A Progress Report on GMP Certification for Radiopharmaceuticals with PIC/S Membership (Korea)

After the Ministry of Food and Drug Safety joined PIC/S in 2014, local rules and guidelines for the pharmaceutical industry were raised to meet PIC/S standards. Radiopharmaceuticals and three other groups of drugs that were excluded from good manufacturing practices began to be regulated by law. Since then, hospitals and manufacturers have exerted significant efforts to attain GMP certification, and five manufactories have been certified to date. Radiopharmaceutical manufacturers and medical professionals in nuclear medicine departments at hospitals are now aware of the importance of GMP. 

However, there has been a lack of documentation on why radiopharmaceuticals require GMP certification, and what preparations are needed to receive GMP certification. The Ministry of Food and Drug Safety has provided guidelines, held two briefing sessions, and published a set of related questions and answers. Such materials were merely Korean translations of PIC/S regulations, introduction of laws in developed countries, and a summary of Q&As from the briefing sessions. Against this backdrop, this issue paper examines the background of GMP certification for radiopharmaceuticals, preparations for GMP certification, and preparations for re-certification after three years.

You can read the full text at: http://www.ratis.or.kr/ratis/ezpdf/customLayout.jsp?contentId=QzovcmF0aXNfc3RvcmFnZS91cGxvYWQvXFJUXzIwMTcxMTE1MTAzNzI5NTY3