▣ GMP 소식

1) 「의약품동등성시험기준」일부개정고시안 행정예고

   식품의약품안전처 공고 제2013 - 80호

생물학적동등성시험(이하 “생동성시험”이라 한다) 실시 시 피험자 내 흡수율의 상당한 차이로 생동성시험의 재현성 확보에 어려움이 있는 의약품의 경우 의약품의 특성에 맞게 평가기준을 정비하고, 치료영역이 좁은 성분에 대한 기준과 원료약품 및 분량의 변경 시 변경수준을 정하는 기준을 명확히 하며, 생동성시험 결과보고 시 신청의약품의 동등성 평가에 불필요한 자료의 제출의무를 폐지하는 등 의약품동등성 시험 기준 및 운영에 적정을 기하고자 함. Continue reading

2) Vaccines, Blood & Biologics

   Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
This guidance, when finalized, will supersede the guidance of the same title dated July 2001 (July 2001 Guidance) announced in the Federal Register of August 7, 2001 (66 FR 41247) (Ref. 1). Continue reading

 ▣ 가이드라인 소식

1) Computerized Systems Used in Clinical Investigations   

   There is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject. Such electronic source data and source documentation must meet the same fundamental elements of data quality (e.g.,attributable, legible, contemporaneous, original,5 and accurate) that are expected of paper records and must comply with all applicable statutory and regulatory requirements. Continue reading 

2) GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS - SECTION 1

This guide is intended to be used in conjunction with the FDA/Investigations Operations Manual (IOM25); the Code of Federal Regulations, Title 21 (21 CFR26); the Compliance Program for the Inspection of Source Plasma Establishments (CP 7342.002); and the Compliance Policy Guides (CPG) for Biologics, which are contained in Chapter 2 of the Compliance Policy Guides Manual. Continue reading

▣ ISPE 국내, 외 소식