AZ.BuildingAstraZeneca China is ISPE’s 2015 Facility of the Year Award Category Winner Project Innovation for their market supply solid dose facility located in Taizhou, China.

This project, consisting of over 533,000 sq. ft. of total site development represents Phase I of a planned three phase, greenfield site development in the new pharmaceutical center city of Taizhou.  Constructed in the record time of 20 months (ground-breaking to OQ lots complete) at a total project cost of $170M, this facility is capable of producing 5B tablets in a fully integrated solid dosage site including formulation, tableting, labeling, packing and distribution operations.  These operations further position AZ, already one of the largest in-country pharmaceutical manufacturers in China to further serve, with cost effective medicines, China’s growing regional markets. 

Accomplishments 

We went from ‘Farmers Fields to Pharma GMP Sample’ in less than two years. The team implemented existing project execution tools into parallel work streams which allowed them to go from  farmers’ fields to pharma GMP sample in a mere 22 months and to supply medicines to Chinese patients three months early. This would be considered a remarkable feat in the US or Europe. However, given the added complications of construction in China, this was truly a remarkable achievement. The facility was held to the same design and construction standards as every other facility built by AstraZeneca. In addition, the project was delivered 18% under budget with zero OSHA recordable accidents after 3.26 million safe man hours.

We implemented a business first in working with Taizhou authorities for contractor permitting.

Close cooperation with the local Taizhou authorities in the early planning phases and then throughout the project allowed us to contract individual construction packages, rather than a main contract as in the standard in China. This gave us greater control over quality and schedule and reduced the construction schedule by four months.

AZ.ProductionWe set a new standard in China for sourcing strategy. Of the 37 manufacturing equipment packages purchased, 32 were manufactured in China, leading to over US$10 million in savings. All packages purchased have been tested and validated and are 100% operational. This was facilitated by an extremely thorough assessment of local suppliers, including ensuring that we procured responsibly and avoided intellectual property infringement. We also invested efforts in improving suppliers’ fabrication and mentoring them through the AstraZeneca GMP validation documentation requirements.

 

 

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