Laporan Praktik Kerja Profesi Apoteker Industri Farmasi di PT Darya-Varia Laboratoria Tbk Plant Citeureup

Abstract

Background: Pharmacists are healthcare professionals authorized to perform pharmaceutical work and play a crucial role in ensuring the quality and safety of medicines. The pharmaceutical industry is required to implement Good Manufacturing Practices (GMP), therefore pharmacy students need to understand its application through the Pharmacist Professional Work Practice (PKPA) program. Objective: This activity aims to understand the implementation of Good Manufacturing Practices (GMP), identify the roles and responsibilities of pharmacists in quality assurance, quality control, and production, as well as to gain direct experience in industrial operations at PT Darya-Varia Laboratoria Citeureup. Method: The PKPA program was conducted on-site at PT Darya-Varia Laboratoria Tbk, Citeureup Plant, Bogor, West Java, from January 6 to February 28, 2025. Activities were carried out every weekday, Monday to Friday, from 07:30 AM to 04:00 PM. Results: PT Darya-Varia Laboratoria Tbk Citeureup Plant has implemented all aspects of Good Manufacturing Practices (GMP) in accordance with BPOM RI Regulation No. 7 of 2024. The implementation covers quality systems, personnel, buildings and facilities, equipment, production, storage and distribution, quality control, documentation, self-inspection, outsourcing, and qualification and validation. All production processes are conducted according to standard procedures under the supervision of pharmacists responsible for production, quality control, and quality assurance to ensure consistent product quality, safety, and efficacy. Conclusion: PT Darya-Varia Laboratoria Tbk Citeureup Plant has consistently implemented all aspects of Good Manufacturing Practices (GMP), including quality management, personnel, buildings and facilities, equipment, sanitation and hygiene, production, quality control, self-inspection and audit, complaint handling, product recall, documentation, qualification, and validation throughout its manufacturing processes. Pharmacists play a vital role in ensuring product quality and safety through their responsibilities in production, quality control, and quality assurance. The PKPA program provides pharmacy students with direct experience and a deeper understanding of GMP implementation and the pharmacist’s role in the pharmaceutical industry.