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.
USP General Chapter Updates:
USP <1663> and <1664>
– Conducted a survey to identify stakeholder needs (Apr 2024)
– Intended to receive inputs and revise chapters
– Total 190 respondents
New Chapter Proposals:
– To address special considerations for Leachable assessment in various drug products
– USP Subcommittee is currently working on
• <1664.2> Leachable Chapter for Parenteral Drug Products [Tentative Timeline: FY 25 Q2]
• <1664.3> Leachable Chapter for Ophthalmic Drug Products [Tentative Timeline: FY 25 Q3]
• <1664.4> Leachable Chapter for Topical and Transdermal Drug Products [Tentative Timeline: FY 25 Q4]
• <1664.5> Leachable Chapter for Oral Dosage forms [Tentative Timeline: FY 25 Q3]
Existing chapters to support E&Ls:
– <1663> Assessment of extractables associated with pharmaceutical packaging / delivery systems.
– <1664> Assessment of drug product leachables associated with pharmaceutical packaging / delivery systems.
– <1665> Characterization and qualification of plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances and products
– <1664.1> Orally inhaled and nasal drug products (OINDPs).
– <381> Elastomeric components in injectable pharmaceutical product packaging / delivery systems
– Others (<87>, <88>, <665>, <661.1>, <661.2>, etc.,)