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Lecture 2 Pharma

The document discusses pharmaceutical microbiology and aspects related to ensuring sterile and safe pharmaceutical products. It covers topics like endotoxin detection, environmental monitoring, microbial detection systems, and quality control microbiology. It also mentions some key pharmacopeias that develop standards for drug manufacturing.

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37 views7 pages

Lecture 2 Pharma

The document discusses pharmaceutical microbiology and aspects related to ensuring sterile and safe pharmaceutical products. It covers topics like endotoxin detection, environmental monitoring, microbial detection systems, and quality control microbiology. It also mentions some key pharmacopeias that develop standards for drug manufacturing.

Uploaded by

NIMRAH
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Microbiological aspects

of pharmaceutical
industry
LECTURE 2
Introduction
Pharmaceutical Microbiology involves the study of the specific microorganisms associated
with the development, scale-up, and manufacture of pharmaceuticals and the subsequent
minimizing or elimination of the number of microorganisms in a process environment. Excluding
microorganisms and microbial by products like exotoxin and endotoxin from water and other
starting materials is a key component of quality control in pharmaceutical manufacturing to
ensure finished pharmaceutical products are sterile.

Other aspects of pharmaceutical microbiology include the research and development of anti-
infective agents, the use of microorganisms to detect mutagenic and carcinogenic activity in
prospective drugs, and the use of microorganisms in the manufacture of pharmaceutical
products like insulin and human growth hormone.
Pharmaceutical Microbiology
Endotoxin Detection and Testing
Environmental Monitoring and Testing
Microbial Detection Systems
Mycoplasma Detection and Testing
Endotoxins
Endotoxins are heat-stable toxins associated with the outer membranes of gram-negative
bacteria. Due to the severe consequences of an infection, an injectable healthcare product such
as a vaccine or intravenous solution must be sterile or free of live bacteria, but the
manufacturing process to kill any bacteria can result in the release of endotoxin into the
product. Just as with a bacterial infection or sepsis, if sufficient endotoxin gets into our
bloodstream or spinal fluid we can develop fever, shock, and organ failure. In extreme cases, it
can even result in death.

Therefore, injectables or implantables, products that come in contact with the bloodstream or
spinal fluid, are tested for sterility (the absence of live bacteria) as well as endotoxin. Testing for
endotoxin helps ensure safe pharmaceuticals are delivered to patients.
Environmental monitoring and testing equipment are used to test for surface and airborne
contaminants within pharmaceutical cleanrooms and other controlled environments. The data is
often used for regulatory compliance and manufacturing protocols for safety and QA.
Microbial Detection Systems perform an important role in assuring pharmaceutical products are
free from unwanted bacteria, yeast, mold and other microbial contaminants before leaving the
manufacturing facility. Recently, rapid microbial detection systems have been developed to
speed the detection process and allow for the release of products to the market in a faster
manner.

Control of the environment and the attendant testing which is required in facilities where
pharmaceutical products are manufactured is a key component of Good Manufacturing
Practice.
Quality Control microbiology 
Quality Control microbiology is an essential function of the pharmaceutical industry. Drug
manufacturers must thoroughly test materials, processes, equipment, techniques, environments
and personnel in order to ensure their final products are consistent, safe, effective and
predictable.
The guidelines to ensure quality, safety, sterility & accurate potency of the drug during its
development cycle is followed through existing pharmacopeias.
A Pharmacopeia is an organization that develops and publishes standards for manufacturing
prescription and over-the-counter medicines as well as other healthcare products.
Pharmacopeias
Three major pharmacopeias throughout the world include
The United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.) and the
Japanese Pharmacopoeia (JP).
Each of these organizations has their own set of standards, however the International
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) is working to facilitate international harmonization in the interpretation and
application of technical guidelines and requirements for the pharmaceutical industry.

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