JAKARTA - Indonesian biofarmasi company, PT Etana Biotechnologies Indonesia (Etana) continues to show its strong commitment to producing high-quality local biological products that comply with the guidelines for Good Manufacturing Practices (CPOB) from the Food and Drug Supervisory Agency (BPOM).
Quality Leader Etana Rakhmat Budi Yuwono emphasized that the company always strives to meet strict requirements to produce quality and safe products for patients.
"Etana is committed to serving patients by providing high-quality, affordable, and innovative biological products. To ensure that the resulting drugs always meet the requirements and have high quality, and are safe for patients, the company designs and implements a comprehensive Quality System," said Rakhmat, in a written statement, quoted on Saturday, July 13.
The Quality System includes the principles of CPOB and Quality Risk Management. Continuous evaluation is carried out to ensure the effectiveness of this system. This is very important so that the purpose of using drugs can be achieved properly.
"All drug manufacturing activities must be in accordance with the Quality System that is set and must always maintain its suit with the CPOB and applicable regulations," said Rakhmat.
Rakhmat added that the products produced always meet the quality standards that have been set, even the same or better than imported products.
Quality assurances are not only about ensuring finished products meet standards through a series of tests, but also about building quality into the product itself. These include initial materials, packaging materials, production and quality control processes, infrastructure, equipment used, and personnel involved," he said.
Furthermore, Rakhmat said that Etana also faces challenges in maintaining production quality such as rapid technological advances, complex manufacturing processes, adherence to increasingly strict rules, data integrity and security, knowledge and skill gaps and quality risks. However, Etana has prepared several efforts to anticipate this.
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Various efforts such as improving expertise and experience, being flexible and quickly adapting to technological changes, building an innovation culture, improving effective collaboration and communication, learning and sustainable development, advancing and encouraging quality culture, proactive risk management and maintaining and improving compliance and integrity," he concluded.
Through these various steps and efforts, Etana has proven her commitment to producing high-quality biological products. This not only shows the company's ability to produce quality medicines but also Etana's commitment to always place patient needs and safety as a top priority.
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