Page 19 - Microbiology in workplace
P. 19
GMP Training – Microbiology in the Workplace by www.gmpsop.com
Water and other critical services control
Environmental control
Personnel control
We will look at each of these issues in turn.
GOOD TO KNOW - MICROBIOLOGY "FACTS" AND MANUFACTURING CONTROL
Microbiological testing is far from absolute.
Negative test results may merely indicate insensitivity of the test.
Microbiological contamination is not evenly dispersed throughout a lot or
sample of product.
Finding a contaminant in one sample and not in another does not discount
the findings of the initial sample results.
Other organisms may mask the presence of certain organisms when
identification procedures are performed.
Control of starting materials
Starting materials must always be handled and stored in a manner to prevent
contamination. Some important handling and storage rules include:
Store starting materials clean, dry, and if necessary, cold.
Store starting materials off the ground, and under cover.
Always keep containers sealed when not in use.
Be alert to damaged packages.
Never use dirty or wet sampling or measuring equipment.
Starting materials themselves may contain potentially contaminating micro-
organisms. QC testing takes into consideration the origin of the mater al,
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