Management and Quality Control

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Chatammour Henderson
Marketing Management Seminar 640
February 25, 2012
Asterand Memorandum:

"What is the ultimate goal of Asterand’s quality control initiative?”

Asterand clearly did not have an effective quality control system in process prior to accepting its contract with Amgen to supply human tissue samples. Although Asterand is a new supplier to the biopharmaceutical and pharmaceutical industry, it will need to immediately establish quality control methods that will allow them to process orders correctly and deliver the final product to the standards and requirements of the procuring company. This will demonstrate Asterand’s ability to provide consistent and reliable human-tissue samples that meet the rigorous regulatory standards that the FDA places on all biotechnology and pharmaceutical products. As indicated in the case study, Asterand failed to meet Amgen’s quality standards on four occasions with different reasons. Asterand’s quality control challenges did not begin with Amgen. Asterand also faced challenges with implementing standardized protocols for storage and data collection across laboratories and hospitals, organizing and storing samples over long periods, and meeting the stringent regulatory requirements for clinical testing. It is imperative that Asterand addresses these challenges in order to stay in business and to expand the company. Human-tissue sampling is a new and innovative process that can be rejected by its target consumers if it does not have good quality control methods. Asterand’s ultimate goal of the quality control initiative is to be well received in the niche human-tissue sample market so that the company can increase sales growth, secure financing, attract investors and ultimately expand its operations.
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