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Sterile filtration through validated 0.22-micron membrane filters prior to aseptic filling Continuous environmental monitoring airborne particulate counts, surface sampling, personnel monitoring Step 3: Fill-finish and primary packaging Sterile filling into pre-filled syringes (PFS), vials, or auto-injector pen cartridges 100% automated visual inspection for particulates, fill volume accuracy, and container integrity Aluminium crimp-sealed or pen-cartridge packaging validated for 28C cold-chain stability Step 4: Quality release and export documentation Batch Manufacturing Records (BMR), media-fill studies, and CAPA documentation available for importer audit Certificate of Analysis, Certificate of Origin, MSDS, and stability summary provided per export shipment WHO-GMP compliance status confirmed by CDSCO-endorsed inspection certificate valid in 2026 for 100+ markets
10.1016/j.jhep.2019.06.017 71 SunH.ShuJ.TangJ.LiY.QiuJ.DingZ.et al (2024)
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