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.
Preface
Chapter 1 : Milling & Charging
Chapter 2 : Granulation
Chapter 3 : Compression
Chapter 4 : Sub-Coating
Chapter 5 : Membrane Coating
Chapter 6 : Drilling
Chapter 7 : Drying
Chapter 8 : Overcoating
Chapter 9 : Printing
Chapter 10 : Sorting & Packing
Chapter 11 : Capsule filling
Chapter 12 : Safe Handling of API & Drugs
Chapter 13 : Data Integrity Compliance
Chapter 14 : Guidelines for Statistical Procedure
Chapter 15 : Calibration
Chapter 16 : Clean-In-Place
Chapter 17 : Cleaning Validation
Chapter 18 : Manufacturing Process Validation
Chapter 19 : Risk Based Life Cycle Management
Chapter 20 : pFMEA Manufacturing Procedure
Chapter 21 : Analytical Methods Development, Validation, and Transfer
Appendices
Index
