의약품 GMP평가 및 적합판정 관리체제 개선 등 의약품 GMP제조관련 규제혁신을 위해 「의약품 제조 및 품질관리에 관한 규정」(식약처 고시)을 개정고시 하였음을 알려드립니다.

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제네릭의약품 품질심사과정에서 빈번히 발생하는 보완사항을 사례중심으로 소개하여 효율적 심사자료 준비방안을 제공하고자 함

제네릭의약품 품질심사 주요 보완사례집(민원인 안내서) 제정('24.10.30)

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The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics). FDA’s authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970 (see Annex 1). PIC/S is a non-binding co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.

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January/February 2025 / Volume 45, Number 1

* 가입대상: 제약 및 Biopharma 관련업계 종사하는 모든 분

* 회원혜택

  - 한글판 Pharmaceutical Engineering 열람 및 다운로드 

  - 온라인 & 오프라인 교육비 40% 할인

  - 동영상 교육자료 무료시청

* 가입방법: 홈페이지(www.ispe.or.kr) - 회원가입 - 교육회원 - 신청서 작성 - 회원가입비 납부

* 회원가입비: 연 25만원 

2025 ISPE Facilities of the Future Conference

2025 ISPE Aseptic Conference

2025 ISPE Europe Annual Conference

Good Practice Guide: SMEPAC-Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition

Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition

Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)