Bi Ruifeng ， Qualified Person, Sanofi Hangzhou Pharmaceutical Company

Topic: Pharma Solids Products Transfer Risk Assessment

Speaker Bio

She has over 25 years of work experience in the pharmaceutical industry, more than 15 years experienced in quality management , experienced in products technology production and registration area of pharmaceutical company.

Quality senior Manager, Sanofi Hangzhou Pharma site

l Leading Quality Unit for operations of QA, QC, RSO and validation management.

l Led EU-GMP project at site and passed ANSM&MHRA joint inspection successfully and got EU GMP certificate: Gap analysis, CAPA identified, CAPA effectiveness review, mock inspection, RIP inspection, ANSM&MHRA joint on-site inspection and CAPA made to EU.

l Leading the quality tasks of product transfers from oversea sites to China. Experienced in risk assessment for products transfer.

Presentation Summary

TECHNOLOGY TRANSFER

Regulations Background for technology transfer and phases:

l Phase 0: Preliminary feasibility study for technology transfer

l Phase 1: Technology transfer application and organization

l Phase 2: Technology transfer plan

l Phase 3: Technology transfer process preparation

l Phase 4: Technology transfer implementation and verification

l Phase 5: Technology transfer closed and follow-up

Technology transfer document list

Pre-condition for Risk assessment—Gap analysis

Key milestone and tool for Risk assessment

Risk assessment Example of Pharma solids products

Critical control for Risk assessment of Pharma solids product