Pharmaceutical Facility Management

EDITOR: J. P. S. Kohli
PUBLISHER: Business Horizons
ISBN: 9788190078863
YEAR: 2005 – First Edition
PAGES: 311
SIZE: 18.5 X 25 X 2 cm.
BINDING: Hard
LANGUAGE: English

ABOUT THE BOOK: Business entities have come to realize that maintaining a well-managed and highly efficient facility is critical to success. New technologies, security issues and health concerns also have had a major impact on the importance of, and need for, facility professionals in organizations. Plant managers must therefore be equipped with a tremendous amount of knowledge and the ability to cope with and solve a multitude of complex problems and challenges. The current climate of increased inspections and scrutiny from the regulatory authorities on manufacturing, combined with the uncertainty of the equity markets, has elevated GMP compliance to a long-term business strategy. This unique book covers the often overlooked field of pharmaceutical facility management. In a running pharmaceutical plant, the plant manager often has to manage a wide range of activities including production, machine maintenance, building maintenance, training of personnel, validation programs, environmental monitoring and last but not the least – managing regulatory inspections. This wide spectrum of activities entails the involvement of people from production, quality control, engineering, quality assurance, housekeeping etc. thus demanding a lot of time and efforts from the plant manager to effectively synchronize all these activities. This book will help in designing and implementing all these required activities and help in streamlining the total functioning of a pharmaceutical facility. This is a must-have book that all plant managers and others involved with a pharmaceutical manufacturing facility should have on their tables for ready reference.

ABOUT THE EDITOR: J. P. S. Kohli is a pharmacy graduate from University of Delhi followed by Diploma in Management of Technology Transfer, Patents and Information Systems. He has wide ranging experience in the pharmaceutical industry, having worked in a pharmaceutical engineering company followed by working in a pharmaceutical manufacturing facility as Manager-Projects and Exports. He later set up his own pharmaceutical engineering company providing technical audit services and engineering consultancy to pharmaceutical companies for all dosage forms like Tablets, Capsules, Dry Syrups, Liquid Orals, Ointments and Injectables.

CONTENTS:
Preface

1. PRODUCTION ISSUES
    a. TABLETS/CAPSULES
        i. Introduction
        ii. Blenders
        iii. Dryers
        iv. Tablet and Capsule Equipment
        v. Granulation Mix Analysis
        vi. In Process Testing
        vii. Process Notes
        viii. Common Problems in Tabletting
    b. LIQUID ORALS
        i. Process Notes
    c. TOPICAL PREPARATIONS
        i. Potency Uniformity
        ii. Equipment and Production Control
        iii. Preservatives Used in Topical Preparations
        iv. Preservatives Used in Ophthalmic Preparations
    d. PHARMACEUTICAL WATER SYSTEMS
        i. System Validation
        ii. Microbial Limits
        iii. Water for Injection Systems
        iv. Purified Water Systems

2. MASTER MAINTENANCE PROGRAM
    a. INTRODUCTION
    b. COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEMS (CMMS)
    c. ADVANTAGES OF CMMS
    d. GUIDELINES FOR SMALL COMPANIES
    e. IMPLEMENTATION OF CMMS
        i. Implementation Basics
        ii. Framework for Transition
        iii. Preventive Maintenance
        iv. Continuous Process
    f. AUTOMATIC DATA COLLECTION
    g. ELEMENTS OF CMMS
        i. Work Order
        ii. Assets
        iii. Location
        iv. Preventive
        v. Employee
        vi. Masters
        vii. Reports
    h. WORK ORDERS
        i. How to Open a New Work Order
        ii. Filter Out Work Order Information
        iii. Close a Work Order
        iv. Add Labour In The Work Order
        v. Direct Issue In a Work Order
        vi. View Total Cost of a Work Order
    i. ASSETS
        i. Add a New Asset
        ii. How To Filter out Assets Information
        iii. Add a New Location
        iv. Filter Out Location Information
        v. Employee/Requester
        vi. Add a New Asset
        vii. Add a New Employee/Requester
        viii. Filter Out Employee/Requester Information
    j. PREVENTIVE MAINTENANCE
        i. Register a New PM Task
        ii. Filter Preventive Maintenance Schedules
        iii. Generate PM Work Orders
    k. MASTERS
        i. Department
        ii. Failure Code
        iii. Assets Category
        iv. Suppliers
        v. Contractors
    l. REPORTS
    m. SETTING UP A MACHINE SHOP
        i. Guidelines and Suggestions
        ii. Safety
        iii. Maintenance
    n. REGULATORY AND COMPLIANCE ISSUES

