Pharmaceutical Facility Management

About Book

ISBN 9788190646796
Presentation Hardbound, 424 Pages
Edition 2nd Edition 2017
Weight 1.25 Kg
Author JPS Kohli
Price USD 125
Availability In Stock

The new second edition of this bestselling book is bigger, better and takes the reader to the next level and future ready. While the earlier edition was all about smooth and troublefree working of a pharmaceutical facility, the new second edition strives to achieve excellence and set industry benchmarks for facilities of the future. The pharmaceutical facilities of today must reach out beyond the routine and strive for excellence in all spheres of activity, to enable the company retain its competitive edge in the marketplace. To put the facility manager firmly in control of the entire facility, a new chapter has been created specifically to focus on facility manager and the roles and responsibilities that compose the job description of this position.

 

Social responsibility towards the planet we inhabit has been recognized as our unfailing duty and ways to sustain the ecosystem are constantly being evolved. Since pharmaceutical manufacturing facilities impose lots of demands on the physical environment in which they exist, innovative companies are always trying to lessen their carbon footprint through various methodologies being evolved. What is today seen as innovation will perhaps become mandatory in the near future and hence a new chapter has been introduced called ‘Sustainable Facilities’ that suggests various means by which a company can reduce its carbon footprint.

 

The most exciting change however in the new edition is the introduction of a new chapter, 'Operational Excellence in Pharma Manufacturing' which focuses on manufacturing efficiency for the first time, focusing on actual shop floor strategies rather than arcane management fuzzy logic formulas. While current efficiency levels in the pharmaceutical industry are examined, avenues for excellence are explored that include continuous processing of pharmaceuticals, automated manufacturing, optimizing batch sizes and cycle times and overall equipment effectiveness (OEE). A company can thus develop its own corporate manufacturing strategy based on the technology level it is willing to upgrade to, market and business demands and the resources required for such project.

 

All other chapters have been thoroughly overhauled, outdated information removed and current and up-to-date information included to transform the existing chapters to cutting edge contemporary standards.

 

About the Author

 

JPS 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.

He is a member of Indian Pharmaceutical Association (IPA), Indian Pharmacy Graduates Association (IPGA), Indian Hospital Pharmacists Association (IHPA), International Society of Pharmaceutical Engineers (ISPE), American Association of Pharmaceutical Scientists (AAPS), Pharmaceutical and Healthcare Sciences Society (PHSS) and International Federation of Pharmaceuticals (FIP). He is included in Who's Who in the field of Science and Engineering. He has travelled extensively and visited/audited the manufacturing plants of many companies. He now heads the firm Business Horizons that specializes in books on pharmaceuticals and herbal medicines with an emphasis on technical and quality aspects. He is a third generation pharmacist in his family, loves to travel and lives in New Delhi.

CONTENTS

Preface

Preface to the First Edition

MANAGING PHARMACEUTICAL FACILITIES

Introduction

Role of a Facility Manager

Financial Management

Facilities Condition Assessment (Audit)

Pharmaceutical Facility Validation

    Facility Design Qualification

    Facility Installation Qualification

    Facility Operational Qualification

Utility Systems

Safety for Facility Management

 

SUSTAINABLE FACILITIES

Ecosystems

Sustainable Manufacturing

Current Scenario

Green Chemistry

    Process Mass Intensity

    Green Solvents

Green Engineering

    Sustainable Buildings

    Sustainable Energy Management

        Cleanrooms (HVAC)

        Facility Lighting

        Electric Motors

        Compressed Air

        Boilers

    Sustainable Water Management

 

OPERATIONAL EXCELLENCE IN PHARMA MANUFACTURING

Introduction

Focus on Manufacturing Efficiency

Current Efficiency Levels

Continuous Processing of Pharmaceuticals

Automated Manufacturing

Good Automated Manufacturing Practices (GAMP)

ASTM E2500

Optimizing Batch Sizes and Cycle Times

Overall Equipment Effectiveness

Corporate Manufacturing Strategy

 

PRODUCTION ISSUES

Tablets/Capsules

    Introduction

    Blenders

    Dryers

    Tablet and Capsule Equipment

    Granulation Mix Analysis

    In Process Testing

    Process Notes

    Common Problems in Tabletting

Liquid Orals

    Process Notes

Topical Preparations

    Potency Uniformity

    Equipment and Production Control

    Preservatives Used in Topical Preparations

    Preservatives Used in Ophthalmic Preparations

Pharmaceutical Water Systems

    System Validation

    Microbial Limits

    Water for Injection Systems

    Purified Water Systems

 

