORALS -- 1.3 TOPICAL PREPARATIONS -- 1.4 PHARMACEUTICAL WATER SYSTEMS

2 MASTER MAINTENANCE PROGRAM
2.1 INTRODUCTION -- 2.2 COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEMS (CMMS) -- 2.3 ADVANTAGES OF CMMS -- 2.4 GUIDELINES FOR SMALL COMPANIES -- 2.5 IMPLEMENTATION OF CMMS -- 2.6 AUTOMATIC DATA COLLECTION -- 2.7 ELEMENTS OF CMMS -- 2.8 WORK ORDERS -- 2.9 ASSETS -- 2.10 PREVENTIVE MAINTENANCE -- 2.11 . MASTERS -- 2.12 REPORTS -- 2.13 SETTING UP A MACHINE SHOP -- 2.14 REGULATORY AND COMPLIANCE ISSUES

3 EQUIPMENT CLEANING AND MAINTENANCE
3.1 INTRODUCTION -- 3.2 CALIBRATION OF EQUIPMENT -- 3.3 ELECTRIC MOTORS -- 3.4 CENTRIFUGAL PUMPS -- 3.5 FLUID BED DRYER -- 3.6 MASS MIXER -- 3.7 MULTIMILL -- 3.8 PLANETARY MIXER -- 3.9 HIGH SHEAR MIXER GRANULATOR (RAPID MIXER GRANULATOR) -- 3.10 SIFTER -- 3.11 TRAY DRYER -- 3.12 WURSTER COATER DRYER -- 3.13 DOUBLE CONE BLENDER -- 3.14 TABLET COMPRESSION MACHINE -- 3.15 VIBRATORY TABLET DE-DUSTER -- 3.16 CONVENTIONAL COATING PAN -- 3.17 POLISHING PAN -- 3.18 STRIP SEALING MACHINE -- 3.19 CAPSULE AUTOLOADER -- 3.20 CAPSULE INSPECTION CUM POLISHING MACHINE -- 3.21 DRY SYRUP POWDER FILLING MACHINE -- 3.22 CAPSULE FILLING MACHINE (MANUAL) -- 3.23 CAPSULE FILLING MACHINE (SEMI-AUTOMATIC) -- 3.24 TANKS, ACCESSORIES, UTENSILS AND STIRRERS -- 3.25 FILTER PRESS -- 3.26 LIQUID ORAL FILLING MACHINE -- 3.27 BOTTLE LABELLING MACHINE -- 3.28 COMPONENT PREPARATION TANK -- 3.29 MELTING TANK -- 3.30 OINTMENT MIXER (SILVERSON TYPE) -- 3.31 OINTMENT BULK STORAGE DRUM -- 3.32 TUBE FILLING MACHINE -- 3.33 EQUIPMENT FOR STERILE PRODUCTS (General) -- 3.34 STERILE PRODUCT VESSELS -- 3.35 STIRRER -- 3.36 VIALS/AMPOULES WASHING MACHINE -- 3.37 RUBBER STOPPER WASHING MACHINE -- 3.38 MEMBRANE FILTER HOLDER -- 3.39 FILTRATION TUBING -- 3.40 AMPOULE FILLING AND SEALING MACHINE -- 3.41 VIAL/AMPOULE FILLING ASSEMBLIES AND ACCESSORIES -- 3.42 AUTOCLAVE -- 3.43 VIAL SEALING MACHINE -- 3.44 VIAL/AMPOULE INSPECTION MACHINE -- 3.45 COMPRESSED AIR -- 3.46 BOILER -- 3.47 HVAC/R -- 3.48 PHARMACEUTICAL WATER

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