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.
III. VISIBLE PARTICULATE MATTER
The use of a robust visual inspection program and the implementation of CGMP requirements are important to ensure products are not adulterated. For topical ophthalmic drug products packaged in opaque containers, appropriate technologies (e.g., X-ray spectroscopy) or destructive testing should be used to identify particulates within the accepted visible size range.[21]
Ophthalmic drug products with names recognized in the USP are generally required to also meet the particulate matter requirements in USP General Chapter <771> Ophthalmic Products—Quality Tests.[22] Noncompendial ophthalmic drug products should also follow the above USP General Chapter. Adherence to compendial standards can assist applicants and manufacturers in complying with CGMP regulations (e.g., 21 CFR 211.165(e), 211.167(b), and 211.194(a)(2)).
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[21] For topical ophthalmic drug products that include inherent visible particulates by design, such as suspensions and
emulsions, stability testing can be used to evaluate any changes in the particle size over the shelf life of the product.
See USP General Chapter <771> Ophthalmic Products—Quality Tests.
[22] See section 501(b) of the FD&C Act.