▣ GMP 소식

1) 2013년 상반기 의약품심사분야 자주묻는 질의응답집(FAQ) 발간

2013년 상반기 의약품심사분야 민원상담 내용 중 빈번한 질의답변 사례를 정리하여 의약품 개발 시 발생되는 궁금증을 해결하고, 심사자 및 개발자가 민원상담 내용을 서로 공유할 수 있도록 붙임과 같이 ‘의약품심사분야 자주묻는 질의응답집(2013년 상반기)’을 발간하오니 업무에 참고하시기 바랍니다. Continue reading

2) Warning Letters 2013

   These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) and CDER Headquarters Warning Letters (Ref. 1). Continue reading

 ▣ 가이드라인 소식

1) Current Good Manufacturing Practice for Combination Products   

   This document provides guidance to industry and FDA staff on the applicability of current good manufacturing practice provisions to combination products as defined under 21 CFR 3.2(e). Continue reading 

2) GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS - SECTION 2

Adequate identification of a donor is important to prevent cross donation at more than one plasmapheresis center, especially in areas where more than one center is located. The SOP should describe a system to prevent cross donations when applicable. Cross donation occurs when an individual donates at more than one plasmapheresis center or blood collection facility. Continue reading

▣ ISPE 국내, 외 소식