Pharmaceutical facility management: the plant manager's handbook / (Record no. 145540)

MARC details
000 -LEADER
fixed length control field 00382nam a2200133Ia 4500
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 8190078860
040 ## - CATALOGING SOURCE
Transcribing agency CUS
082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.1
Item number KOH/P
100 ## - MAIN ENTRY--PERSONAL NAME
Personal name Kohli, J.P.S.
245 #0 - TITLE STATEMENT
Title Pharmaceutical facility management: the plant manager's handbook /
Statement of responsibility, etc. J.P.S. Kohli
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc. New Delhi:
Name of publisher, distributor, etc. Business Horizons,
Date of publication, distribution, etc. 2005.
300 ## - PHYSICAL DESCRIPTION
Extent 311 p.
505 ## - FORMATTED CONTENTS NOTE
Formatted contents note 1 PRODUCTION ISSUES <br/>1.1 TABLETS/CAPSULES -- 1.2 LIQUID ORALS -- 1.3 TOPICAL PREPARATIONS -- 1.4 PHARMACEUTICAL WATER SYSTEMS<br/><br/>2 MASTER MAINTENANCE PROGRAM<br/>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 <br/><br/>3 EQUIPMENT CLEANING AND MAINTENANCE<br/>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<br/><br/>4 WORK ENVIRONMENT AND SAFETY<br/>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<br/><br/>5 TRAINING<br/>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<br/><br/>6 VALIDATION<br/>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<br/><br/>7 ENVIRONMENTAL MONITORING<br/>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 <br/><br/>8 REGULATORY INSPECTIONS<br/>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 -- <br/>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<br/><br/>References -- Reference Data for Plant Managers -- Index
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type General Books
Holdings
Withdrawn status Lost status Damaged status Not for loan Home library Current library Shelving location Date acquired Full call number Accession number Date last seen Date last checked out Koha item type
        Central Library, Sikkim University Central Library, Sikkim University General Book Section 28/08/2016 615.1 KOH/P P00167 07/02/2020 07/02/2020 General Books
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