Quality Control System
Royabio constructs a biological quality control system, from material to product, strictly following the Good Manufacture Practice of Medical Products (2010 Edition). Via the management routes of production and quality control, we conduct systematic supervision covering staff, equipment, materials, regulations and environment. In total 162 key nodes and 1057 details are in control to guarantee the safety, stability and applicability of each batch of products.
Quality Assurance (QA)
•Reference standard:
《ISO 9001: Quality Management System (2015)》
《Good Manufacture Practice of Medical Products (2010 Edition)》
Quality Control (QC)
•Reference standard:
《Pharmacopoeia of the People’s Republic of China (2015 Edition)》
《USP42-NF37》
| Material Control |
>Acceptance tests of outer packaging material, label, PET bottle, blood bag, experiment reagents and so on. |
| Environment Control |
>Operational/at-rest tests of the indices of airborne particle, settling bacteria, planktonic bacteria, surface microorganism and so on. |
| Process Control |
>Detections of the integrity of filtering system, and tests monitoring water after cleaning and intermediate samples. |
| Biochemistry and Physical Chemistry |
>Biological and physiochemical tests of endotoxin, IgG, osmotic pressure, pH, antibiotic and so on. |
| Microorganism |
>Detections of virus, bacteria, mycoplasma, phage and so on. |
| Cell Culture |
>The comprehensive evaluation system consisted of multiple indicators on more than 60 cell lines. |
