| dc.description.abstract | Background: The pharmaceutical industry plays a strategic role in ensuring the
availability of safe, effective, and high-quality medicines in accordance with
regulatory standards. To achieve this, the implementation of Good Manufacturing
Practice (GMP) is a fundamental requirement in every stage of production.
Pharmacists, as pharmaceutical professionals, hold a crucial responsibility in
ensuring that all processes within the pharmaceutical industry comply with GMP
principles, from raw material procurement to finished product distribution.
Therefore, practical understanding and hands-on experience are essential through
the pharmacist’s professional work practice in the pharmaceutical industry.
Objective: The pharmacist’s practice at PT Kalbio Global Medika was carried out
to broaden knowledge and understanding of the roles, functions, and
responsibilities of pharmacists in the pharmaceutical industry, particularly in the
areas of production, quality assurance, and quality control through the
implementation of GMP standards.
Summary: The pharmacist’s practice was conducted from February 3 to March 28,
2025, at PT Kalbio Global Medika, a biopharmaceutical company focusing on the
development and production of biological medicines with modern facilities
compliant with GMP standards. During the practice, observations and in-depth
learning were carried out regarding the quality management system, production
facilities, personnel, and documentation supporting regulatory compliance. In
addition, a cleaning validation protocol was developed as part of the application of
GMP principles in the pharmaceutical industry setting. Overall, the pharmacist’s
practice provided a comprehensive overview of pharmaceutical practice in the
industry and emphasized the pharmacist’s role in ensuring product quality.
Conclusion: The pharmacist’s practice at PT Kalbio Global Medika provided
practical experience and a deeper understanding of GMP implementation in the
pharmaceutical industry. This practice highlighted the strategic role of pharmacists
as those responsible for production, quality control, and quality assurance in
supporting the availability of safe, high-quality, and compliant pharmaceutical
products. | en_US |
