바이오의약품 전문수탁 제조업체 GMP 적합판정 제도를 보다 합리적으로 운영하기 위해 '바이오의약품 전문수탁 제조업체 GMP평가절차(공무원지침서)'를 개정하였음을 알려드리니 업무에 참고하시기 바랍니다.

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의약품 표준제조기준 중 새로운 제형, 신규 배합성분의 추가 등을 통해 일반의약품을 활성화하여 소비자의 일반의약품 선택 폭을 확대하고자 「의약품 표준제조기준」 (식약처 고시) 일부 개정고시안을 붙임2과 같이 마련하여 행정예고하였음을 알려드립니다.

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This guidance describes FDA's policies regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 501(a)(2)(B) of the FD&C Act, a drug is deemed to be adulterated if it is not produced in accordance with CGMP.

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This PIC/S Recommendation sets out a simple and flexible Quality Risk Management tool that may be used by Inspectorates when planning the frequency and scope of GMP. It is a methodology that is based upon the concept of rating manufacturing sites on the basis of an estimated risk that they may pose to patients, consumers, animals and users of medicines. The methodology also takes into account the risk to product quality.

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November-December 2024 / Volume 44, Number 6

* 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 

2024 ISPE Pharma 4.0 and Annex 1 Conference

2025 ISPE Facilities of the Future Conference

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

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

Good Practice Guide: Unique ID of Glass Primary Containers