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

Abstract

Background: The pharmaceutical industry is a business entity that has a permit by statutory provisions to carry out activities in the manufacture of medicines or medicinal substances. These activities must follow the guidelines for Good Medicine Manufacturing Practices (CPOB). Pharmacists have an important role in the pharmaceutical industry. A pharmacist must have good qualifications, knowledge, experience and skills to ensure that the implementation of CPOB will run by the specified requirements. Objective: This Pharmacist Professional Work Practice is carried out with the aim that prospective pharmacists can understand the roles, functions and responsibilities of pharmacists in the pharmaceutical industry and understand the application of Good Medicine Manufacturing Practices (CPOB) in the pharmaceutical industry. PKPA activities also provide provisions and practical experience for the author to carry out pharmaceutical work in the industry through the application of CPOB in the PT pharmaceutical industry. Dankos Farma Jakarta. Summary: PKPA activities at PT. Dankos Farma is validating the computerized system used at PT. Dankos Farma. Validation of computerized systems is made based on orders or systems tailored to user needs and is based on documented risk assessments and impacts on CPOB. Computerized systems should be evaluated periodically to ensure that the system is in valid condition and meets CPOB provisions. Computer system validation will have an impact on the data produced because computer systems have a role in processing and producing data so computer system validation is needed in the pharmaceutical industry. Conclusion: After carrying out PKPA activities at PT. Dankos Farma, it can be concluded that pharmacists are key personnel in the PT pharmaceutical industry. Dankos Farma, namely in the fields of production, quality control and quality assurance (following CPOB 2018), prospective pharmacists understand the application of CPOB in the pharmaceutical industry, especially at PT. Dankos Farma. Pharmaceutical industry PT. Dankos Farma has implemented every aspect of CPOB well starting from the quality system, personnel, buildings and facilities, equipment, production, good methods of storing and shipping medicines, quality control, self-inspection, complaints and product recalls, documentation, outsourcing activities, to qualification and validation.