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Pharmaceutical Engineering Handbook
from C.H.I.P.S.

Pharmaceutical Engineering Change Control

Second Edition
edited by Simon G. Turner


Features of Pharmaceutical Engineering Change Control, 2nd edition:

  • Examines the basis for developing change control procedures for pharmaceutical projects
  • Discusses the importance of integrating change control into quality management systems
  • Explores the role computers play in the production of pharmaceuticals
  • Covers how to ensure change controls are effectively applied and recorded
  • Contains case histories that illustrate key points and provide a basis for change control training

While change control can ensure that developments do not compromise business operations, when dealing with pharmaceuticals manufacturing, change control must also ensure that developments do not compromise regulatory compliance. Pharmaceutical Engineering Change Control, Second Edition gives you the technical and management skills required to successfully and efficiently employ change control procedures.

Contents

Change is Inevitable - Why?

  • Objective
  • The Economics
  • The Regulatory Demands with Particular Regard to Healthcare Manufacturing Regulations
  • Changes in Good Manufacturing Practice
  • Changes during Design
  • Changes in Software
  • National or Governmental Demands of Industry in General
  • Maintenance
  • Date-Related Functions

Regulation of Change Control for Drugs and Biologics

  • Risks of Noncompliance: Auditing and Documentation
  • Current Regulations and Guidance for Evaluating and
  • Reporting Manufacturing Changes to the FDA
  • Moving Forward in Managing Change

A Regulatory View (EU)

  • Brief History and Recent Developments
  • The Change to Mutual Recognition Agreements
  • How the Change to MRAs Could Affect You
  • Future Changes - The Increasing Scope of GMP
  • Notification Procedures, Forms and Documents
  • Transmissible Spongiform Encephalopathy (TSE) and Regulatory Controls
  • Manufacturers Licenses
  • Validation, Revalidation and All That Is Entailed
  • Maintaining Compliance and Auditing

The Operational Phase

  • Control Requires Documentation
  • Preventive Maintenance
  • One System for All
  • Permit-to-Work System
  • Traceability
  • Reasons For Change
  • Documentation Changes
  • Auditing the Change Control System

The Change Control System

  • Background
  • Functions of the Change Control System
  • Types of Change
  • Pitfalls and Problems
  • The Change Control Forms
  • Administration and Auditing

Change Control and Computer Systems

  • Objective
  • Change and Computers III. Change Control - Basics
  • Computer System Elements and the Operating Environment
  • Considering the Consequences of Change
  • Change Control in Practice
  • What Can Go Wrong
  • Auditing Computer Systems

Case Histories and Anecdotes

  • Explosion in a New Solvent Tank
  • Washing, Cleaning, Sterilizing, and Purging Operations
  • Vessel Agitator Position Modification
  • Room Collapse during Commissioning
  • Autoclave Upgrade
  • Lactose - California vs. Wisconsin
  • Asthma Inhaler Cartridges Scrapped
  • Increase in Demand on Site Steam
  • Uncontrolled Drawing
  • Plant Labeling Inconsistency
  • Cheaper Cleaning Materials
  • Batch Records Inaccurate
  • Gardener's Hut
  • The Effect of Process Tweaks over Time
  • Climb in Product Yield
  • Change to Emergency Exit Could Have Been Disastrous
  • Water for Injection System Contamination
  • Room Clearance Failure
  • Drain Valve Opened by Mistake
  • Increase in Compressed Air Capacity
  • Thalidomide
  • Southern Corn Leaf Blight
  • The Great Cranberry Scare
  • The Cyclamate Affair
  • Anecdotes and Quotes

Projects

  • What to Control on Projects
  • Project Attributes
  • Project Change Control Procedure - What Should It Cover?
  • Responsibilities
  • Methodology
  • Change Flag Generation
  • Approvals
  • Change Logging and Monitoring of Approvals

Index

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Pharmaceutical Engineering Change Control
Second Edition
edited by Simon G. Turner

200 pages $248.95 + shipping
Texas residents please add 6.75 % sales tax

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