GMP Validation Consulting for Global Peptide Manufacturing Facilities

Project Background：

The client operates GMP-compliant peptide manufacturing facilities in both China and the U.S., flexibly meeting demands from gram to ton scale. Both facilities regularly undergo and pass FDA on-site audits. With new factory expansions and full commissioning of high-end equipment, its capacity will rise significantly, further solidifying its leading position in the global peptide market.

AUSTAR Solution：

GMP-compliant validation consulting (meeting domestic & international standards) for clients' peptide drug projects across the lifecycle, including:

• Pre-C&Q consulting (e.g., validation master plans, validation summary reports);

• Updates to validation procedures & URS;

• Consulting & implementation of qualification/validation for HVAC systems, clean utilities, process equipment & computerized systems.

AUSTAR Value & Client Benefits：

• Meet NMPA GMP and FDA cGMP expectations/requirements, while referencing EU GMP, ISPE, ICH, PIC/S, WHO, etc.

• Enhance clients' overall validation management capabilities; achieve mutual growth and progress through collaboration and boost clients' international competitiveness.