Indonesia Strengthens CPOB Certification as Key Standard for Medicine Quality Assurance

The quality of medicines is a non-negotiable aspect of the health service system in Indonesia. Behind every drug circulating in the market lies a series of production, testing, and supervision processes aimed at ensuring the product is safe, effective, and of consistent quality before it is used by the community. In Indonesia, this standard is known as Good Manufacturing Practice (CPOB). This certification, issued by the Food and Drug Supervisory Agency (BPOM), serves as a reference for the pharmaceutical industry in implementing a production system that meets quality requirements at every stage of drug manufacture. The implementation of CPOB encompasses not only the production process but also facility management, raw material quality control, cleanliness of the production environment, human resource competence, documentation, and distribution systems. The entire process is designed to minimize the risk of contamination, production errors, and variations in product quality. With the growth of the pharmaceutical and biopharmaceutical industries, the implementation of good production standards is also considered crucial for strengthening Indonesia's competitiveness. Beyond supporting the availability of domestic health products, this standard is one of the requirements for pharmaceutical products to comply with regulations in various countries. Efforts to enhance the quality of pharmaceutical manufacturing are continuously undertaken by various industry players. PT Selatox Bio Pharma is one such example, having recently obtained CPOB certification from BPOM and inaugurated its biopharmaceutical manufacturing facility in Cikarang, West Java. This certification signifies that the company's production facilities and quality management systems meet the standards set by regulators. Its manufacturing facilities are equipped with sterile production areas, advanced manufacturing technology, and a quality control system that oversees every stage, from raw material receipt to production processes, laboratory testing, and product distribution. Joh Young Hoon, CEO of Selatox, stated that this achievement is part of the company's commitment to building a production system that prioritizes quality. "The acquisition of CPOB certification from the Indonesian Food and Drug Supervisory Agency (BPOM) is an important achievement for us. This certification confirms that our manufacturing facilities and quality management systems have met the established standards," he said at the facility's inauguration. He added that the company will continue to invest in human resource development and the application of manufacturing technology to support the growth of the biopharmaceutical industry in Indonesia. The government also continues to encourage an increase in domestic drug production capacity as part of efforts to strengthen national health resilience. Agus Tjahajana Wirakusumah, Special Staff for Health System Transformation at the Ministry of Health, noted that strengthening the pharmaceutical industry is a key step toward achieving health sector independence. "In line with the health system transformation agenda, the government continues to encourage the realization of national health resilience through strengthening domestic production capacity, technology mastery, and increasing collaboration between the government, industry, and educational institutions. The presence of manufacturing facilities like PT. Selatox Bio Pharma is expected to support Indonesia's pharmaceutical independence while improving the competitiveness of the national health industry," he stated. Meanwhile, Head of BPOM RI, Taruna Ikrar, assessed that the implementation of CPOB standards is a vital indicator in maintaining the quality of pharmaceutical products manufactured in Indonesia. "We congratulate PT Selatox Bio Pharma on the inauguration of the biopharmaceutical manufacturing facility and the achievement of Good Manufacturing Practices (CPOB) certification. This achievement reflects the company's commitment to meeting international standards related to safety, quality, and efficacy, and is an important step in strengthening the pharmaceutical and biopharmaceutical industries in Indonesia," he said. For the public, standards like CPOB may not be directly visible when taking medicine. However, these standards play a crucial role in ensuring that every product reaching patients is produced through a controlled, consistent process, and meets safety and quality requirements. As the national biopharmaceutical industry develops, the implementation of good production standards is expected to not only increase confidence in domestic health products but also strengthen Indonesia's ability to develop a more independent and competitive pharmaceutical industry on a global scale. Source: VOI English