What Is
Biologics and Contract Manufacturing Company
ensures batch control system data accuracy
Precision Pharma Services, Inc. is a new business wich
operates a biological products facility originally
started in 1979 as part of the Greater NYC Blood
Program. The FDA approved facility has been
operational in the production of blood products for
the past decade and has been a privately held
company since 2001. With approximately 130
employees, they produce products that are made
into Serum Albumin and IV products. The company's
focus is Biologics and Contract Manufacturing
serving multiple applications.
{KISTLER-MORSE}
Problem
The plant was expanding and the company wanted
to look at new technologies. Due to the FDA's data
collection requirements for 21 CFR Part 11, they
wanted a way to check the data that the batch
control system is acquiring to verify the system's
accuracy. The data was currently being......
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Approximate Pages: 5 (250 words per double-spaced page)
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