CPOB 2024 - PRODUKSI (Bag. Pertama). WAJIB Di ketahui oleh Mahasiswa Farmasi dan Praktisi Industri

Why can a small error in the drug production process lead to a national tragedy? In 2022, Indonesia was shocked by the case of Atypical Acute Progressive Kidney Disease (AGDA), which claimed hundreds of children due to contamination with hazardous materials in syrup. This incident served as a reminder that drug quality is not solely determined by formulation or laboratory test results, but also by how the entire production process is carried out in a disciplined, controlled manner, and in accordance with the principles of Good Manufacturing Practices (GMP). Through this video, I invite you to thoroughly understand Chapter 5 Production in the 2024 GMP Standard, one of the most crucial parts of the pharmaceutical industry's quality system. The discussion focuses not only on regulatory theory but also connects each requirement with real-world practice based on more than three decades of experience working in the national and multinational pharmaceutical industries. We will learn how a drug product is systematically manufactured, from the receipt of raw materials, storage in the warehouse, weighing, processing, and packaging, to its final release to the market and patient use. This video also reviews several important changes in the 2024 GMP compared to the previous edition, including increased regulatory attention to raw material supply chain integrity, supplier traceability, excipient control, supplier audits, quality risk management, and initial material testing. This video is part of the Industrial Pharmaceutical Management learning series, which discusses regulatory implementation, quality systems, GMP, validation, qualification, product development, Quality Risk Management, and best practices in the modern pharmaceutical industry.