Part 1: Pharmaceutical Manufacturing Management

Chapter 1: Overview of GMP and International Harmonization

Chapter 2 Laws and Regulations Related to Pharmaceutical Manufacturing

Chapter 3 Pharmaceutical Manufacturing and Quality Control

Chapter 4 Manufacturing and Change Management of Pharmaceutical Preparations

Chapter 5: Improving Quality Based on Pharmaceutical Design

Chapter 6: Overview of Validation

Chapter 7 Process Validation

Chapter 8 Sterilization Validation

Chapter 9 Qualification of Manufacturing Water and Air Conditioning Systems

Chapter 10: Validation and Verification of the Washing Process

Chapter 11 Validation of Biopharmaceuticals



Part 2 Pharmaceutical Quality Control

Chapter 1: Introduction to Quality Control

Chapter 2 Pharmaceutical Quality Standards and Common Rules

Chapter 3 Statistical Analysis of Data

Chapter 4 Laboratory Management and Common Test Methods

Chapter 5 Quality Control of Raw Materials

Chapter 6: Process Quality Control During Pharmaceutical Manufacturing

Chapter 7 Quality Control of Finished Pharmaceutical Products

Chapter 8: Practice of Pharmaceutical Quality Control

Chapter 9 Quality Assurance of Pharmaceuticals

Chapter 10: Test Method Validation

Chapter 11 Drug Development and Approval

preface

The field of manufacturing and quality control of pharmaceuticals is the ultimate academic and technical field that can consistently guarantee the quality and performance of prescription and over-the-counter drugs supplied to the medical field and the market, and therefore plays a crucial role in ensuring that not only healthcare professionals but also all citizens can safely consume and handle pharmaceuticals.
Since March 2011, the six-year pharmacy school system has been implemented nationwide, and as the global quality level of pharmaceuticals has rapidly improved due to the mutual recognition system of GMP among countries, the advancement of GMP in Korean pharmaceutical companies has also accelerated. Therefore, in order to strengthen the job competencies of pharmacists, it has been required to operate an educational course in the fields of pharmaceutical manufacturing and quality control.
In response to this, our division compiled two booklets, “Pharmaceutical Quality Science” and “Pharmaceutical Manufacturing Management,” in February 2013, and, reflecting the latest regulations, “Pharmaceutical Quality Science, 5th Edition” and “Pharmaceutical Manufacturing Management, Revised Edition” were published in 2022.

These booklets are designed to enable pharmacy students and practitioners in related fields to systematically learn and apply knowledge of pharmaceutical manufacturing and quality control. They include GMP standards, unit operations, manufacturing processes by formulation, laboratory management, various common quality assessment test methods, quality assessment test cases for raw materials and preparations, quality assurance, statistical techniques, etc., and include recent regulatory trends in manufacturing and quality science.

The content and knowledge system of these books are extensive, and to enhance students' understanding and learning effectiveness, the 3rd edition of "Pharmaceutical Manufacturing and Quality Control Practice" was published in 2020.
Part 1 of this exercise covers the content of pharmaceutical manufacturing management, and Part 2 covers the content of pharmaceutical quality science. Each chapter includes a summary, short answer questions, and true or false questions.
As of 2022, the 4th edition has been published, maintaining the structure of the 3rd edition while more faithfully reflecting the core contents and supplementing the practice problems.
We hope that this booklet will be widely used by students studying pharmaceutical manufacturing and quality as well as those working in the field.