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.
Outsourcing For Success: Part Two
Webinar: Sustainable Approaches in Analytical Method Development for Determination of Leachables
Analytical methods used for analytical determination of pharmaceutical impurities in drug products (such as additives or stabilizers which have leached from drug device container closures) are typically either quantitative methods or limit tests. As per the requirements of ICH Q2(R1), one would typically validate accuracy, precision, specificity, LOQ, linearity and range for quantitative methods and for a limit test we would validate LOD and specificity.
However, including robustness as a parameter in the method development as well as performing a pre-validation by checking other parameters like precision, linearity and so on enables you to take a more sustainable approach to the validation of the method. A robustness study can provide information on critical parameters which affect the method if not properly controlled and allowed informed setting of system suitability parameters later on. With a robust method, there is a typically reduced need for further development work and demands on staff/instrument time leading to a faster more efficient method validation.
In this webinar, our expert Dr J Susanne Becker, describes, with case studies, how sustainable approaches in analytical method development for drug products and drug product devices can be achieved.
WATCH NOW>
Meet our Expert
Dr. J. Susanne Becker, Director of Extractables & Leachables Laboratories, Intertek
Susanne completed her Ph.D. at the University of Konstanz in analytical chemistry. After seven years experience in the pharma industry at Aeropharm and Baxter, she joined Intertek (Schweiz) AG in April 2016 as the Project Leader in E&L and, since 2021, is now the Head of Extractables and Leachables Labs.
PART One :: Webinar: Stability Study Considerations Throughout the Drug Product Life Cycle
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