Design of GMP compliance radiopharmaceutical production facility inMINT

摘要

In 1985, MINT built the only radiopharmaceutical production facility in Malaysia. The facility wasrndesigned based on International Atomic Energy Agency (IAEA) standard guidelines, which provides radiationrnsafety to the operator and the sorrounding environment from radioactive contamination. In 1999, MalaysiarnNational Pharmaceutical Control Bureau (NPCB) enforced the guidelines from Pharmaceutical InspectionrnConvention Scheme (PICS) to meet the requirements of the Good Manufacturing Practise (GMP) forrnpharmaceutical products. Among others, the guidelines require the pharmaceutical production facility to berndesigned based on cleanroom environment. In order to meet the requirement, the design of a radiopharmaceuticalrnproduction facility shall combine the concept of radiation safety and cleanroom to ensure both, requirementsrnfrom GMP and recommendations from IAEA are met. This design requirement is necessary to ensure arnradiopharmaceutical production facility which is safe, has high production quality and in compliance with thernMalaysian and International standards.