| dc.description.abstract | Background: The Pharmacist Professional Work Practice (PKPA) is one of the
implementations of pharmacist competency training in the pharmaceutical industry.
This PKPA was conducted at PT Daewoong Biologics Indonesia, a
biopharmaceutical company focusing on cell-based therapies, particularly stem
cells, secretomes, and natural killer cells.
Objectives: To provide direct experience in applying Good Manufacturing Practice
(GMP) for facilities processing cell- and human tissue–based products, as well as
to broaden the knowledge of prospective pharmacists regarding production
processes, quality control, quality assurance, and management systems within the
pharmaceutical industry.
Methods: Direct observation of production and non-production activities,
document review, and discussions with field supervisors.
Results: PT Daewoong Biologics Indonesia has implemented all aspects of GMP
Regulation No. 18/2022, including quality system, personnel, facilities, equipment,
processing flow, storage, distribution, quality control, documentation, as well as
qualification and validation. This implementation ensures product quality, safety,
and consistency in every manufactured batch.
Conclusion: The PKPA program at PT Daewoong Biologics Indonesia provides
comprehensive insights for prospective pharmacists on the application of modern
biopharmaceutical industry standards. This experience is expected to enhance
competence, skills, and readiness of pharmacists in facing professional challenges
in the pharmaceutical industry, especially in the field of cell-based therapies in
Indonesia. | en_US |
