▣ GMP 소식

1) 정부조직 개편에 따른 행정규칙 일괄 개정

   (민원의 전자적 신청 및 처리에 관한 규정 등 168건)

「정부조직법」(법률 제11690호, 2013.2.23. 공포․시행) 개정 및 법령에서 위임된 사항과 그 시행에 필요한 사항을 정하는 등 종전 고시 및 타 부처로부터 이관되는 고시에 대하여 일괄 개정하여 업무의 혼란 초래를 방지하고자 함. Continue reading

2) Contract Manufacturing Arrangements for Drugs : Quality Agreements

This guidance applies to the commercial manufacturing2 of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), finished drug products, combination products, and biological drug products.3 4 For the purposes of this guidance, the term “manufacturing” includes processing, packing, holding, labeling operations, testing, and operations of the Quality Unit. Continue reading

 ▣ 가이드라인 소식

1) COMPRESSED MEDICAL GASES GUIDELINE 

   This guideline, issued under 21 CFR 10.90, states principles and practices of general applicability that are not legal requirements but are acceptable to the Food and Drug Administration (FDA). A person may rely upon it with assurance of its acceptability to FDA or may follow different procedures. Any person who chooses different procedures may, but is not required to, discuss the matter in advance with FDA to preclude expending money and effort on activity that FDA may later determine is unacceptable. Continue reading 

2) Biotechnology Inspection Guide (11/91)
       BIOTECHNOLOGY INSPECTION GUIDE REFERENCE MATERIALS AND

    TRAINING AID

This Guide was initiated by Robert C. Fish, Director, Division of Field Investigations (DFI). Mr. Fish asked Barbara-Helene mith, Ph.D., DIB, CHI-DO, to chair a workgroup to develop inspectional guidelines for Investigators in the area of biotechnology. Continue reading

▣ ISPE 국내, 외 소식

1) Singapore Conference

주    제 :"Enhancing Quality & Productivity for the Industry"

날    짜 : 30 June- 2 July

장    소 : Sands Expo & Convention Centre

회의내용 : Multiple workshops, Plenary Keynotes and breakouts

대    상 : Pharmaceutical Manufacturing Professionals from the Asia Pacific Region

            Continue reading 

2) ISPE Good Practice Guide: Cold Chain Management

Increasing volumes of cold products, the complexity of these products, and the complexity of the associated supply chain are causes for concern. Organizations need adequate control over cold chain of pharmaceutical and biopharmaceutical distribution systems. ISPE recognized the need for guidance in this area a dedicated team of subject matters experts from across the pharmaceutical and biopharmaceutical industries developed the ISPE Good Practice Guide: Cold Chain Management. Continue reading

▣ 연간 회원 및 스폰서 안내

2013년 연간 회비 변경 안내

ISPE 본부의 연간 회비가 변경되어 한국지부를 통한 회원가입시 적용 회비는 다음과 같습니다.