{ENGLISH} CHAPTER 2 HISTORY OF GMP AND INTERNATIONAL HARMONIZATION – PART 1

CHAPTER 2 HISTORY OF GMP AND INTERNATIONAL HARMONIZATION – PART 1

 

1. Birth of GMP

In 1938, the Food, Drug, and Cosmetic Act (FD&C Act) was passed in USA. In 1962, a major amendment to the FD&C Act was made to strengthen drug regulation. In 1963, cGMP (foundation of today’s GMP) was established. In 1968, WHO proposed GMP and recommended member countries to adopt it. In 1974, GMP was first introduced and became law in 1980.

 

2. GMP Hardware and Software

GMP includes GMP Software and Software. To implement GMP, it is essential to address, both the GMP software and GMP hardware.

GMP Software: Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Pharmaceuticals and Quasi-Drugs GMP Hardware: Regulations on Structures and Equipment of Pharmacies, etc.

 

3. The Original of GMP

“CGMP” originated in the U.S. After that, there were J-GMP, C-GMP, EU-GMP, PIC/S-GMP and C-GMP. “C” means “Current” – “The latest” GMP. The most important point is that GMPs should always be updated to reflect the latest conditions.

Besides that, there is also FFDCA (Federal Food, Drug, and Cosmetic Act), CFR (Code of Federal Regulation) and CGMP (Current Good Manufacturing Practice)

 

4. Three Principles of GMP

There are three principles of GMP to be complied to achieve constant supply of effective and safe pharmaceutical products

Firstly, to minimize human errors, including training of employees (understanding and record of SISPQ), prevention of the mistake by “Indication of status” and double checking (by more than 2 people or with computer system).

Secondly, it’s prevention of contamination and quality deterioration, including proper…