Internship Report

Endotoxin Testing and Environmental Monitoring Analysis of Quality Control in Kalbio Global Medika

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Kalbio Global Medika (KGM) which is a subsidiary of PT Kalbe Farma is one of the primary
pharmaceutical companies in Indonesia specializing in the manufacture of sterile parenteral drug
products which was built up in 2014. The quality control (QC) department of KGM is divided into five
which are Raw material, Microbiology, Finished goods and intermediate, Compliance and Test item
control. In the manufacture of pharmaceutical drug products, especially in the production of sterile
pharmaceutical products, microbiological and sterility testing as part of the QC testing plays a crucial
role to ensure the safety of both the materials used and its finished products. Endotoxin testing and
environmental monitoring (EM) analysis are two of the most crucial testing performed in the
microbiology of QC department. With the aim of ensuring the absence of pyrogens in both the
materials and products as well as evaluating the microbiological quality of critical areas ensuring the
aseptic conditions are properly maintained during manufacturing operations, endotoxin testing by
gel clot method and EM analysis are routinely performed. Result obtained from endotoxin testing of
a water for injection (WFI) sample, media and buffer for erythropoietin, media and buffer for
efepoietin and raw material which is citric acid monohydrate shows a successful result with the
absence of clot in the sample and presence of clot in the positive product control (PPC). An out of
specification (OOS) result of grade D filing room is obtained which requires a further OOS
investigation to find its root cause, for the EM analysis result. Therefore, it is significantly crucial to
understand ways in preventing contamination and risks of microbial growth in both sterile and
non-sterile manufacturing processes.

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Availability

Detail Information

Series Title

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Call Number

PHA 22-006

Publisher

i3L, Jakarta : i3L, Jakarta., 2022

Collation

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Language

English

ISBN/ISSN

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Classification

NONE

Content Type

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Media Type

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Carrier Type

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Edition

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Subject(s)

Quality control
sterile pharmaceutical products
endotoxin testing
environmental monitoring analysis
out of specification

Specific Detail Info

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Statement of Responsibility

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