Laporan Praktik Kerja Profesi Apoteker Industri Farmasi di PT. Novell Pharmaceutical Laboratories Jakarta Barat

Abstract

Background: The pharmaceutical industry is a licensed business entity that engages in the production of medicines. To ensure that the quality of medicines produced meets the requirements and is suitable for their intended use, Good Manufacturing Practices (GMP) are required, which serve as a reference for every pharmaceutical industry in the production of medicines. In order for the medicines produced to be distributed, they must first obtain a distribution licence. A marketing authorisation is a form of registration approval for distribution in Indonesia. Objective: This report aims to determine the roles, functions, and responsibilities of pharmacists in the pharmaceutical industry, specifically in the Business Development department at PT. Novell Pharmaceutical Laboratories, as well as to understand the implementation of Good Manufacturing Practices (GMP) guidelines at PT. Novell Pharmaceutical Laboratories. Method: The method used was observation and direct practice by students in PKPA activities carried out from 3 January to 28 February 2025 at PT. Novell Pharmaceutical Laboratories. Conclusion: Pharmacists at PT. Novell Pharmaceutical Laboratories have implemented CPOB aspects well and have roles, functions, and responsibilities based on their positions, including Business Development, Product Development, Quality Control, Quality Assurance, Product Planning and Inventory Control (PPIC), Training, and Analytical Development Export and Dossier. Specifically in the Business Development division, pharmacists have roles, functions, and responsibilities related to new product development and drug registration.