Reliable Partner Who Can Meet the Compliance Requirements of Global Enterprises

Pfizer

Pfizer's history starts in 1849 for more than 170 years. Pfizer has been committed to applying science and global resources to improve health and well-being at every stage of life. Pfizer strives to set the standard for quality, safety and value through the exploration, development and manufacture of drugs. Pfizer's diverse products of global healthcare include biotherapeutics, small-molecule drugs and vaccines, as well as a rich portfolio of world-renowned health medicines.

Project Background

As one of the world's top ten pharmaceutical companies, Pfizer owns several manufacturing bases in China. Since 2014, AUSTAR has been providing high-quality compliance verification services for Pfizer Pharmaceutical (Wuxi) Co.,Ltd., a manufacturer of sterile and lyophilized anti-tumor agents.

Solution

AUSTAR, with its deep insight and rich experience in pharmaceutical technology and comprehensive project execution capabilities, provided Pfizer Pharmaceutical (Wuxi) Co.,Ltd. with high airtight measuring and dispensing isolators, C&O verification and consulting services, overall verification services of freeze-dried filling linkage line and self-cleaning test and consulting services for clean areas.

Benefits

Through the compliance consulting services provided by AUSTAR, the project fully conforms to the standards of China GMP, US FDA CGMP, EU GMP and Japan PMDA. Among others, the containment isolation system has passed the SMEPAC test by HPC America with excellent data, which perfectly fits OEB5's requirements.