MFDS News

「실험동물에 관한 법률 시행규칙」 일부개정령(안) 입법예고(공고 제2019-380호)

「실험동물에 관한 법률 시행규칙」을 개정함에 있어 그 취지와 주요내용을 국민에게 미리 알려 의견을 수렴하고자 「행정절차법」 제41조에 따라 다음과 같이 공고합니다.

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2019년 제2차 QbD 워크숍 자료

2019년 7월 18일에 개최된 "2019년도 제2차 QbD 워크숍"의 교재를 공개합니다.
1. CTD 품질평가자료 작성
2. K정제 개발 사례
3. K캡슐 개발 사례
4. 생물학적동등성 복합의약품 QbD 적용 사례
5. PAT 기술을 통한 의약품 품질관리

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GMP Guideline

Quality Considerations for Continuous Manufacturing

This guidance provides information regarding FDA’s current thinking on the quality 15 considerations for continuous manufacturing of small molecule, solid oral drug products that are 16 regulated by the Center for Drug Evaluation and Research (CDER).

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Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for ~

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ISPE News

2019년 상반기 정기과정 완료

- 교육명: QbD in developing drug products & Data integrity
- 교육일자: 2019.08.22(목) 9:00~18:00
- 교육강사: 김종민(한가람경영혁신연구소), Charlie Wakeham(ISPE Headquarter)
- 교육장소: 판교 쏠리드스페이스 B1, 로툰다홀
- 교육참석인원: 47명 (식약처외 20개사)

Pharmaceutical Engineering 한글판

July-August 2019, Volume 39, Number 4

10. COVER STORY: IMPROVING PHARMACEUTICAL CONNECTIONS WITH PATIENTS
14. APPLICATION OF THE SOC2+PROCESS to Assessment of GxP Suppliers of IT Services
23. 2019 ISPE ASEPTIC CONFERENCE: Interactive Regulatory Panel Addresses Multiple Aseptic Issues
28. ACCELERATED PHARMACEUTICAL Product Development, Registration, Commercialization, and Life
38. ISPE EUROPE ANNUAL CONFERENCE: Digitization, Technologies, and More
48. ISPE BRIEFS: ISPE Launches Complimentary Webinar Series
49. A STRATEGY FOR THE ANALYSIS OF DISSOLUTION PROFILES
60. ANEW QUALIFICATION APPROACH for Mobile Purified Water Systems
* International Membership : 9월초순 배송예정

Upcoming Conferences

2019 ISPE Europe Biotechnology Conference

25-26 September 2019

Brussels, Belgium

2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference

30 September- 1 October 2019

Singapore, Asia

2019 ISPE Annual Meeting & Expo

27-30 Oct 2019

Las Vegas, Nevada

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Guidance Documents

GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

Published: May 2019

Pages: 156

Practical Implementation of the Lifecycle Approach to Process Validation

Published: March 2019

Pages: 208
Bound version: Available 27 March 2019

Good Practice Guide: Technology Transfer 3rd Edition

Published: December 2018

Pages: 152
Bound version of the guide will be available after 18 Jan 2019

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회원가입안내

※ ISPE 한국지부 대행요청시: 회원가입신청서와 회비를 보내주세요.
  (ispe@hanmail.net / 신한 100-029-372879 아이에스피이코리아)
※ 직접 가입시: www.ispe.org - Membership & Communities - Membership - Join Now
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스폰서안내

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