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

Abstract

Background: The pharmaceutical industry is a business entity that has obtained permits in accordance with statutory regulations to engage in the manufacture of drugs or drug substances. These activities must adhere to the Good Manufacturing Practice guidelines. The GMP guidelines encompass all aspects of production and quality control, including the receipt of materials, production, repackaging, labeling, relabeling, quality supervision, approval, storage, and distribution of drugs, as well as related monitoring. Objective: The objective of the Pharmaceutical Industry Pharmacist Professional Work Practice at PT. Dankos Farma is to understand the duties and responsibilities of pharmacists in the pharmaceutical industry, especially regarding quality control, to comprehend the implementation of Good Manufacturing Practice in the pharmaceutical industry, particularly at PT. Dankos Farma, and to gain an overview and directly participate in the ongoing activities at PT. Dankos Farma. Summary: This Pharmacist Professional Work Practice was conducted from March 12, 2024, to May 15, 2024, with primary placement in the Quality Control Department, specifically in Quality Control Compliance, and scheduled to undergo online induction into other departments. Activities in this section included studying transfer methods of analysis, method verification, preparation of matrix samples, method verification protocols, analytical worksheets, method verification reports, and method analysis preparation. Additionally, it involved learning about the parameters for verifying analytical methods, including accuracy, precision (repeatability, intermediate precision), specificity, limit of quantification (LOQ), linearity, and system suitability tests. Conclusion: After conducting the Pharmacist Professional Work Practice at PT. Dankos Farma, the following conclusions can be drawn: Pharmacists in the pharmaceutical industry have significant duties and responsibilities, especially as quality control supervisors. Pharmacists are responsible for sampling and testing starting from raw materials, packaging materials, intermediate products, finished products, to ensure they meet specifications. PT. Dankos Farma has effectively implemented all aspects of GMP, including quality management, personnel, buildings and facilities, equipment, production, proper storage and distribution of drugs, quality control, self-inspection and quality audits, complaint handling, product recalls, documentation, outsourcing activities, and qualifications and validations. The Quality Control Compliance Department at PT. Dankos Farma conducts method validation/verification and method transfer.