Quality & Compliance

Certificates

KriSan Biotech obtains both the Taiwan Food and Drug Administration (TFDA) GMP certificate and the Japanese Accreditation of Foreign Manufacturers (AFM) certificate. We passed customer audits from many countries, including Taiwan, USA, Europe, Japan, Singapore, and the Middle East.

Quality System

KriSan’s Quality System follows the current ICH and cGMP guidelines, and we are committed to continual improvement, meeting the latest regulations, and fulfilling customer requirements. Our Quality System includes Materials Management, Production and In-process Control, Laboratory Control, Storage and Distribution, Change Control, Data Integrity, Contractor and Consultant Management, etc. The Pharmaceutical Quality System (PQS) ensures the quality and compliance with current Good Manufacturing Practices (cGMP) compliance throughout the lifecycle of the manufactured products at KriSan Biotech.