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

Abstract

Objective: This Pharmacist Professional Work Practice (PKPA) is carried out with an effort to increase students' understanding of the roles and responsibilities of pharmacists in the pharmaceutical industry, provide insight and skills for students, learn Good Manufacturing Practices (CPOB) and their application in the pharmaceutical industry, and prepare students for the world of pharmaceutical work in the pharmaceutical industry. Methods: The Professional Pharmacist Work Practice (PKPA) of PT Pharos Indonesia Industry was carried out on September 9, 2024 ̶ November 13, 2024. PKPA activities at Pharos Indonesia include placement in Quality Assurance (QA) and to have knowledge about other departments in Pharos Indonesia. Results: Quality Assurance (QA) is an action to ensure that the systems that support production are as specified. At PT Pharos Indonesia, this control includes the implementation of CPOB and GMP (Good Manufacturing Practice) systems. The QA department is responsible for structuring the drug manufacturing process and implementing policies to produce products according to specifications. The QA department at PT Pharos Indonesia is divided into two sections, namely quality system (QS) and qualification, calibration, and validation. There are six sub-sections in the quality system, including quality audit, document control, product quality assessment (PMP), product approval, change control, and complaints and deviations. Quality audits are conducted to assess the implementation of CPOB and are conducted on a planned and unannounced basis. The Document Center maintains archives and organizes all divisions' documentation, while product quality reviews are conducted once a year to ensure consistency and specifications. The product clearance process ensures that products meet specifications before they are released from quarantine. Qualification and validation are very important in CPOB. Qualification involves facilities, systems and equipment, while validation focuses on processes. All procedures and support systems must be validated. Calibration is also arranged to ensure the conformity of machines to standards. QA is responsible for qualification, validation and calibration at PT Pharos Indonesia. Conclusion: PT Pharos Indonesia has implemented aspects of CPOB well in every aspect and series of production processes.