The Ministery of Food and Drug Safety said on the 20th that the "GMP regulatory harmonization consultation (hotline)" established with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) to support the domestic pharmaceutical industry's implementation of global Good Manufacturing Practice (GMP) standards has been fully launched.
This hotline was prepared in March as part of the "Global GMP implementation technology support consultative body," composed of the Ministery of Food and Drug Safety, the pharmaceutical-bio association, and industry experts. It is a communication channel to respond quickly to difficulties and inquiries that the industry encounters while applying global GMP standards.
Pharmaceutical companies can submit GMP-related inquiries and suggestions at any time via the pharmaceutical-bio association's website or a dedicated phone line. The Ministery of Food and Drug Safety will review the submissions and provide responses, and matters requiring additional technical support will be placed on the consultative body's agenda to discuss practical application measures with experts.
The consultative body operates three subcommittees: ▲ measures to apply PUPSIT (pre-use post-sterilization integrity test) ▲ measures to apply barrier technology for lyophilization ▲ GMP pending issues. On-site experts from the pharmaceutical industry are participating to discuss stable implementation of global GMP standards and on-site application measures.
A Ministery of Food and Drug Safety official said, "We expect this hotline to serve as a channel to quickly identify what is needed in the industry's process of implementing GMP standards and to prepare practical support measures through expert discussions," adding, "We will continue to expand communication with the field to support the domestic pharmaceutical industry in stably implementing global GMP standards."