Laporan Praktik Kerja Profesi Apoteker Industri di PT. Pharos Indonesia Jakarta

Abstract

Objective : Pharmacist Professional Work Practice (PKPA) in the pharmaceutical industry is carried out with an effort to improve the insights, skills, and understanding of prospective pharmacists regarding the roles, duties, and responsibilities of pharmacists in the production process, quality control, and quality assurance in the pharmaceutical industry, especially in the application of Good Manufacturing Practices (CPOB) in accordance with applicable regulations. Methods: PKPA implementation is carried out through an observational and participatory approach. Students are placed directly in the Quality Assurance (QA) unit and follow the entire process flow related to the quality management system, starting from the inspection of raw materials, production processes, packaging, validation, documentation, to self-inspection. During the practice, students were actively involved in internal audit activities, monitoring the production process, evaluating laboratory test results, as well as managing complaints and product recalls. In addition, students also gained a comprehensive understanding of the organisational structure of pharmaceutical companies, the functions of each department, and coordination between work units in order to ensure the quality of pharmaceutical products. Results : The implementation of PKPA shows that PT Pharos Indonesia has implemented a quality management system optimally in accordance with the latest edition of the CPOB standard. The implementation of the quality system in the company includes aspects of personnel, production facilities, equipment, sanitation, and documentation, as well as procedures that support the quality assurance of drug products. The role of pharmacists in pharmaceutical companies has proven to be crucial in ensuring the quality, safety, and efficacy of drugs through direct involvement in all stages of the production process and quality control. In addition, students get a real picture of the problems faced in the production process of the pharmaceutical industry and how solutions are applied systematically and according to regulations. Conclusion : The implementation of this PKPA is that the pharmacist profession has an important responsibility in ensuring the implementation of an effective and sustainable pharmaceutical industry quality system, in accordance with the principles of CPOB. Through direct involvement in the production process and quality assurance, pharmacists are able to ensure that every pharmaceutical product produced meets the established quality standards and is safe for use by the public.