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.
Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular)
28 October 2021
Page 19 of 94
Leachable studies to detect, identify and quantify leachables and correlate with extractables. It is important to note however that while most leachables may have previously been identified as extractables, not all leachables may represent previously identified extractables (e.g., unanticipated leachables from manufacturing systems and interaction products)
Page 65 of 94
A properly conducted chemical characterization study should provide a robust and comprehensive profile of organic and inorganic extractables as a starting point, without compromising the surface integrity or shape of the component. Use of simulation studies with the final packaging and delivery system can facilitate identification and quantification of probable leachables to be toxicologically assessed. Chemical composition information and toxicological assessment of chemical profiles can indicate compounds of concern representing leachables for which to develop, optimize and validate targeted analyte methods. Non-targeted leachable screening methods may be useful for detection of unanticipated leachables but may not have the proper sensitivity or specificity for critical targets, which should be monitored by optimized and fully validated methods. The correlation of extractables to leachables with product quality is a process that involves understanding changes in the product attributes with respect to leachables, and safety throughout the biological product lifecycle.