Laporan Praktik Kerja Profesi Apoteker Industri Farmasi di PT. Konimex

Abstract

Background: Pharmacists play a crucial role in maintaining the safety, quality, and efficacy of pharmaceutical preparations. One of the pharmacist's duties is to ensure the quality of pharmaceutical preparations produced by production facilities. Production facilities must have a responsible pharmacist assisted by assistant pharmacists and/or pharmaceutical technicians. Production facilities can include pharmaceutical industries, raw material industries, traditional medicine industries, and cosmetics factories. Pharmaceutical production must comply with the provisions of the Good Manufacturing Practices (GMP) guidelines to ensure product quality meets applicable standards. Based on this description, the Pharmacist Professional Internship (PKPA) in the pharmaceutical industry is crucial for introducing prospective pharmacists to the world of pharmacy in the industrial sector. Purpose: The Pharmacist Professional Internship (PKPA) at PT. Konimex aims to provide students with an understanding of the functions, roles, and responsibilities of pharmacists in the pharmaceutical industry, as well as the application of aspects of Good Manufacturing Practices (GMP) in the pharmaceutical industry, specifically at PT. Konimex. Summary: Pharmacist Internship (PKPA) The Pharmacist Internship (PKPA) at PT. Konimex Pharmaceutical Industry was conducted from April 7 to May 30, 2025. This PKPA was conducted to gain firsthand insight into the roles, functions, and responsibilities of pharmacists in the pharmaceutical industry and to understand the implementation of Good Manufacturing Practices (GMP) at PT. Konimex. The PKPA activities at PT. Konimex began with a one-month induction in each division, followed by a one-month assignment to each division. These specific tasks included the technical division, analytical development, quality assurance, quality control, and validation. Conclusion: The role of pharmacists in the pharmaceutical industry is to be responsible for key personnel in the pharmaceutical industry, namely production, quality control, and quality assurance. Pharmacists must understand quality risk management in accordance with Good Manufacturing Practice guidelines. The implementation of Good Manufacturing Practice guidelines at PT. Konimex is appropriate. In every stage of its production process, which includes aspects of the pharmaceutical industry's quality system, personnel, buildings and facilities, equipment, production, good drug storage and delivery practices, quality control, self-inspection, complaints and product recalls, documentation, outsourcing activities, and qualification and validation. PT. Konimex also applies the principles of ICH Q8, ICH Q9, and ICHQ10.