{ENGLISH} CHAPTER 2 HISTORY OF GMP AND INTERNATIONAL HARMONIZATION – PART 2 (END)

CHAPTER 2 HISTORY OF GMP AND INTERNATIONAL HARMONIZATION – PART 2 (END)

 

6. PIC/S to become a Global Standard

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.

In 1970, the year after WHO recommended the adoption of GMP, the Pharmaceutical Inspection Convention (PIC) was established in Europe. The problem was the countries outside the EU could not join the PIC. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995． PIC/S works to establish a network among participating authorities, maintain mutual trust, exchange information, accumulate knowledge in GMP-related fields, and provide mutual training for inspectors, as well as to develop GMP standards and various guidelines. The PIC/S GMP Guide is becoming global standard as the number of member authorities expands, since member authorities are required to use PIC/S GMP as the basis for GMP inspections and manufacturing licenses. PIC/S GMP is derived from EU GMP, and when EU GMP is revised, it is usually reflected in PIC/S GMP as well.

 

Narrow focus on GMP and regulatory agencies. Has a GMP Guideline (fully aligned with EU GMP). Publishes additional guides for inspectors. DOES NOT do inspections. Assesses the competence of inspectorate agencies.

The need for Japan to become a member of PIC/S, because,

to ensure the safety of the Japanese people with pharmaceutical products that meet global GMP standards to secure the position of the Japanese pharmaceutical industry in the global market to increase the efficiency of resources required for inspections.

The PMDA (for GMP inspections), and prefectural governments operate under the same quality system, and a coordinating organization…