SOP Guidelines - Hardcover

D. H. Shah

Hardcover

ISBN 10: 8190078887 ISBN 13: 9788190078887

Publisher: Business Horizons, 2007

Synopsis

Introducing the Second Edition of our bestselling book, the new edition is now a comprehensive and cutting-edge guide to preparation and management of Standard Operating Procedures. It covers the fields of Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping. Contains actual full text SOPs that can be inorporated directly in your systems and modified as required. It includes for the first time, detailed and easy to understand methods of developing SOPs that are required by the manufacturer and regulatory agencies. Electronic SOP management systems and their desired structures are covered. Also included in the new edition are various systems of Electronic Batch Records and pharmaceutical ERP systems and their management. CONTENTS Introduction Preface to the1st Edition DESIGNING EFFECTIVE SOPs Introduction and Purpose of SOPs Benefits of SOPs Types of SOPs Contents of a Typical SOP Level of Detail Writing Style SOP Development Create/Edit Review Approve Publish Distribute Archive SOP Format Title Page Table of Contents Text Transition to Electronic SOPs Too Many Documents Over-complex Documents Inappropriate Format Management Systems Advantages of Electronic SOPs System Requirements Structure of eSOP System Audit Critical Activities Authenticate Users Keep Track of Who Has Seen What Validation Support Future of eSOP ELECTRONIC MANUFACTURING eMANUFACTURING Understanding the e in the eManufacturing Electronic Records Requirements for Electronic Records Risk Based Approach to Future Purpose of eManufacturing Introduction to Electronic Batch Records (EBR) Benefits of Electronic Batch Records (EBR) Plant Efficiencies Impact of QC Lab on Batch Cycle Time Management of Manufacturing Data User Requirement Specification (URS) Vendor Selection Qualification and Validation of Software Evolution from Paper to EBR Features of cGMP Compliant EBR System Process Historian for Management of Manufacturing Data Enterprise Resource Plan

About this title

About the Author

D. H. Shah graduated in pharmacy in 1962 and in the last 40 years has been actively associated with manufacture of all categories of drug formulations. He is presently Technical Director with a few reputed pharmaceutical companies and is involved in quality assurance and GMP compliance activities.

About this edition

• Publisher: Business Horizons
• Publication date: 2007
• ISBN 10: 8190078887
• ISBN 13: 9788190078887
• Binding: Hardcover
• Language: English
• Edition number: 2
• Number of pages: 464