Internship Report

Quality Control of Pharmaceutical Products at PT Meprofarm

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Established in 1973 by Ir. Wanne Mardiwidyo, PT Meprofarm is an Indonesian pharmaceutical company
based in Bandung that always prioritizes achieving quality in producing products. Meprofarm has 2 main
production facilities which are MEPRO-1 and MEPRO-2. MEPRO-1 focuses on producing solid dosage
forms of non-beta lactam, beta lactam penicillin, and beta lactam cephalosporin. Meanwhile, MEPRO-2
produces oral liquid, external liquid, and semisolid dosage forms of non-beta lactamase. The Quality
Control (QC) department is supervised by the Quality Operation under the Manufacturing Operations. As
an essential part of the good manufacturing practices (GMP), QC functions to ensure that every aspect of
the drug manufacturing process, starting from the raw material until the finished product meets the
safety, efficacy, and quality standards of medicines. During the internship period, the works assigned
were given by the Raw and Packaging Materials, Stability, and Finished Good (Microbiology) divisions. In
a way to ensure the quality of drugs from its raw materials until the finished products, QC has the
responsibility to create procedures and specifications to perform the tests and evaluation, also making
reports of the test results as evidence. The scope of works given in the internship were revising and
updating documents of Starting Material Specification and Starting Material Test Method according to
the current Pharmacopeias and certificate of analysis (CoA), revising and updating the SOPs of climatic
chamber devices and personnel limitation access into bilingual format, creating documents of Stability
Study Protocol and Stability Study Report, and processing raw data and creating trend line graph then
making the trend analysis report of environmental monitoring for microbial contamination. All the works
given were performed well and to conclude, the QC department has implemented the GMP in all aspects
of their work and environment.

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Availability

Detail Information

Series Title

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Call Number

PHA 22-007

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)

Pharmaceutical industry
Quality control
stability
Good Manufacturing Practice (GMP)
aw and packaging materials
finished good (microbiology)

Specific Detail Info

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Statement of Responsibility

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Other version/related

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