Chime Biologics sell "Quality system"
Basic Information
538
33
10
4.4(58)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
Quality system
Service Provider(s)
Specifications
- Country of Origin: China
- Certification Standard: Quality system aligned with US 21 CFR Parts 210/211/600 (cGMP), 21 CFR Part 11, EU EudraLex GMP rules and applicable ICH guidelines
- Application: Enterprise quality system governing CMC activities for biologics manufacturing, advanced through regular internal reviews and external audits under a trained quality organization
- Regulatory Status: Licensed drug production under Hubei Provincial Medical Products Administration authorization, operated in alignment with US FDA and EU regulatory GMP frameworks
Documents
CE
FDA
GMP
ISO
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