EQUIPMENT CLEANING AND MAINTENANCE

Introduction

Maintenance Methodologies

Lean Maintenance

Calibration of Equipment

Procedure

Calibration Program

Calibration Standards

Calibration Procedures

Instrument Maintenance Records

Calibration Instruments

Electric Motors

Basic guidelines

Motor Repair / Replacement Decisions

Economic Comparison

Centrifugal Pumps

Fluid Bed Dryer

Mass Mixer

Multimill

Planetary Mixer

High Shear Mixer Granulator (Rapid Mixer Granulator)

Sifter

Tray Dryer

Wurster Coater Dryer

Double Cone Blender

Tablet Compression Machine

Inspection and Maintenance of Compression Tooling

Common Problems Encountered with Tablet Tooling

Vibratory Tablet De-Duster

Conventional Coating Pan

Polishing Pan

Strip Sealing Machine

Capsule Autoloader

Capsule Inspection Cum Polishing Machine

Dry Syrup Powder Filling Machine

Capsule Filling Machine (Manual)

Capsule Filling Machine (Semi-Automatic)

Tanks, Accessories, Utensils And Stirrers

Filter Press

Liquid Oral Filling Machine

Bottle Labeling Machine

Component Preparation Tank

Melting Tank

Ointment Mixer (Silverson Type)

Ointment Bulk Storage Drum

Tube Filling Machine

Equipment For Sterile Products (General)

Sterile Product Vessels

Stirrer

Vials /Ampoules Washing Machine

Rubber Stopper Washing Machine

Membrane Filter Holder

Filtration Tubing

Ampoule Filling And Sealing Machine

Vial /Ampoule Filling Assemblies And Accessories

Autoclave

    Preventive Maintenance

Vial Sealing Machine

Vial/Ampoule Inspection Machine

Compressed Air

Boiler

The Boiler Room

Piping Systems

Steam Traps

Water Treatment

Pumps

The Venting System

The Boiler

Test Firing

HVAC/R

Fans

Air-Handling Unit

Chillers and Condensers

Cooling Towers

Ducts Cleaning

Clean Room Monitoring

Safety Tips for HVAC Maintenance

Pharmaceutical Water

Cleaning of Piping

Passivation

Sanitization

Setting up a Machine Shop

    Guidelines and Suggestions

    Safety

    Maintenance

    Regulatory and Compliance Issues

 

COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM

Introduction

Computerized Maintenance Management Systems (CMMS)

Advantages of CMMS

Guidelines for Small Companies

Implementation of CMMS

Implementation Basics

Framework for Transition

Preventive Maintenance

Continuous Process

Automatic Data Collection

Elements of CMMS

Work Order

Assets

Location

Preventive

Employee

Masters

Reports

Work Orders

How to Open a New Work Order

Filter Out Work Order Information

Close a Work Order

Add Labour in the Work Order

Direct Issue in a Work Order

View Total Cost of a Work Order

Assets

Add a New Asset

How to Filter out Assets Information

Add a New Location

Filter Out Location Information

Employee/Requester

Add a New Employee/Requester

Filter Out Employee/Requester Information

Preventive Maintenance

Register a New PM Task

Filter Preventive Maintenance Schedules

Generate PM Work Orders

Masters

Department

Failure Code

Assets Category

Suppliers/Contractors

Reports

 

WORK ENVIRONMENT AND SAFETY

Housekeeping

Introduction

Capsule Department

Tablet Department

Liquid Oral Department

Ointment Department

Sterile Area

Raw, Packing and Finished Goods Stores

Pest Control And Disinfection

Managing Older Buildings

Roofing Maintenance

Indoor Air Quality

Disaster Management

Planning For an Emergency

Damage Control

Safety

Safety Audits

Pharmaceutical Hazardous Areas

Safety Procedures

Safety Management through Air Handling Systems

Fire Detection and Control

Hazards Specific to Pharmaceutical Industry

Pharmaceutical Manufacturing Precautions

Personal Protective Equipment

Electrical Safety

Electrical Safety Regulations and Standards

Electrical Safety Program

Electrical Hazards

Work Procedures, Tools and PPE

Safety by Design

First Aid

Facility Security

 

