Sartorius Stedim Biotech (JA-1118)

Audit # JA-1118
Region China
Standards Single-Use Systems
Company Sartorius Stedim Biotech
Location Beijing
Date May 25-28, 2020 (see also follow on audit in Aug 2020)
Materials Single use components, Flexel Liner  Non-Sterile Tankliner product Manufacturing  Validation process for sterilizer and QP for a product range  Sterile Tankliner product (exclude final release process) > however we can show all SOP and project but not a batch execution.  Validation package(exclude sterilization validation) of STR product  Beijing Quality System

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