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.
Guide to creating a BioPhorum Extractables Test Reports
Title page
The title page should include:
Study summary
The Study summary for SUS components tested should consist of:
Study design
Outline of the study design information must follow the BioPhorum Extractables Data Summary (BEDS) spreadsheet template. It includes information on:
Summary tables
One summary table for organic compounds and one summary table for elements should be included in the report. The formats of the summary tables must follow the BEDS
spreadsheet template. In addition to including the summary tables in the Extractables Test Report, the summary tables need to be made available in BEDS spreadsheet format. It is optional to report structures of identified compounds.
Results from analyses
Results from each individual analysis technique should be reported separately. It is highly recommended, but not mandatory, to follow the format provided in the BEDS spreadsheet template.
Analytical methods
Information on each individual analysis technique should be reported separately. It is highly recommended, but not mandatory, to follow the format provided in the BEDS spreadsheet template. Information on analytical methods shall include:
Deviations
Any deviations observed during the study needs to be documented.
Terminology
Acronyms used in the Extractables Test Report need to be explained.
Revision history
Revision history of the report needs to be included, describing changes made to the Extractables Test Report after initial release.
The final reporting should be within the oversight of the company’s quality management system and can be in one of the following formats (or a combination):