Successful debut in growth market
Lueneburg, Germany / Shanghai, P.R. China, April 15, 2010 April 15, 2010 - China is among the strongest growing pharmaceutical markets worldwide, yet Manufacturing Execution Systems (MES) are still unknown territory for many local manufacturers. Against this background, the response to Werum's first MES Day in China was very positive. On March 31st, 55 guests attended the event in Pudong, Shanghai, hosted by Werum, the international leading supplier of MES for pharmaceutical and biopharmaceutical industries, and its local partner Bayer Technology and Engineering Shanghai (BTES). Among the guests were General Managers, as well as Production, Quality and Technical Managers from 30 different local pharmaceutical companies.
Regulatory trends in China
BTES experts and international guest speakers presented discussions on the event's theme: "How to improve efficiency, quality, safety and regulatory compliance in pharmaceutical production".
The morning session was dedicated to comprehensive topics such as regulatory trends in China and validation of computerized systems. Henry Tjong from BTES examined how the new national Good Manufacturing Practice (GMP) regulations will improve public safety and push national regulations closer to international standards. This trend is expected to increase due to growing demand from the local market for high quality and safe pharmaceutical products, pressure from the World Health Organization (WHO) and exports of products to external markets. Local Chinese pharmaceutical producers are therefore beginning to follow the current trend of investing in supporting technologies such as Manufacturing Execution Systems (MES) in order to maintain a sustainable business.
Insights into GAMP 5
Tony Margetts from Factorytalk Bangkok, co-author of the new Good Automated Manufacturing Practice GAMP 5 guideline, explained the key concept of GAMP 5 for the validation of computerized systems. Validation is a structured and documented approach to testing computerized systems. It is not only mandatory in order to comply with GMP regulations, validation is also needed to assure that the system is designed and verified to be fit for its intended use. The audience especially appreciated the workshop which revealed the risks to be considered during weighing and dispensing operations, and illustrated how an MES helps to reduce these risks. The general tendency in the pharmaceutical industry is to choose mature standard products in order to reduce the work involved in validation and to benefit from exchange of experience within the pharmaceutical community.
In the afternoon session, Robin Wu from BTES demonstrated the Chinese version of
PAS-X, the MES by Werum. As a modular standard product, PAS-X enables an incremental deployment strategy to introduce different functionalities, taking into consideration the latest business and production needs. Typically, the weighing and dispensing function is the starting point for most MES projects.
Case studies from AstraZeneca and Novartis
The benefits of using PAS-X were illustrated by two customer case studies:
Fuming Wu from AstraZeneca outlined how PAS-X has recently been introduced for weighing and dispensing operations at AstraZeneca's facility in Wuxi, with support from BTES. This project is the first ever MES installation on Chinese soil. The benefits have been identified as standardization of processes, increased efficiency resulting from exchange of experience and common resources, the flexibility to deal with new business, smooth data exchange with the Enterprise Resource and Planning system and guidance for operators in the weighing booth.
Marcus Carpentier from Novartis Singapore discussed how to keep pace with technology, and how to leverage it for the ultimate benefit of the patient by increasing efficiency, the stability of the process, compliance with GMP regulations and transparency. Furthermore, Novartis takes a global approach and measures the considerable improvements against Key Performance Indicators.
The large number of participants at the MES Day clearly reflects recent trends: local Chinese pharmaceutical producers are planning to implement MES, and some are already in the supplier selection phase.
Participants and hosts both came to a positive conclusion: "We see huge potential for PAS-X in China," says Christian Wölbeling, Senior Director Marketing & Sales at Werum. "Together with BTES we can expect further expansion of our commitment within this local market."
About Bayer Technology and Engineering (Shanghai)
Bayer Technology and Engineering (Shanghai) Company Limited offers fully integrated solutions along the life cycle of chemical/pharmaceutical plants - from development, through engineering and construction, to process optimization for existing plants, market evaluation and investment consultation and services in China and Asia. As a constantly innovative company, BTES also develops new technologies in Microreaction Technology, Healthcare Process Engineering, Bio-mass Conversion, and technological solutions for Environmental Protection. The company has been established to serve the growing number of customers in the Asia-Pacific region. The competence of BTES in Asia lies in their excellent knowledge of the local market, coupled with global expertise and a professional team. As a competent and competitive provider of superior technological services with economic solutions for the Bayer Group and external companies, BTES supports their customers with courage, creativity, and vision.
Additional information about BTES: www.bayertechnology.cn.
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