Laporan Praktik Kerja Profesi Apoteker Industri Farmasi di PT. Kalbio Global Medika Cikarang

Abstract

The pharmaceutical industry plays a crucial role in producing safe, effective, and high-quality medicines to meet public health needs. Biotechnology-based pharmaceutical manufacturing has become increasingly important, producing innovative products such as biosimilars, monoclonal antibodies, and recombinant proteins. The implementation of Good Manufacturing Practice (GMP), or Cara Pembuatan Obat yang Baik (CPOB), is essential to ensure that these products meet strict quality, safety, and efficacy standards. GMP covers all aspects of production, including quality management systems, personnel qualifications, facility and equipment requirements, sanitation and hygiene, validated production processes, in-process and final quality control, comprehensive documentation, deviation handling, and product recall systems. In biopharmaceutical manufacturing, GMP compliance is critical to controlling variability, maintaining product consistency, and safeguarding patient safety. The integration of biotechnology and GMP has transformed the pharmaceutical industry, enabling the development of advanced therapies while ensuring regulatory compliance and global quality standards.