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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:

  • Container closure systems like glass vials, stoppers, and related products.
  • Single-use systems and process contact materials.
  • All types of Medical Devices.

"We proudly showcase our global regulatory expertise, with a track record of obtaining product approvals across:

  • FDA, EMA, CHINA, KOREA, JAPAN, BRASIL, Türkiye(Turkey) and more.

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.


E&L Guidance LawPIC/S 2023 ANNEXES GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

관리자
2024-05-06
조회수 916

안녕하세요. 본 게시물은 

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS  

에 대한 3개의 문서를 첨부하였습니다.


PART I 

PART II

ANNEXES



제가 살펴본 부분은

Annex 1 의

EnL 관련 부분 과 PUPSIT 부분 입니다.



EnL 관련부분 중 일부 발췌

8.136 The extractable and leachable profiles of the SUS and any impact on the quality of  the  product  especially  where  the  system  is  made  from  polymer-based materials should be evaluated. An assessment should be carried out for each component  to  evaluate  the  applicability  of  the  extractable  profile  data.  For components considered to be at high risk from leachables, including those that may absorb processed materials or those with extended material contact times, an assessment of leachable profile studies, including safety concerns, should be taken  into  consideration. If  applying  simulated processing  conditions, these should accurately reflect the actual processing conditions and be based on a scientific rationale.



PUPSIT 관련 부분 중 일부 발췌

8.87  The integrity of the sterilised filter assembly should be verified by integrity testing 

before use (pre-use post sterilisation integrity test or PUPSIT), to check for damage and loss of integrity caused by the filter preparation prior to use. A sterilising grade filter that is used to sterilise a fluid should be subject to a non- destructive integrity test post-use prior to removal of the filter from its housing. The integrity test process should be validated and test results should correlate to the  microbial  retention  capability  of  the  filter  established  during  validation. Examples of tests that are used include bubble point, diffusive flow, water intrusion or pressure hold test. It is recognized that PUPSIT may not always be possible after sterilisation due to process constraints (e.g. the filtration of very small volumes of solution). In these cases, an alternative approach may be taken providing that a thorough risk assessment has been performed and compliance is achieved by the implementation of appropriate controls to mitigate any risk of a non-integral filtration system. Points to consider in such a risk assessment should include but are not limited to:

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