Laporan Praktik Kerja Profesi Apoteker Industri Farmasi di PT. Phapros Tbk. Semarang

Abstract

Background: Good Manufacturing Practices (GMP) are industry standards to ensure the quality, safety, and efficacy of pharmaceutical products in compliance with regulatory requirements. Pharmacists play a crucial role in quality assurance, production process validation, and regulatory compliance. Therefore, prospective pharmacists must acquire knowledge and skills in GMP implementation within the pharmaceutical industry. Objective: This Pharmacist Professional Work Practice (PKPA) aims to provide direct insight into the roles and responsibilities of pharmacists in the pharmaceutical industry, particularly in GMP implementation at PT. Phapros Tbk. The program also seeks to equip participants with hands-on experience in quality assurance, validation, and documentation systems within the industry. Method: PKPA was conducted over two months, during which participants were assigned to the Quality Assurance (QA) Department. Participants were involved in production process validation, supplier audits, pharmaceutical waste management, as well as HVAC system and water treatment implementation to ensure product quality. Results: The QA department plays a crucial role in ensuring all production stages comply with the applicable standards. Participants gained experience in identifying production deviations, implementing Corrective and Preventive Actions (CAPA), and optimizing production procedures to improve efficiency and product quality. Conclusion: PT. Phapros Tbk. has successfully implemented GMP aspects throughout its production processes. This PKPA experience provided valuable insights and essential skills for prospective pharmacists in understanding quality assurance systems within the pharmaceutical industry. Keywords: Pharmaceutical industry, PT. Phapros Tbk., Quality Assurance, Validation, CAPA, GMP.