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 There
is a constant challenge to attain a higher degree of environmental
monitoring and control for pharmaceutical, biotechnology and medical
device companies in order to avoid product contamination. These
industries are under mounting pressure to conform to evolving USP
and cGMP regulations. Industry trade associations including the
Parenteral Drug Association (PDA), Institute for International Research
(IIR), International Society for Pharmaceutical Engineers (ISPE),
and Barnett International have established task forces and published
guidelines for these same manufacturers. This has created a need
for products and services that provide the means to comply with
regulatory and industry standards.
Since 1987 when the FDA Guideline on Aseptic
Processing was issued, there has been an increased focus on environmental
monitoring as it relates to the potential contamination of pharmaceutical
products. Not much has been documented concerning why the regulatory
bodies have increased their focus in this area. However, there has
not been a significant increase in product considered non-sterile
due to environmental contamination. Furthermore, there is no direct
relationship between the level of environmental contamination and
the risk to product. The evidence of the regulatory bodies' heightened
interest in environmental monitoring comes from the increasing number
of FD-483's and Warning Letters issued over the past several years.
The Institute for Advanced Professional Studies (Center for Professional
Advancement) cGMP and Quality Issues for Biopharmaceuticals reported
that in 1998 environmental monitoring accounted for 21% of all 483
observations; and in 1999 accounted for 14% of all observations,
and 34 warning letters. Additionally, it has not only effected aseptic
facilities, but non-sterile drugs, as well.
Health care manufacturers are now seeking solutions
for their environmental monitoring operations that are meaningful,
manageable, and defendable. Technology-based software systems that
can manage sensitive information, and comply with the regulations
and guidelines have become essential tools for the industry. One
of the greatest challenges faced by manufacturers is the large volume
of data that is generated. Trending, reviewing, and assessing the
data must be done in a timely manner. The automated system must
also stand up to your interpretation of 21 CFR Part 11, for both
electronic records and electronic signature.
For years, companies have struggled with manual
systems, spread sheets, custom developed applications, and LIMS.
Few systems have been designed, developed, and tested to specifically
manage and report environmental monitoring data, and at the same
time address the regulatory requirements and industry guidelines
established for the manufacturer. Our Microbiology Information Management
System (MIMS) is one such system.
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