spacer
Saujanya books, indian books, books from india, tibetan books, tibetan texts, tibetan pecha, tibetan pechas, book store, bookstore, book shop, bookshop, book india, buy books online, online book store, online bookstore, buy books, books online, india book store, book from india, book shop india, bookshop in India, book seller in India, indian book store, online bookshop, wholesale book sellers, discount books store, indian authors books, online book store india, discount book seller, all subjects books, books from india, book publisher in india, online discount books, indian book seller, india books, book shopping, book distributor in India, wholesale book distributor
leftBar
rightBar
leftBar
rightBar
leftBar
rightBar
leftBar
rightBar
leftBar
rightBar
leftBar
rightBar
leftBar
rightBar

Welcome to www.saujanyabooks.com

spacer
 view Items
Total Title : 0
spacer
Sign In | Recommend Site
spacer
spacer
spacer
boxsearch
spacer
   
spacer
   
spacer
  Advanced Search
spacer
spacer
spacer
spacer
 
cards
spacer
 
 
 Book Details
arrow
spacer
spacer
Pharmaceutical Facility Management: The Plant Manager's Handbook (2nd Edition) / Kohli, J.P.S.
spacer
 
Pharmaceutical Facility Management: The Plant Manager's Handbook (2nd Edition)
Kohli, J.P.S.
 
  add
List Price : US$ 134.95
Our Price : US$ 107.96

You Save 20% + FREE DELIVERY WORLDWIDE
 
  recommend
spacer
 PRODUCT DETAILS
spacer
spacer
  Book ID : 25349
  ISBN-10 : 81-906467-9-6 / 8190646796
  ISBN-13 : 978-81-906467-9-6 / 9788190646796
  Place of Publication : Delhi
  Year of Publication : 2014
  Edition : (Second Edition)
  Language : English
  xvi, 408p., Figs., Tables, Index, 25 cm. (First Edition pub. in 2005)
   
spacer
 CONTENTS
spacer

CONTENTS:-

Preface
Preface to the First Edition

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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

spacer
spacer
 DESCRIPTION
spacer

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.

spacer
   
spacer
 
 
 

 

 

 
 
COPYRIGHT © 2001-2018, SAUJANYA BOOKS HOW TO ORDER I PAYMENTS I SITE MAP I FEEDBACK I LINKS I CONTACT US
Sitemap RSS Feed Sitemap    SAUJANYA BOOKS : 165-E, Kamla Nagar, Delhi - 110007 (INDIA)