Praktik Kerja Profesi Apoteker Industri di PT Kalbio Global Medika Cikarang

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.