Laporan Praktik Kerja Profesi Apoteker Farmasi Industri di PT Kalbe Farma, Tbk. Cikarang

Abstract

Background: The pharmaceutical industry is a business entity that possesses the required license, in accordance with regulatory provisions, to engage in the manufacturing of medicines or medicinal raw materials. These activities must adhere to the Good Manufacturing Practice (GMP) guidelines so that the produced medicine is fit for its intended use, meets the requirements stated in the marketing authorization document, and does not pose any harmful risks. Therefore, pharmacists, who play a crucial role in the pharmaceutical industry, must possess adequate qualifications, knowledge, experience, and skills to ensure the implementation of GMP complies with specified requirements. Objective: This Pharmacist Professional Practice Program aims to enable prospective pharmacists to understand their roles, functions, and responsibilities within the pharmaceutical industry, as well as to grasp the implementation of Good Manufacturing Practice (GMP) in the pharmaceutical industry. The PKPA activity also provides the author with practical preparation and experience for performing pharmaceutical work in the industry through the application of GMP at PT Kalbe Farma, Tbk. Cikarang. Summary: The PKPA activity at PT Kalbe Farma, Tbk. Cikarang included understanding: Standard Operating Procedures (SOPs); the production flow of pharmaceutical dosage forms; in-process testing and necessary sampling for the testing and release of finished products; the importance of production operational management concerning Plant Cycle Time and Overall Equipment Effectiveness (OEE); the creation of a Quality Risk Management (QRM) Contamination Control document; the development of a Clean Up Set Up Check List required during the line clearance process; the creation of a module on line clearance; the handover of materials and finished products between production and logistics; and the use of the Werum application. Conclusion: After completing the PKPA activity at PT Kalbe Farma, Tbk. Cikarang, it can be concluded that the pharmacist is the key personnel in the pharmaceutical industry, specifically in the areas of production, quality control, and quality assurance. It is also confirmed that the pharmaceutical industry PT Kalbe Farma, Tbk. Cikarang has implemented every aspect of GMP well.