MFDS 소식

2021년도 GMP 정책설명회 및 QbD 워크숍 발표자료

1. 2021년 GMP 주요정책 및 성과

2. 품목별 사전 GMP 평가, 운영

3. 총리령 및 고시 주요개정 사항 안내

4. 의약품 QbD 제도 추진현황

5. 스마트 공장구축 지원사업

6. QbD 기초기술개발 결과

7. QbD 예시모델 개발결과_K 경피흡수제

8. QbD 예시모델 개발결과_K 점안제

9. GMP 정책설명회 및 QbD 워크숍 관련 질의답변

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의약품 등의 안전에 관한 규칙 일부개정령 공포알림

'[시행 2022.1.21] [총리령 제1788호]

이 규칙은 약사법 및 같은법 시행령에서 총리령으로 정하도록 위임한 사항과 그 시행에 필요한 사항을 규정함을 목적으로 한다.

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GMP 가이드라인

Collecting and Providing 702(b) Portions of FDA Official Samples

This draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act) and ~

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CVM GFI #253 Good Manufacturing Practices for Animal Cells, Tissues, and Cell-and Tissue-Based Products

FDA’s Center for Veterinary Medicine (CVM) is issuing this guidance to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products meeting the definition of a new animal drug (ACTPs) with recommendations for meeting current good manufacturing practices (CGMPs) requirements.

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ISPE 국내외 소식

PHARMACEUTICAL ENGINEERING (한글판)

January-February 2022 / Volume 42, Number 1

Upcoming Conferences

2022 ISPE Aseptic Conference

2022 ISPE Europe Annual Conference

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Guidance Documents

GAMP Good Practice Guide: Enabling Innovation

Good Practice Guide: Good Engineering Practice 2nd Edition

Guide: ATMPs-Autologous Cell Therapy

Good Practice Guide: Controlled Temperature Chambers 2nd Edition 

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