Laporan Praktik Kerja Profesi Apoteker Industri Farmasi di PT Kimia Farma Tbk Plant Banjaran

Abstract

Background: The Pharmaceutical Industry is a business entity that has a permit in accordance with the provisions of statutory regulations to carry out activities in the manufacture of medicines or medicinal substances. Good Medicine Manufacturing Method, hereinafter abbreviated to CPOB, is a method of manufacturing medicines and/or medicinal substances which aims to ensure that the quality of the medicines and/or medicinal substances produced is in accordance with the requirements and intended use. CPOB Certificate is a legal document which is proof that the Pharmaceutical Industry or facilities have met CPOB standards in making Medicines and/or Medicinal Ingredients (BPOM, 2024). Objective: To understand and study the application of Good Medicine Manufacturing Methods, to find out the role and responsibilities of pharmacists in the Pharmaceutical Industry, especially as those responsible for production, quality assurance and quality control, to find out the general description and participate directly in activities taking place at PT Kimia Farma Tbk Plant Banjaran. Method: This report was carried out using a qualitative approach including collecting information related to the implementation of good medicine manufacturing methods, the roles and responsibilities of pharmacists in the pharmaceutical industry, as well as a general description and direct participation in activities taking place at PT Kimia Farma Tbk Plant Banjaran. Results: Prospective pharmacists have gained an understanding of the application of Good Medicine Manufacturing Methods, the roles and responsibilities of pharmacists in the Pharmaceutical Industry, as well as a general overview and participate directly in activities taking place at PT Kimia Farma Tbk Plant Banjaran. Conclusion: PT Kimia Farma Tbk Plant Banjaran has implemented CPOB aspects well in every aspect and series of production processes which include quality system aspects; personnel; buildings and facilities; equipment; production; good drug storage and delivery; quality control; self-inspection quality audit and supplier approval audit; product complaints and recalls; documentation; outsourcing activities; as well as qualification and validation. This is proven by obtaining a CPOB certificate.

Background: The Pharmaceutical Industry is a business entity that has a permit in accordance with the provisions of statutory regulations to carry out activities in the manufacture of medicines or medicinal substances. Good Medicine Manufacturing Method, hereinafter abbreviated to CPOB, is a method of manufacturing medicines and/or medicinal substances which aims to ensure that the quality of the medicines and/or medicinal substances produced is in accordance with the requirements and intended use. CPOB Certificate is a legal document which is proof that the Pharmaceutical Industry or facilities have met CPOB standards in making Medicines and/or Medicinal Ingredients (BPOM, 2024). Objective: To understand and study the application of Good Medicine Manufacturing Methods, to find out the role and responsibilities of pharmacists in the Pharmaceutical Industry, especially as those responsible for production, quality assurance and quality control, to find out the general description and participate directly in activities taking place at PT Kimia Farma Tbk Plant Banjaran. Method: This report was carried out using a qualitative approach including collecting information related to the implementation of good medicine manufacturing methods, the roles and responsibilities of pharmacists in the pharmaceutical industry, as well as a general description and direct participation in activities taking place at PT Kimia Farma Tbk Plant Banjaran. Results: Prospective pharmacists have gained an understanding of the application of Good Medicine Manufacturing Methods, the roles and responsibilities of pharmacists in the Pharmaceutical Industry, as well as a general overview and participate directly in activities taking place at PT Kimia Farma Tbk Plant Banjaran. Conclusion: PT Kimia Farma Tbk Plant Banjaran has implemented CPOB aspects well in every aspect and series of production processes which include quality system aspects; personnel; buildings and facilities; equipment; production; good drug storage and delivery; quality control; self-inspection quality audit and supplier approval audit; product complaints and recalls; documentation; outsourcing activities; as well as qualification and validation. This is proven by obtaining a CPOB certificate.

Keywords: Industry, CPOB, Pharmacist