This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products.

This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics.

Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.

chapter 1|3 pages

Milling and Charging

chapter 2|4 pages


chapter 3|10 pages


chapter 4|2 pages


chapter 5|8 pages

Membrane Coating

chapter 6|5 pages


chapter 7|2 pages


chapter 8|4 pages


chapter 9|4 pages


chapter 10|3 pages

Sorting and Packing

chapter 11|5 pages

Capsule Filling

chapter 12|23 pages

Safe Handling of APIs and Drugs

chapter 13|4 pages

Data Integrity Compliance

chapter 14|11 pages

Guidelines for Statistical Procedure

chapter 15|10 pages


chapter 16|9 pages

Clean-In-Place (CIP) Systems

chapter 17|11 pages

Cleaning Validation

chapter 18|7 pages

Manufacturing Process Validation

chapter 19|14 pages

Risk-Based Life Cycle Management

chapter 20|3 pages

pFMEA Manufacturing Procedure