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원료의약품 핵심 품질 특성(Critical Quality Attribute; CQA) 및 품질관리(IPC, QC) 항목 출처 의약품 품질 위해 평가 가이드라인, 식품의약품안전처, 2016.12 핵심 품질 특성(Critical Quality Attribute; CQA)은 목표 제품 품질을 보장하기 위해 적절한 한도, 범위 또는 분포 이내여야 하는 물리적, 화학적, 생물학적, 미생물학적 특징이나 특성 ▶ 일정 범위의 수치(정량적) 또는 범위(정성적)에 포함되어야 하며, 이 수치는 위험의 심각성을 바탕으로 설정하고 제품 특성이기 때문에 위해관리 결과에 따라 기준이 변경되지 않음. ▶ CQA를 바창으로 Risk Assessment 실시해야 함. ▶ 제품에 대한 지식과 공정에 대한 이해가 높아질 수록 CQA 목록을 변형할 수 있다. 다음은 가이드라인에 제시된 일반적인 원료의약품의 핵심 품질 특성 [표 2] 원료의약품에서의 핵심 품.. 2020. 10. 14.
의약품 품질 위해 평가(ICH Q9 Risk Assessment) 정리(1) 일반사항 참조 (본 내용 하단에 파일 첨부함) 1. 의약품 품질 위해 평가 가이드라인, 식품의약품 안전처, 2016.12 2. ICH Q8(R2) 의약품 개발, _(가이드라인 한글 번역본, 식약처, 2014.1 3. ICH Q9 품질 위해 관리,2005.11.9. _가이드라인 한글번역본, 식약처, 2014.11 4. ICH Q10 의약품 품질시스템, 2008.06.04_가이드라인 한글번역본, 식약처, 2014.11 1) 위해 관리 도구는 여러가지. ICH Q9에서는 Fault tree analysis(FTA), Hazard operability analysis(HAZOP), Hazard analysis and critical control points(HACCP), Preliminary hazard analysi.. 2020. 10. 13.
200805 개념설계(Conceptual Design) 및 공기조화시스템(HVAC System) 보호되어 있는 글 입니다. 2020. 8. 5.
How to Plan Smoke Studies / 기류패턴 확인시험 실시방법 https://www.pharmtech.com/view/how-plan-smoke-studies How to Plan Smoke Studies Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility. www.pharmtech.com irflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility. Mc_Mon/shutterstock.com This article was published in.. 2020. 8. 4.
PCR, RT-PCR, qPCR, RT-qPCR 차이/다른점 https://www.enzolifesciences.com/science-center/technotes/2017/march/what-are-the-differences-between-pcr-rt-pcr-qpcr-and-rt-qpcr?/ TechNote: What are the differences between PCR, RT-PCR, qPCR, and RT-qPCR? Basic PCR methods have further advanced from simple DNA and RNA detection. Below, we have provided an overview of the different methods of PCR and the reagents we provide at Enzo Life Science.. 2020. 6. 2.
Development and Manufacture of Commercial ELISA Kits(ELISA Kit의 공통적인 개발 및 제조) Development and Manufacture of Commercial ELISA Kits The rigorous research and development process and strict manufacturing conditions of commercially produced ELISA kits offer a number of advantages for clinicians and medical research. In Europe, most diagnostic companies operate according to the internationally recognised quality assurance system, ISO13485 and the tests CE marked according to .. 2020. 5. 26.
ELISA Development Guide / ELISA 개발 가이드 https://www.creative-diagnostics.com/ELISA-Development-guide.htm ELISA Development Guide - Creative Diagnostics Developing an ELISA An ELISA system consists of 4 technical elements: 1) ELISA plate-coating strategy 2) Antigen resources and Antibody pairs 3) Conjugating/labeling strategy 4) Enzyme and chromogen 1. ELISA Coating Strategy When developing a new ELISA for www.creative-diagnostics.com .. 2020. 5. 26.
연질캡슐 제조 공정(2) (Manufacture of Soft Gelatin Capsules) https://www.pharmapproach.com/manufacture-of-soft-gelatin-capsules/# Manufacture of Soft Gelatin Capsules - Pharmapproach.com Manufacture of soft gelatin capsules: This article provides an overview of the basic components of soft gelatin capsule shell as well as the various meth... www.pharmapproach.com Manufacture of Soft Gelatin Capsules Softgels are manufactured using the following methods 1... 2020. 5. 14.
연질캡슐 제조 공정(How to Make Softgel Capsules: The Complete Guide) 출처: https://www.saintytec.com/how-to-make-softgel-capsules/ How to Make Softgel Capsules: The Complete Guide - SaintyTec Today’s guide will focus on how to make Softgel capsules. It will take you through the Softgel capsules formulation, ingredients, equipment, and other processing procedures, among other critical aspects. By the end of it all, you will not only know how to www.saintytec.com 의역/.. 2020. 5. 12.
[PDA News] How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 of 6) https://pda.inloop.com/en/article/137316?utm_source=ElasticEmail-sb-pda&utm_medium=newsletter&utm_campaign=pda-1984-s-en-080520&itd_did=1984&itd_uid=42067 How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 of 6) Over the previous five Blogs in this series we have discussed the critical quality attributes to consider in a robust Quality .. 2020. 5. 11.
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