Over the years, the U.S. has remained
the world’s biggest market for pharmaceutical products and the global leader in
biopharmaceutical research. In fact, the massive
U.S. pharmaceutical industry accounts for about 80 percent of all research
and development in biotechnology in the world. The United States National
Institute of Health claims that there are approximately 140,000 clinical trials
underway for pharmaceutical products awaiting FDA approval, which the
Pharmaceutical Research and Manufacture of America (PhRMA) claims to have an
annual value of over $67 billion.
The markets for generics, biologics and
over-the-counter (OTC) drugs have continued to grow and become increasingly
competitive. The research sector, alone, has recorded an average annual growth
of 28% since 2,000. The success
of pharmaceutical products is largely dependent on competition in price,
product quality, and safety and efficacy. The continued favorable support from
the U.S. government in biomedical research, ultimate scientific and research
base, and the innovative biotechnology sector make it the ideal home for the development
of the pharmaceutical industry.
However, the massive expenditure
directed toward research may compel some manufacturers to rush the release of
their products, leading to grave repercussions. For instance, the number of
drug recalls in the pharmaceutical industry increased drastically between 2008
and 2009, from 426 to 1,742, mostly due to microbial contamination. A
manufacturer suffers immeasurable damage when their drug product is recalled,
including the loss of product sales, reduced consumer confidence, tarnished
brand and company name, and legal proceedings, in most cases. Fortunately,
there is increased
access to rapid microbiology testing systems that streamline production and
promote efficient laboratory practices for increased throughput and product
safety.
Quality control is a critical function
in the pharmaceutical industry. It is essential for drug manufacturers to
scrutinize their test materials, equipment, processes, environments, personnel
and techniques to ensure that the safety, consistency, effectiveness and
predictability of their final products. However, multiple factors have
necessitated the delivery of speedy test results, including regulatory
agencies, corporate quality initiatives, and the need to save on resources
(money, space and personnel).
Rapid microbiology testing systems
are applicable in a wide range of quality control operations including
in-process monitoring, purified and process water testing, environmental
monitoring, manufacturing process design, raw materials and excipients testing,
and investigations and final products release testing. The latter is the most
critical test due to the immediate impact that any undetected contamination
could have in the consumer population. Rapid microbiology systems provide
timely results that are either similar or better than those obtained in
traditional methods. The use of an incubation phase also ensures that less time
is spent to obtain results, compared to 14 days using conventional methods, in
addition to making them easier to interpret and compare.
Other benefits
of the rapid method include: reduced plant downtime, decreased warehouse
space and raw material costs; fast final-product release; shorter product
release cycle times; labor and time savings in the lab during manufacturing;
risk reduction in manufacturing; reduced cycle times in terms of reduced
backorder and product losses; risk reduction in manufacturing; increased
business and production flexibility; increased capabilities in manufacturing
and product development; robust understanding of manufacturing processes;
proactive control as seen in the shift from quality control to quality
assurance procedures; immediate detection and correction of contamination;
instant cleaning validation; and better protection of consumers and company
image.
Generally, rapid microbiology testing
systems enable the pharmaceutical industry to perform many tests using less
time, money and effort, in order to ensure the delivery of safe products.
Contact Biolumix for more
information about rapid
microbiology testing for the pharmaceutical industry.
Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
http://www.mybiolumix.com/
https://plus.google.com/103841943418192727689/
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
http://www.mybiolumix.com/
https://plus.google.com/103841943418192727689/
