Laporan Praktik Kerja Profesi Apoteker Industri di PT. Kimia Farma Sungwun Pharmacopia Cikarang

Abstract

Objective: This Pharmacist Professional Internship (PKPA) is carried out with an effort to improve students' understanding of the roles and responsibilities of pharmacists in the pharmaceutical industry, provide students with insight and skills, learn Good Manufacturing Practices for Active Drug Raw Materials (CPBBAOB) and their application in the pharmaceutical industry, and prepare students to enter the world of pharmaceutical work in the pharmaceutical industry. Methods: The Industrial Pharmacist Professional Internship (PKPA) of PT. Kimia Farma Sungwun Pharmacopia was implemented on September 9, 2024 – November 13, 2024. PKPA activities carried out at PT. Kimia Farma Sungwun Pharmacopia include placement in Quality Assurance (QA) and gaining an understanding of other departments at PT. Kimia Farma Sungwun Pharmacopia Results: Quality Assurance is an action to ensure that the system that supports production is in accordance with that specified in PT. Kimia Farma Sungwun Pharmacopia, this control includes the implementation of the CPBBAOB and GMP (Good Manufacturing Practice) systems. The QA department is responsible for compiling the drug manufacturing process and implementing policies to produce products according to specifications. The QA department at PT. Kimia Farma Sungwun Pharmacopia includes the quality system (QS) and qualification, calibration, and validation. There are six sub-sections in the quality system, including quality audits, document control, product quality assessments, product releases, change control, and complaints and deviations. Qualification and validation are very important in CPBBAOB. Qualification involves facilities, systems, and equipment, while validation focuses on the process. All supporting procedures and systems must be validated. Calibration is also regulated to ensure that the machine complies with standards. The QA department is responsible for qualification, validation and calibration at PT. Kimia Farma Sungwun Pharmacopia. Conclusion: PT. Kimia Farma Sungwun Pharmacopia has implemented CPBBAOB aspects well in every aspect and series of its production processes.