3. EQUIPMENT CLEANING AND MAINTENANCE
    a. INTRODUCTION
    b. CALIBRATION OF EQUIPMENT
        i. Procedure
        ii. Calibration Program
        iii. Calibration Standards
        iv. Calibration Procedures
        v. Instrument Maintenance Records
        vi. Calibration Instruments
    c. ELECTRIC MOTORS
        i. Basic guidelines
        ii. Motor Repair / Replacement Decisions
        iii. Economic Comparison
    d. CENTRIFUGAL PUMPS
    e. FLUID BED DRYER
    f. MASS MIXER
    g. MULTIMILL
    h. PLANETARY MIXER
    i. HIGH SHEAR MIXER GRANULATOR (RAPID MIXER GRANULATOR)
    j. SIFTER
    k. TRAY DRYER
    l. WURSTER COATER DRYER
    m. DOUBLE CONE BLENDER
    n. TABLET COMPRESSION MACHINE
        i. Inspection and Maintenance of Compression Tooling
        ii. Common Problems Encountered with Tablet Tooling
    o. VIBRATORY TABLET DE-DUSTER
    p. CONVENTIONAL COATING PAN
    q. POLISHING PAN
    r. STRIP SEALING MACHINE
    s. CAPSULE AUTOLOADER
    t. CAPSULE INSPECTION CUM POLISHING MACHINE
    u. DRY SYRUP POWDER FILLING MACHINE
    v. CAPSULE FILLING MACHINE (MANUAL)
    w. CAPSULE FILLING MACHINE (SEMI-AUTOMATIC)
    x. TANKS, ACCESSORIES, UTENSILS AND STIRRERS
    y. FILTER PRESS
    z. LIQUID ORAL FILLING MACHINE
    aa. BOTTLE LABELLING MACHINE
    bb. COMPONENT PREPARATION TANK
    cc. MELTING TANK
    dd. OINTMENT MIXER (SILVERSON TYPE)
    ee. OINTMENT BULK STORAGE DRUM
    ff. TUBE FILLING MACHINE
    gg. EQUIPMENT FOR STERILE PRODUCTS (General)
    hh. STERILE PRODUCT VESSELS
    ii. STIRRER
    jj. VIALS /AMPOULES WASHING MACHINE
    kk. RUBBER STOPPER WASHING MACHINE
    ll. MEMBRANE FILTER HOLDER
    mm. FILTRATION TUBING
    nn. AMPOULE FILLING AND SEALING MACHINE
    oo. VIAL /AMPOULE FILLING ASSEMBLIES AND ACCESSORIES
    pp. AUTOCLAVE
    qq. VIAL SEALING MACHINE
    rr. VIAL/AMPOULE INSPECTION MACHINE
    ss. COMPRESSED AIR
    tt. BOILER
        i. The Boiler Room
        ii. Piping Systems
        iii. Steam Traps
        iv. Water Treatment
        v. Pumps
        vi. The Venting System
        vii. The Boiler
        viii. Test Firing
    uu. HVAC/R
        i. Fans
        ii. Air-Handling Unit
        iii. Chillers and Condensers
        iv. Cooling Towers
        v. Ducts Cleaning
        vi. Clean Room Monitoring
        vii. Safety Tips for HVAC Maintenance
    vv. PHARMACEUTICAL WATER
        i. Cleaning of Piping
        ii. Passivation
        iii. Sanitization

4. WORK ENVIRONMENT AND SAFETY
    a. HOUSEKEEPING
        i. Introduction
        ii. Capsule Department
        iii. Tablet Department
        iv. Liquid Oral Department
        v. Ointment Department
        vi. Sterile Area
        vii. Raw, Packing and Finished Goods Stores
    b. PEST CONTROL AND DISINFECTION
    c. MANAGING OLDER BUILDINGS
    d. ROOFING MAINTENANCE
    e. INDOOR AIR QUALITY
    f. DISASTER MANAGEMENT
        i. Planning for an Emergency
        ii. Damage Control
    g. SAFETY
        i. Introduction
        ii. Safety Audits
        iii. Pharmaceutical Hazardous Areas
        iv. Safety Procedures
        v. Hazards Specific to Pharmaceutical Industry
        vi. Pharmaceutical Manufacturing Precautions
        vii. Personal Protective Equipment
    h. ELECTRICAL SAFETY
        i. Electrical Safety Regulations and Standards
        ii. Electrical Safety Program
        iii. Electrical Hazards
        iv. Work Procedures, Tools and PPE
        v. Safety by Design
        vi. First Aid

