Good Design Practices for GMP Pharmaceutical Facilities By Terry Jacobs, Andrew Signore

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Good Design Practices for GMP Pharmaceutical Facilities

Editor(s):

Terry Jacobs, Andrew Signore

Series:

Drugs and the Pharmaceutical Sciences

Published:

June 10, 2005 by CRC Press

Content:

576 Pages | 52 Illustrations

Features

This handbook

spans a wide range of topics central to the successful performance of pharmaceutical oral solid, sterile product, bioprocess, active pharma ingredient, clinical material, and regulated facilities

contains essential background information and solutions to common challenges in the layout and formation of manufacturing facilities that must comply with current codes, statutes, and regulations in industry

addresses emerging trends in process technology

contains practical suggestions that illustrate best practices in the planning and delivery of facilities that perform and conform to current regulatory requirements and business imperatives

enriches decision-making by emphasizing scope development, master planning, and clear design execution

Summary

A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

Pharmaceutical Industry Profile.
Current Good Manufacturing Practice.
Facility Planning. Architecture. Mechanical/HVAC/Utilities.
High Purity Water.
Automation and Process Controls.
Validation and Facility Design.
Process Engineering.
Oral Solid Dosage Facilities.
Sterile Manufacturing Facilities.
Biotechnology Facilities.
API Facilities.
Building Code Compliance.
Containment/Isolation.
Occupational Health and Safety.
Technology Transfer.
Environmental.
Support Laboratories.
Packaging/Warehousing