From January 10 to January 14, delegation of POLY¡¯s cooperation partner Ratiopharm, which is the biggest generic pharmaceutical company in Europe, came to POLY¡¯s plant to make a site audit.
The scope of this audit includes the EU GMP Part 1, ICH Guidelines, DIN EN ISO 14644 (Sterile), and current EU GMP Annexes. There is Warehouse/Logistic, Quality Control, Quality Assurance, Production, Technical Services, Stability Control, and Microbiological Laboratory in the organizational Units Audited.
After 2 days audit by the 5 persons in the audit team, they got a satisfied conclusion that POLY Pharm is an excellent manufacturer of the discussed cooperation project. From the quality (GMP) point of view the project lyophilized powder in vials at POLY can be continued. Ratiopharm and POLY Pharm will maintain a close contact in the future.
