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…
INTRODUCTION This chapter provides an overview of the regulatory requirements of current Good Manufacturing Practices (cGMPs) and describes the importance of cGMPs when designing engineering processes within a pharmaceutical facility….
5 Facility Utility Systems Jack C. Chu, Leonid Shnayder, and Joe Maida CONTENTS Introduction Production Facility and Utility Systems Design Must Follow GMP Practice Key Concepts Executive Summary Integrated Approach…
14 Containment Technology Hank Rahe and Brian G. Ward CONTENTS Introduction Defining Drugs in Terms of Contamination Risk Communication of Risk Risk Assessment by NIOSH and the European Medicines Agency…
18 Packaging and Warehousing John S. Holton CONTENTS Introduction Packaging Defined Importance of Packaging Packaging Functions Contain Function Protect and Preserve Function Transport Function Inform and Sell Function Levels of…
7 Commissioning, Qualification, and Validation Christina Meyer Dell Cioppia CONTENTS Introduction Executive Summary History of Validation Quality by Design Good Engineering Practice Project and Engineering Change Control Project Life Cycle…
13 Codes and Standards Eric Bohn CONTENTS Introduction Executive Summary Key Concepts Historical Background Zoning Codes Building Codes Other Standards Code Interpretation Role of the Design Professional Role of the…
