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.
We have identified the following deficiencies regarding the extractables studies:
첨부화일 참조
Product Quality 1. We have identified the following deficiencies regarding the extractables studies: a. Different maximum daily doses (MDD) have been used to calculate the analytical evaluation thresholds (AETs) for the extractables studies. Specifically, in the (b) (4) 2011 report, an MDD of 8 mg/day was used to calculate the AET for volatile, semi-volatile and non-volatile, while in report TTP-IOX-M0083, 32 mg/day (i.e., 4 doses per day) was used for the calculation of AETs for polar compounds and elemental impurities. Clarify the discrepancies and provide the revised AETs with the correct MDD. b. You stated that the profile (b) (4) (b) (4) contained (b) (4) (b) (4) However, we cannot locate the information. Provide this information in your resubmission. 2. We have identified the following deficiencies regarding the leachable studies: a. We do not agree with your design for leachables testing following the concept of ICH Q1D “Bracketing and Matrixing designs for the stability testing of new drug substance and products.” Potential leachables may decompose to generate secondary leachables over time. Therefore, the full stability protocol must be followed in order to determine the full leachable trend throughout the product life cycle.
12. Leachable and extractable studies are critical to assure no elements or chemical substances are extracted from the manufacturing components under stress conditions to compromise quality of the drug product. We acknowledge you have presented extractable and leachable study results for rubber stopper and leachable screen of aged naloxone nasal spray DP in 3.2.P.2 to profile potential extractable contaminants. However, you did not offer any leachable or extractable studies result for all product-contact materials used in manufacturing process to demonstrate that no elemental or chemical impurities were extracted from your manufacturing (b) (4) (b) (4) under the given process operation conditions. Provide leachable and extractable data for all the formulation contacting (b) (4) components used during the manufacturing process and confirm all formulation contacting (b) (4) components used in manufacturing of the drug product meet the ASTM standards (b) (4) In addition, provide a statement of compliance to pertinent CFR sections for indirect food additives for all formulation contacting components used in manufacturing of the drug product.