Manager (Information Products)
Allied Publishers Pvt Limited
751 Anna Salai, Chennai 600 002
alliedpublishers@vsnl.com
Editor(s): Bill Bennett and Graham Cole
Year: 2003 Price: £ 90
ISBN 0-85295-440-9 Number of Pages:460
Introduction
Regulatory Aspects
Introduction
Key Stages in Drug Approval Process
Example of Requirements
Post Marketing Evaluation
Procedures for Authorizing Medicinal Products in the
European Union
European and US Regulatory Perspectives
Good Manufacturing Practice
Introduction
GMP Design Requirements
GMP Reviews of Design
Validation
Introduction
Preliminary Activities
Validation Master Planning
Development of Qualification Protocol and Reports
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Handover and Process Optimization
Performance Qualification (PQ)
PRocess Validation (PV)
Cleaning Validation
Computer System Validation
Analytical Methods Validation
Change Control and Revalidation
Primary Production
Reaction
Key Unit Operations
Production Methods and Considerations
Principles for Layout of Bulk Production Facilities
Good Manufacturing Practice for BPC
Secondary Pharmaceutical Production
Products and Processes
Principles of Layout and Building Design
The Operating Environment
Containment Issues
Packaging Operations
Warehousing and Materials Handling
Automated Production Systems
Advanced Packaging Technologies
Safety, Health and Environment (SHE)
Introduction
SHE Management
Systems Approach to SHE
Inherent SHE
Risk Assessment
Pharmaceutical Industry SHE Hazards
Safety, Health and Environment Legislation
Design of Utilities and Services
Introduction
Objectives
Current Good Manufacturing Practice
Design
Utility and Service System Design
Sizing of Systems for Batch Production
Solids Transfer
Cleaning Systems
Effluent Treatment and Waste Minimization
General Engineering Practice Requirements
Installation
In-House Versus Contractors
Planned and Preventive Maintenance
The Future?
Laboratory Design
Introduction
Planning a Laboratory
Furniture Design
Fume Cupboards
Extraction Hoods
Utility Services
Fume Extraction
Air Flow Systems
Safety and Containment
Process Development Facilities and Pilot Plants
Introduction
Primary and Secondary Processing
Process Development
Small-Scale Pilot Facilities
Chemical Synthesis Pilot Plants
Physical Manipulation Pilot Plants
Final Formulation, Filling and Packing Pilot Plants
Safety, Health and Environmental Reviews
Dispensaries
Optimization
Commissioning and Validation Management
Pilot Manufacturing Facilities for the Development and Manufacture of Bio-Pharmaceutical Products
Introduction
Regulatory, Design and Operating Considerations
Primary Production
Secondary Production
Design of Facilities and Equipment
Process Utilities and Services
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Please Send Your Order to:
R Krishnan
Manager (Information Products)
Allied Publishers Pvt Limited
751 Anna Salai, Chennai 600 002
alliedpublishers@vsnl.com