TRAINING

Introduction

Writing a Training Program

Structure of Training Programs

Conducting Training Sessions

Class

Objectives

Material

Props

Lesson Plan

Environment

Training Pointers

Tips To Become a Better Trainer

Presentation Skills

Body Language

The Role of Questions

Assessment

Documentation of Training

A Case Study

Sample Training Programs

Training Program for Supervisors

Training Program for Workmen

Training Program for Clean Room

Training Program for Autoclave

Training Program for Dry Heat Sterilizer

Training Program for Janitors

Training Program for Laminar Air-Flow

Training Program for Membrane Filter Holder

Training Program for Personal Hygiene

Training Program for Production Supervisor

Training Program for Sterile Stoppering

Training Program for Workmen

 

VALIDATION

Introduction

Purpose of Validation and Qualification

Responsibility for Validation and Qualification

Validation Master Plan

Purpose

Format and Content

Installation and Operational Qualification

Introduction

Installation Qualification (lQ)

Operational Qualification (OQ)

Re-Qualification

Non-Sterile Process Validation

Introduction

Prospective Validation

Concurrent Validation

Retrospective Validation

Re-validation

Change Control

Cleaning Validation

Introduction

Documentation

Sample Formats

Format for an installation qualification protocol

Format for an operational qualification protocol

Format for a performance qualification protocol

Examples of IQ, OQ, and PQ Protocols

Content Requirements for Equipment/Systems

Water for Injection

Temperature Controlled Equipment

Centrifuges

Blenders, mixers and homogenizers

Pumps

Backup Power Generator

Controlled Air Equipment

Measuring Apparatus

Filter for Integrity Testing Apparatus

Format for a Process Validation Protocol

Validation Protocols

 

ENVIRONMENTAL MONITORING

Introduction

Pharmaceutical Products

Botanicals

Pharmaceutical Preparations

Diagnostic Substances

Biological Products

Industrial Processes In The Pharmaceutical Industry

Research and Development

Production of Bulk Pharmaceutical Chemicals

Chemical Synthesis

Natural Product Extraction

Fermentation

Formulation into Final Dosage Forms

Raw Material Inputs And Pollutant Outputs

Air Pollution

Bulk Manufacturing

Formulation

Air Pollution Control Equipment

Condensers

Scrubbers

Combustion or Incineration

Adsorption

Wastewater

Solid Wastes

Pollution Prevention

Material Substitutions

Process Modifications

Good Operating Practices

 

REGULATORY INSPECTIONS

Introduction

Trends In Regulatory Inspections

Managing Regulatory Inspections

SOP for Regulatory Inspections

Staff Training for Inspection

What Inspectors look for in a GMP Audit

Good Practices for Hosting Regulatory Inspections

Inspections of Foreign Pharmaceutical Manufacturers

Inspection of Quality Systems/GMP Audit

Records

Organization and Personnel

Buildings and Facilities

Equipment

Storage of Raw and Packing Materials

Production and Process Controls

    Critical Manufacturing Steps

    Equipment Identification

    In-Process Testing

Packaging and Labeling

Laboratory Controls

Control Records

Returned Drug Products

Inspection Of Tablet/Capsule Section

Raw Material Receipt and Granulation

Tablet Compression and Coating/Capsule Filling

Inspection of Liquid Orals Section

Equipment

Compounding

Packaging

Inspection of Topical Products Section

Manufacturing

Filling and Packaging

Cleaning

Microbiological Controls (Non-Sterile Topicals)

Inspection of Sterile Products

Facilities

Environment

Equipment

Water for Injection

Sterilization

Packaging

Personnel Practices

Inspections of Quality Control Laboratories

Out-of-Specification (OOS) Laboratory Results

    Laboratory Errors

    Laboratory Investigations

    Formal Investigations

    Investigation Documentation

Product Failures

Retesting

Resampling

Averaging Results of Analysis

Microbiological

Laboratory Records and Documentation

Laboratory Standard Solutions

Methods Validation

Equipment

In Process Controls and Specifications

Stability

Computerized Laboratory Data Acquisition Systems

Laboratory Management

Inspection of Utilities

HVAC

Pharmaceutical Water System

Pharmaceutical Steam Systems

Compressed Air

 

References

Reference Data for Plant Managers

Index


New User?

Bookseller?