게시판-관련소식
뉴스레터 2017년 12월호
2017-12-19 by ISPE Korea
GMP 가이드라인 PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions. |
Topical Drug Products
The purpose of this guide is to provide field investigators, who are familiar with the provisions of the Current Good Manufacturing Practice (CGMP) regulations for pharmaceuticals, with guidance on inspecting selected facexts of topical drug product production. The subjects covered in the guide are generally applicable to all forms of topical drug products, including those that are intended to be sterile.
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ISPE 국내외 소식
PHARMACEUTICAL ENGINEERING [한글판]
November-December 2017/ Volume 37, Numer 6
12. COVER
Crossing Over to Large Molecules
Bridges to Biomanufacturing
35. SPECIAL REPORT
Compliance Transparency Control
50. TECHNICAL
TECHNICAL-FACILITIES AND EQUIPMENT
The Capacity Challenge-Shifting Paradigms in Biopharmaceutical Facility Development: Point of View
John Noble, PhD
TECHNICAL-FACILITIES AND EQUIPMENT
Integrated VPHP Decontamination Systems: The Emerging Utility
John Klostermyer, Bruno Aze, Alberto Garcia, and Don Eddington
TECHNICAL-PRODUCTION SYSTEMS
A Statistical Approach for CU Testing of CPV Batches and Comparison with USP <905> UDU
Roger Zanon, Limin Shi, kyle Johnson, and Jeff Hanson
* International Membership 여러분에게 12월 발송 예정입니다.
Upcoming Conferences
2017 Biopharmaceutical Leadership Forum
03 December 2017
San Francisco, CA USA
2017 Biopharmaceutical Manufacturing Conference
04 December 2017 - 06 December 2017
San Francisco, CA USA
2018 ISPE Facilities of the Future Conference
20 February 2018 - 22 February 2018
Bethesda, MA USA
2018 ISPE Aseptic Conference
06 March 2018 - 07 March 2018
Reston, VA USA
2018 ISPE Europe Annual Conference
19 March 2018 - 21 March 2018
Rome, Italy
Guidance Documents
GAMP Good Practice Guide: IT Infrastructure Control and Compliance
- Published: August 2017
- Pages: 168
ISPE Good Practics Guide: Decommissioning of Pharmaceutical
- Published: June 2017
- Pages: 132
GAMP® Guide: Records and Data Integrity
- Published: March 2017
- Pages: 152
VIEW ALL GUIDANCE DOCUMENTS >>
회원가입안내
회원구분 | 회비 | 내용 |
기업체 소속회원 (재가입) | 438,000 (379,000) | - 제약, 공학, 기술의 기업체 소속의 개인 - 회원추천 12명시 1년회비 면제 |
정부(규제)기관 소속회원 | 무료 | - 정부기관 또는 규제기관에서 근무하는 공무원 - 제출서류 : 공무원증 |
교육기관 소속회원 | 187,000 | - 교육기관에 근무하는 개인 |
학생 회원 | 30,000 | - 제약산업에 관심있는 전문, 종합대학 학생 |
영프로페셔널 회원 | 187,000 | - 졸업 후 제약산업에 종사하는 10년 미만인 자 - 다른 분야에서 제약산업으로 업무변경한지 10년미만인 자 - 졸업 또는 업무변경 후 4년까지 회원유지 가능 - 제출서류 : 성적증명서, 졸업증명서, 재직증명서 (택1) |
* 회원가입신청서와 회비를 보내주세요. (ispe@hanmail.net/신한100-029-372879)
스폰서안내
(단위 : 천원)
구분 | 다이아몬드 | 플래티넘 | 골드 | 실버 | 브론즈 |
회원권 | 4명 | 2명 | 2명 | 1명 | 1명 |
스폰서비 | 14,000 | 8,000 | 5,000 | 3,500 | 2,500 |
매거진광고 (광고위치) | 전면컬러 (겉표지) | 전면컬러 (안표지) | 전면컬러 (내지) | 1/2컬러 (내지) | 1/2흑백 (내지) |