edited by Andrew Signore and Terry Jacobs
Features of Good Design Practices for GMP Pharmaceutical Facilities:
- 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
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.
Contents
- 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
Index
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