For the first time, regulators in Japan are carrying out surprise inspections at facilities where pharmaceutical and medical device products are manufactured. The inspections, which began in August, are designed to improve Japan’s system for ensuring the products are consistently produced according to high-quality standards.
The announcement that the Good Manufacturing Practice (GMP) inspections, previously scheduled with manufacturers in advance, would NOW generally take place without prior notification, was made by the Ministry of Health, Labor and Welfare (MHLW) on July 28. It is designed to block irregular activities, minimize risks associated with products and prevent misconduct on the part of manufacturers. In most cases going forward, no notification will be given when an inspection will occur, nor on the products or documents to be inspected.