Overview:
In July 2021, Regulators in Japan announced they will start conducting inspections by surprise at facilities where drugs, pharmaceuticals and medical devices products are manufactured. The PMDA started their surprise inspections in August 2021.
Introduction
GMP Compliance Inspection concerning Drugs of Foreign Manufacturers is an inspection on the compliance of manufacturing control and quality control methods at the relevant manufacturing sites with Japanese GMP “Ministerial Ordinance 179: Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs” conducted by the Pharmaceuticals and Medical Devices Agency (“PMDA”). GMP compliance is a requirement for marketing approval.
Types of GMP Compliance Inspection
There are two types of GMP Compliance Inspection :
- Inspections that are conducted upon the application for new marketing approval or the application for partial changes of approved information
- Inspections that are conducted every five years following the obtainment of marketing approval
Surprise Facility Inspections:
GMP inspections are usually scheduled ahead of time and manufacturers were notified well in advance However, now there wouldn’t be any notification, as said by the Ministry of Health, Labor and welfare (MHLW) in July. In this case, manufacturers won’t be able to get ready and try to change anything prior to inspections if they don’t comply.
Regulators hope the implementation of surprise inspections will stop irregular activities, minimize risks associated with products and prevent misconduct on the part of manufacturers.
References
Ministerial Ordinance 179
Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs
Regulations for sale
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.