게시판-관련소식
뉴스레터 2021년 5월호
2021-06-02 by ISPE Korea
MFDS 소식
생물학적제제 제조소 생물안전 평가지침(공무원지침서) 개정
생물학적제제 제조용 생물체 취급에 따른 위험으로부터 안전하게 제조가 이루어질 수 있도록 '생물학적제제 제조소 생물안전 평가지침(공무원지침서)'을 개정하였음을 알려드립니다.
'바이오의약품 사전 GMP 평가 지침(공무원 지침서)' 개정
'바이오의약품 사전 GMP 평가 지침(공무원지침서)'을 코로나19 상황 및 첨단재생바이오법 시행 등에 따라 개정하였음을 알려드립니다.
GMP 가이드라인
Draft Guidance for Industry: Cosmetic Good Manufacturing Practices
This document provides guidance to industry and other stakeholders (e.g., consumer interest groups, academia, other regulatory groups) on FDA’s current thinking concerning what constitutes Good Manufacturing Practices (GMPs) for cosmetics.
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs.
ISPE 국내외 소식
ISPE KOREA 온라인교육 (5월)
2021.05.25 (13:00~14:50)
Pharmaceutical Development Cycle from Idea to Business and GMP Compliances (바이러스기반 바이오의약품 개발 및 제품화 준비 과정)
강사: 박기랑 (주식회사 씨드모젠 / 대표이사)
2021.05.25 (15:00~15:50)
Lab Control
김부선 (한국에프디시법제학회 / GMP부문장)
Upcoming Conferences
2021 ISPE Global Pharmaceutical Regulatory summit
16 June 2021
Virtual Summit
Theme: Quality Risk Management Ensuring Shared Responsibility across Key Stakeholders
2021 ISPE Asia Pacific Pharmaceutical Mfg Conference
17-18 June 2021
Virtual Conterence
Theme: Sustainable Implementation of Quality Risk Management
Guidance Documents
Good Practice Guide: Maintenance 2nd Edition
Published: January 2021
Pages: 032
Member Price: $295.00
Non-Member Price: $595.00
APQ Guide: Corrective Action & Preventive Action (CAPA) System
Published: November 2020
Pages: 136
Member Price: $215.00
Non-Member Price: $515.00
ISPE Publishes ISPE GAMP RDI Good Practice Guide: Data Integrity by Design
Published: November 2020
Pages: 176
Member Price: $395.00
Non-Member Price: $695.00
Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
Published: August 2020
Papes: 236
Member Price: $495.00
Non-Member Price: $795.00
광고문의 TEL. 043-213-0442 E-MAIL. ispe@hanmail.net
ISPE Korea Affiliate | Office : 충북 청주시 흥덕구 직지대로 530, 702호 (송정동, 청주테크노S타워)