5. TRAINING
    a. INTRODUCTION
    b. WRITING A TRAINING PROGRAM
    c. STRUCTURE OF TRAINING PROGRAMS
    d. CONDUCTING TRAINING SESSIONS
        i. Class
        ii. Objectives
        iii. Material
        iv. Props
        v. Lesson Plan
        vi. Environment
        vii. Training Pointers
    e. TIPS TO BECOME A BETTER TRAINER
        i. Presentation Skills
        ii. Body Language
        iii. The Role of Questions
    f. ASSESSMENT
    g. DOCUMENTATION OF TRAINING
    h. A CASE STUDY
    i. SAMPLE TRAINING PROGRAMS
        i. Training Program for Supervisors
        ii. Training Program for Workmen
        iii. Training Program for Clean Room
        iv. Training Program for Autoclave
        v. Training Program for Dry Heat Sterilizer
        vi. Training Program for Janitors
        vii. Training Program for Laminar Air-Flow
        viii. Training Program for Membrane Filter Holder
        ix. Training Program for Personal Hygiene
        x. Training Program for Production Supervisor
        xi. Training Program for Sterile Stoppering
        xii. Training Program for The Workmen

6. VALIDATION
    a. INTRODUCTION
    b. PURPOSE OF VALIDATION AND QUALIFICATION
    c. RESPONSIBILITY FOR VALIDATION AND QUALIFICATION
    d. VALIDATION MASTER PLAN
        i. Purpose
        ii. Format and Content
    e. INSTALLATION AND OPERATIONAL QUALIFICATION
        i. Introduction
        ii. Installation Qualification (lQ)
        iii. Operational Qualification (OQ)
        iv. Re-Qualification
    f. NON-STERILE PROCESS VALIDATION
        i. Introduction
        ii. Prospective Validation
        iii. Concurrent Validation
        iv. Retrospective Validation
        v. Re-validation
    g. CHANGE CONTROL
    h. CLEANING VALIDATION
        i. Introduction
        ii. Documentation
    i. SAMPLE FORMATS

7. ENVIRONMENTAL MONITORING
    a. INTRODUCTION
    b. PHARMACEUTICAL PRODUCTS
        i. Botanicals
        ii. Pharmaceutical Preparations
        iii. Diagnostic Substances
        iv. Biological Products
    c. INDUSTRIAL PROCESSES IN THE PHARMACEUTICAL INDUSTRY
        i. Research and Development
        ii. Production of Bulk Pharmaceutical Chemicals
        iii. Formulation into Final Dosage Forms
    d. RAW MATERIAL INPUTS AND POLLUTANT OUTPUTS
    e. AIR POLLUTION
        i. Bulk Manufacturing
        ii. Formulation
    f. AIR POLLUTION CONTROL EQUIPMENT
        i. Condensers
        ii. Scrubbers
        iii. Combustion or Incineration
        iv. Adsorption
    g. WASTEWATER
    h. SOLID WASTES
    i. POLLUTION PREVENTION
        i. Material Substitutions
        ii. Process Modifications
    j. GOOD OPERATING PRACTICES
    k. REGULATORY INSPECTIONS
    l. INTRODUCTION
    m. TRENDS IN REGULATORY INSPECTIONS
    n. MANAGING REGULATORY INSPECTIONS
        i. SOP for Regulatory Inspections
        ii. Staff Training for Inspection
        iii. What Inspectors look for in a GMP Audit
        iv. Good Practices for Hosting Regulatory Inspections
        v. Inspections of Foreign Pharmaceutical Manufacturers
    o. INSPECTION OF QUALITY SYSTEMS/GMP AUDIT
        i. Records
        ii. Organization and Personnel
        iii. Buildings and Facilities
        iv. Equipment
        v. Storage of Raw and Packing Materials
        vi. Production and Process Controls
        vii. Packaging and Labeling
        viii. Laboratory Controls
        ix. Control Records
        x. Returned Drug Products
    p. INSPECTION OF TABLET/CAPSULE SECTION
        i. Raw Material Receipt and Granulation
        ii. Tablet Compression and Coating/Capsule Filling
    q. INSPECTION OF LIQUID ORALS SECTION
        i. Equipment
        ii. Compounding
        iii. Packaging
    r. INSPECTION OF TOPICAL PRODUCTS SECTION
        i. Manufacturing
        ii. Filling and Packaging
        iii. Cleaning
        iv. Microbiological Controls (Non-Sterile Topicals)
    s. INSPECTION OF STERILE PRODUCTS
        i. Facilities
        ii. Environment
        iii. Water for Injection
        iv. Sterilization
        v. Packaging
        vi. Personnel Practices
    t. INSPECTIONS OF QUALITY CONTROL LABORATORIES
        i. Out-of-Specification (OOS) Laboratory Results
        ii. Product Failures
        iii. Retesting
        iv. Resampling
        v. Averaging Results of Analysis
        vi. Microbiological
        vii. Laboratory Records and Documentation
        viii. Laboratory Standard Solutions
        ix. Methods Validation
        x. Equipment
        xi. In Process Controls and Specifications
        xii. Stability
        xiii. Computerized Laboratory Data Acquisition Systems
        xiv. Laboratory Management
    u. INSPECTION OF UTILITIES
        i. HVAC
        ii. Pharmaceutical Water System
        iii. Pharmaceutical Steam Systems
        iv. Compressed Air

References
Reference Data for Plant Managers
Index