We provide
the Essential Value
We add value of your understanding of regulatory guidance on
Impurity
Extractables and Leachables
CCIT (Container closure Integrity testing)
Also, Saint-Gobain with Tubing and Bag as Single use system
We provide
the Essential Value
We add value of your understanding of regulatory guidance on
Impurity
Extractables and Leachables
CCIT (Container closure Integrity testing)
Also, Saint-Gobain with Tubing and Bag as Single use system
SWISS BASEL, E&L SCHOOL Welcome KOREA CUSTOMER
🌐 Quality by Design Inc. - Your Trusted Partner in E&L Studies 🌐
At Quality by Design Inc., we pride ourselves on being at the forefront of the Extractables and Leachables (E&L) study landscape. Our comprehensive services cover:
🔍 Consultation on the current E&L study approach
🔬 Critical assessment and evaluation
📜 Extractables & Leachables study and profiling
🧪 Identification & Toxicological evaluations
🛡️ Risk and Safety assessments
✅ Regulatory Registration support
Key Areas of Expertise:
"We proudly showcase our global regulatory expertise, with a track record of obtaining product approvals across:
Have an inquiry or need expert advice? 📩 Reach out to us at qbd@qbd.co.kr
For a more in-depth look at what we offer, visit our official website at www.qbd.co.kr
Let's navigate the complexities of E&L together! We look forward to partnering with you. 💼🌟
E&L and Pharmaceutical Regulatory Compliance AI
의약품 인허가 관련 질문하시고 간단한 답변 받으실 수 있습니다.
식품의약품안전처 고시 제2025–18호
식품의약품안전처 고시 제2025–18호 「약사법」제52조제1항에 따른 「대한민국약전」(식품의약품안전처 고시 제2023-75호, 2023. 12. 13.)을 다음과 같이 개정 고시합니다. 2025년 3월 27일 식품의약품안전처장 대한민국약전 일부개정고시 대한민국약전 일부를 다음과 같이 개정한다. 별표 3을 별첨 1과 같이한다. 별표 4를 별첨 2와 같이한다. 별표 5를 별첨 3과 같이한다. 별표 6을 별첨 4와 같이한다. 부칙 제1조(시행일) 이 고시는 고시 후 3개월이 경과한 날부터 시행한다. 제2조(적용례) 이 고시는 고시 시행 이후 최초로 제조업자가 제조하거나 수입 자가 수입한 의약품부터 적용한다.
Ministry of Food and Drug Safety Notification No. 2025-18
Pursuant to Article 52, Paragraph 1 of the Pharmaceutical Affairs Act, the Korean Pharmacopoeia (Ministry of Food and Drug Safety Notification No. 2023-75, Dec. 13, 2023) is hereby amended as follows:
March 27, 2025
Minister, Ministry of Food and Drug Safety
Partial Amendment Notification of the Korean Pharmacopoeia
The Korean Pharmacopoeia is partially amended as follows:
Appendix 3 shall be as shown in Attachment 1.
Appendix 4 shall be as shown in Attachment 2.
Appendix 5 shall be as shown in Attachment 3.
Appendix 6 shall be as shown in Attachment 4.
Supplementary Provisions
Article 1 (Effective Date) This notification shall come into effect three months after the date of promulgation.
Article 2 (Applicability) This notification applies to pharmaceuticals manufactured or imported for the first time after the enforcement of this notification.
내용 확인 및 고시 제2025-18호 다운로드하러가기-->
(별첨4) 연번2 :: 의약품 포장 및 전달 시스템에서의 추출물 평가
(별첨4) 연번3 :: 의약품 포장 및 전달 시스템에서의 침출물 평가