{ENGLISH} CHAPTER 3 QUALITY SYSTEM AND GMP – PART 1

CHAPTER 3 QUALITY SYSTEM AND GMP – PART 1

1. Introduction

Quality control technology introduced by the U.S. in the postwar period. Japan has developed QC activities in the general industry and developed to TQM (Total Quality Management) in 1990s.

In the 1980s, the pharmaceutical industry entered an era of quality assurance that included process control, or “quality by design,” and GMP began to permeate the pharmaceutical industry. In the 2000s, the concept of quality management system was proposed by FDA, PIC/S, and ICH to further improve the quality assurance level of pharmaceutical products.

However, since the introduction of ICH Q9 and Q10, the methods of QC activities that have contributed to quality improvement of general industrial products have been incorporated into pharmaceuticals.

2. Harmonization of GMP with the Internationalization of Pharmaceuticals

The term GMP was coined in the U.S. in 1964, after the thalidomide incident that shock the world, and the term “quality of drug product” itself became a focus of attention. However, since each country introduced GMP separately and for their own reasons, even though the basic concept is the same, the detailed technical requirements may differ from country to country.  With the progress of globalization of pharmaceuticals, unification of GMPs has become desirable.

Two Streams of GMP Harmonization

The International Conference on Harmonization of Pharmaceutical Regulations in Japan, the United States, and Europe, or ICH, was launched with the aim of unifying the criteria for new drug approval review in each country, removing barriers to development and application for approval, and bringing better drugs to patients more quickly, and has been successful.

In…