To meet regulatory expectations, the role of the
microbiologist is essential. To add to this, the input from quality assurance personnel,
engineers, and process specialists is required. Whilst there is a continuing
need for monitoring of the environment and conducting standardized laboratory
tests, industrial pharmaceutical microbiology has moved a great deal in the
past decade to embrace microbiological audits; rapid microbiological methods;
conducting risk assessments, both proactive in terms of minimizing
contamination and reactive, in terms of addressing microbial data deviations;
and also ensuring that processes meet ‘quality by design’ principles.
This is the introduction to an article by Tim Sandle
for the Journal of GxP Compliance (a special edition devoted to Microbiology).
The reference is:
Sandle, T. (2017) Pharmaceutical Microbiology:
Current and Future Challenges, Journal of
GxP Compliance, 21 (4): 1- 5: http://www.ivtnetwork.com/article/pharmaceutical-microbiology-current-and-future-challenges
The article, which looks at key factors set to
influence the future of pharmaceutical microbiology, can be accessed
here.
The special edition contains the following articles:
Approach
for the Qualification of a Pharmaceutical Facility Autoclave by Tim Sandle
This paper discusses the key criteria for autoclave
cycle development; the use of a matrix approach for qualifying an autoclave and
the key parameters (thermometric and biological) for evaluating the success of
the validation.
Establishing
a Library of In-House Isolates by Jeanne Moldenhauer
For many companies, there have been questions on why
an in-house library is necessary and how to set up this library of isolates.
This paper describes the basis for needing this type of library as well as a
way to establish this type of library.
Microbial
Identification Strategy for Pharmaceutical Microbiology by Tim Sandle
This article addresses these points and provides a
basis of the microbiologist in each pharmaceutical or healthcare organization
to develop a microbial identification strategy.
Developing
or Updating your Environmental Monitoring Program to Meet Current Regulatory
Expectations by Jeanne Moldenhauer
Since the early 1990’s there has been an increased
emphasis on the need for environmental monitoring by many different regulatory
agencies. Learn what a total environmental monitoring program is to see where
yours can improve.
Setting
Environmental Limits for Mold Contamination by Jeanne Moldenhauer
Many individuals come into contact with airborne
mold on a daily basis. In some facilities, employees travel between buildings
on a campus going through the environment and are exposed to airborne
contaminants.
Posted by Dr. Tim Sandle
