1. GMP 소식

1) 대한민국약전외 의약품 기준 제4개정 간행물 배포

지난해 12월 전면 개정된 '대한민국약전외 의약품 기준' 제4개정(식품의약품안전청 고시 제2012-142호, 2012.12.31) 의 주요 개정내용 및 새로운 기준규격을 사용자가 쉽게 찾아볼 수 있도록 간행물로 발간하여 배포하오니 업무에 참고하시기 바랍니다. Continue reading

2) Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review.

This Manual of Policies and Procedures (MAPP) and its attachment assist the review staff within the Center for Drug Evaluation and Research (CDER) on good review management principles and practices for submissions during the investigational new drug application (IND) phase of drug development, promote excellence in review science, and provide a consistent approach to the conduct and content of the IND review process. Continue reading

2. 가이드라인 소식

1) Comparability Protocols Protein Drug Products and Biological Products – Chemistry, Manufacturing, and Controls Information

This guidance provides recommendations to you, the applicant, on preparing and using comparability protocols for changes in chemistry, manufacturing, and controls (CMC) of products2 in approved marketing applications. A comparability protocol is a comprehensive plan that describes the specific tests and validation studies and acceptable limits to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, or potency of the product, as they may relate to the safety or effectiveness of the product. Continue reading

2) Pharmaceutical Quality Control Labs (7/93)

This inspection guide supplements other inspectional information contained in other agency inspectional guidance documents. For example, Compliance Program 7346.832 requiring pre-approval NDA/ANDA inspections contains general instructions to conduct product specific NDA/ANDA inspection audits to measure compliance with the applications and CGMP requirements. This includes pharmaceutical laboratories used for in-process and finished product testing. Continue reading

3. ISPE 국내, 외 소식

1) 2013 Indianapolis Training

13-15 May 2013, Indianapolis, Indiana USA

Topics include:

-     Sterile Drug Manufacturing (T12)

-     Risk Based Approach to GXP Process Control Systems: Applying the GAMP Good Practice Guide (T21)

-     GMP Auditing for the Pharmaceutical Industry (G07)

-     Oral Solid Dosage Forms (T10)

-     HVAC for Pharmaceutical Facilities (T14)

-     http://www.ispe.org/2013-may-indianapolis-training

2) ISPE Good Practice Guide : Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)

The ISPE Good Practice Guide : Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) aims to provide practical operational guidance and drive a consistent industry approach to the use of NIMPs. The Guide contains criteria for classifying NIMPs and an overview of current NIMP regulatory requirements. Continue reading

4. 연간 회원 및 스폰서 안내

2013년 연간 회비 변경 안내

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