의약품 GMP적합판정서 기재방법을 EU등 국제기준과 조화하여 명확히 하기 위한 「의약품 GMP 적합판정 및 적합판정서 발급 관련 업무처리방안」(공무원지침서)를 붙임과 같이 개정하였음을 알려드립니다.

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의료제품의 시행착오를 줄이고 신속한 제품화 지원을 위해 제품화지원팀에서 수행한 의약품, 바이오의약품, 의료기기 분야의 주요 상담 사례를 정리하여 발간하여 공유하오니 업무에 많은 활용이 되길 바랍니다.

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The guidance is intended to alert pharmaceutical manufacturers and pharmacists in Statelicensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. During the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE), the Food and Drug Administration (FDA) became aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizer products that were manufactured with methanol or methanol-contaminated ethanol.

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The manufacture of sterile products covers a wide range of sterile product types (active substance, excipient, primary packaging material and finished dosage form), packed sizes (single unit to multiple units), processes (from highly automated systems to manual processes) and technologies (e.g. biotechnology, classical small molecule manufacturing systems and closed systems), This Annex provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and endocoxin/pyrogen contamination is prevented in the final product.

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September-October 2023 / Volume 43, Number 5

* 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 

2023 ISPE Pharma 4.0 & Annex 1 Conference

2024 ISPE Facilities of the Future Conference

2024 ISPE Aseptic Conference

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Good Practice Guide: Process Gases 2nd Edition

Guide: 503B Compounding

Good Practice Guide: Containment for Potent Compounds

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