반응형 제약 및 의료기기, GMP/PDA News 및 뉴스레터7 CAPA 실시 여부 판단 기준에 대하여 What Should Really Trigger a CAPA? | Quality Digest What Should Really Trigger a CAPA? Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters from the FDA year after year, and many companies struggle to identify when they sh www.qualitydigest.com Corrective and preventive action.. 2022. 3. 2. 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. [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. [PDA News] Quality Risk Management in Annex 1; 6.1_20/04/23 https://pda.inloop.com/en/article/136917/quality-risk-management-in-annex-1-6 Quality Risk Management in Annex 1; 6.1 The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in al pda.inloop.com The use .. 2020. 5. 8. [PDA News] Quality Risk Management Principles in Annex 1, Section 2_20/04/23 https://pda.inloop.com/en/article/136832/quality-risk-management-principles-in-annex-1 Quality Risk Management Principles in Annex 1, Section 2 The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in .. 2020. 5. 8. [PDA News] Cleanroom Process Risk Assessment Per Annex 1_20/03/01 https://pda.inloop.com/en/article/137266/cleanroom-process-risk-assessment-per-annex Cleanroom Process Risk Assessment Per Annex 1 In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one. Process Risk Assessment: Why it’s importan pda.inloop.. 2020. 5. 8. [PDA News] Isolator Launch in South Korea(에이프로젠의 아이솔레이터(optima) 도입과 관련하여)_20/04/30 Isolator Launch in South Korea To date, very few filling and capping machines with isolator technology have been installed in South Korea, let alone in Asia. All of this will soon change. Both Oh-sung Na (Aprogen Biologics) and Peter Kim (Optima Korea) are certain of it because Aprogen pda.inloop.com [원문 위 링크 참조] * 의역/오역 있음. Isolator Launch in South Korea Optima Pharma GmbH / April 30 To date, v.. 2020. 5. 7. 이전 1 다음 반응형
