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Hello, everyone!
My name is Rajesh Gupta.
I'm a Pharmaceutical Microbiologist
currently working as
a consultant with
the Biologics Quality and
Regulatory Consultants.
I am doing consulting in
the quality and regulatory
aspects of biological products.
In this talk, I'm
going to go over
Building Microbiological Quality
During Manufacture of Medicines.
0:27
My presentation would cover
the importance of the microbiological
quality of medicines and
how it is controlled in
various types of medicines
including biological products.
I would go over briefly on
building microbiological
quality of
sterile and
non-sterile medicines.
Then I would focus on
microbiological testing
and controls used for
the testing to ensure the
reliability of results.
In the end, I would go over
the selection of
microorganisms for
ensuring the reliability
of the methods used in
the detection of bacteria
and mold in medicines and
how the culture stocks of
these microorganisms should
be prepared and stored.
1:12
Moving to the microbiological
quality of medicine.
There is a risk of
contamination of
medicines with microbes
during manufacture.
The risk of the presence of
microbes in medicines is
clinically important for
the safety and efficacy
of these medicines.
The microbes can have a
direct impact on health,
including diseases due
to these microbes and
death in a short period.
Further, the medicine
with the microbes may not
be effective in treating
the disease for which
it is being taken.
These microbes may have
long-term effects
also such as cancer,
autoimmune, and other
chronic diseases.
Contamination of medicines with
microbes can affect the
stability of the medicines with
the impact on biological
activity, chemistry,
and pharmacology
of these medicines
which may cause side effects.
Therefore, it is essential to
control microbes during
manufacturing to
mitigate the risk due to
microbes in medicines.
