Laporan Praktik Kerja Profesi Apoteker Industri Farmasi di PT. Dankos Farma Jakarta Timur

Abstract

Background: Good Manufacturing Practices (GMP), or Cara Pembuatan Obat yang Baik (CPOB) in Indonesia, are essential for ensuring the quality, safety, and efficacy of pharmaceutical products. Pharmacists play a strategic role in implementing these practices within the pharmaceutical industry, particularly in areas such as quality assurance and validation. To prepare future pharmacists for these responsibilities, practical exposure to CPOB implementation is crucial. Objective: This Pharmacist Professional Work Practice (PKPA) aimed to provide hands-on experience and enhance understanding of the pharmacist’s role in the pharmaceutical industry, with a focus on CPOB implementation. The program was conducted at PT. Dankos Farma, Jakarta, from August 19 to October 23, 2024. The objective was to develop practical skills related to quality assurance systems, particularly in Product Quality Review (PQR) and Cleaning Validation. Method: The PKPA was conducted in the Quality Assurance (QA) Department, specifically in the QA PQR and Cleaning Validation units. Activities included participating in company induction sessions outlining departmental functions, applying the "KUA Lima Dasar" as part of CPOB compliance, and undertaking tasks such as understanding relevant SOPs, compiling Product Quality Review reports, reviewing cleaning validation/verification documents, and performing batch record data entry. Results: Throughout the program, participants were actively involved in essential QA operations, gaining a deeper understanding of documentation systems, CPOB requirements, and validation practices. Exposure to real-world QA processes provided participants with insights into maintaining product quality through structured evaluations and accurate record-keeping. Conclusion: The implementation of CPOB at PT. Dankos Farma is well-integrated into its quality assurance operations. This PKPA experience enriched participants' knowledge and practical capabilities, especially in conducting Product Quality Reviews and Cleaning Validations, equipping them for future roles in the pharmaceutical industry.