1 Pharmaceutical Industry Profile Andrew A. Signore CONTENTS Industry Overview: Introduction Outsourcing Contract Development and Manufacturing Supply Chain Logistics and Security Risk Management Strategic Environmental Forces Political Forces Social Forces…
11 Sterile Manufacturing Facilities George Wiker CONTENTS Introduction Executive Summary Injectable Products Understanding the Principles of Sterile and Aseptic Sterile Manufacturing Facilities Process Technologies Drug Product Processing Primary Drug Product…
12 Biotechnology Facilities David M. Marks, PE CONTENTS Introduction Executive Summary Overview Historical Context Key Concepts and Principles Definitions Biotechnology Facility Design Production Systems Bioprocess Manufacturing Operations Equipment Cleaning and…
15 Occupational Health and Safety George Petroka CIH, CSP CONTENTS Introduction Occupational Health and Safety Management Accident Prevention Signs and Tags Accident Prevention Signs Accident Prevention Tags Combustible Dust Review…
10 Continuous Oral Solid DoseProcessing Michael Rooney CONTENTS Introduction Executive Summary Overview of Continuous Granulation Batch Processing Technologies and Improvements Continuous Granulation Continuous Granulation versus Batch Processing Equipment Requirements Facility…
16 Sustainability Asif Syed CONTENTS Introduction Issues in Sustainability Air Quality and Emissions Environment Release of Products Water Solid Waste Energy Sustainable and High-Performance Facilities Integrated Product Design Sustainable Assessment…
9 Oral Solid Dosage Facilities Edward J. Tannebaum, AIA and Samuel Halaby CONTENTS Introduction Meeting Industry and Market Needs Regulatory Challenges Manufacturing Processes Drug Delivery Technologies Regulatory Pressures on OSD…
6 High-Purity Water Gary V. Zoccolante CONTENTS Introduction Executive Summary Good Manufacturing Practices Pharmacopeia Groups Water Quality Requirements Sampling Validation, Verification, and Qualification Related Reading Monograph Requirements Water Quality Selection…
8 Process Engineering Art Meisch CONTENTS Introduction Role of Process Engineering in the Pharmaceutical Industry Relationship of Process Engineering to Other Design Disciplines Impact of cGMPs on Process Engineering Executive…
17 QA/QC Laboratories and Related Support Spaces Cassidy Hobbs, AIA CONTENTS Introduction Executive Summary QA/QC Labs Laboratory Planning Process Problem Seeking Data Gathering Space Programming Analysis Problem Solving Laboratory Components…
