FDA certified factory
Certified factory. FDA establishment identifier : 3017983754.
API manufacturer. certified producer of drugs according to US regulations.
ISO 13485:2016 is an internationally recognized standard that outlines the requirements for a quality management system specifically designed for medical devices. This standard covers various aspects of the manufacturing process, including design, development, production, installation, and servicing of medical devices. For cosmetics factories that also manufacture or supply medical devices used in cosmetic procedures, complying with ISO 13485 can help them establish robust quality management systems, ensuring the safety and efficacy of their medical products. However, it is essential to note that ISO 13485 specifically targets medical devices and not cosmetic products themselves. For cosmetics factories that solely produce cosmetic products, ISO 22716:2007 (as mentioned earlier) is more relevant as it specifically addresses the Good Manufacturing Practices (GMP) for the cosmetics industry.
ISO 22716:2007 is an internationally recognized standard that sets forth guidelines for Good Manufacturing Practices (GMP) in the cosmetics industry. For cosmetics factories, it serves as a comprehensive framework to ensure the consistent and safe production of cosmetic products. The standard covers various critical aspects such as personnel training and hygiene, facility design and maintenance, equipment calibration and cleaning, formulation processes, quality control measures, and meticulous documentation. By adhering to ISO 22716, cosmetics factories demonstrate their commitment to producing high-quality, safe products that meet regulatory requirements. This standard plays a crucial role in enhancing product quality, minimizing potential risks to consumers, and promoting confidence in the cosmetics industry.
ISO 9001:2015 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) in various industries, including manufacturing, services, and processes. For a cosmetics factory, ISO 9001:2015 provides a systematic approach to achieving consistent product quality and customer satisfaction. By adhering to this standard, the cosmetics factory can establish and maintain effective processes for product development, formulation, production, and quality control. ISO 9001:2015 focuses on customer requirements, risk-based thinking, continual improvement, and evidence-based decision-making, which are all vital elements in the cosmetics industry. Implementing ISO 9001:2015 in a cosmetics factory can enhance efficiency, minimize defects, and ensure compliance with applicable regulations and customer expectations, ultimately leading to improved product quality and customer trust.