ECS Brands Ltd. Earns ICH Q7 Certification
Providing guidance on Good Manufacturing Practice (GMP) for active pharmaceutical ingredients (APIs)
Broomfield Colorado May 15, 2023 – ECS Brands Ltd. manufacturing facility was recently awarded International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q7 Certification, which provides guidance on Good Manufacturing Practice (GMP) for active pharmaceutical ingredients (APIs). Being ICH Q7 certified offers several benefits to pharmaceutical manufacturers.
“We are thrilled to achieve this important ICH Q7 certification, which represents our ongoing commitment to meeting and exceeding industry standards,” said Arthur Jaffee, CEO of ECS Brands. “At ECS Brands, we are dedicated to providing our customers with the highest quality products and services, and this certification demonstrates our unwavering commitment to delivering on that promise.”
About ICH Q7 Certification
It’s important to note that ICH Q7 certification specifically focuses on APIs and not finished pharmaceutical products. Manufacturers of APIs who achieve and maintain ICH Q7 certification demonstrate their dedication to quality and compliance, which positively impacts the entire pharmaceutical industry and patient care.
Here are some key advantages of being ICH Q7 Certified:
Compliance with International Standards: ICH Q7 certification ensures compliance with globally accepted GMP standards. It demonstrates that the manufacturer follows established quality management systems, manufacturing processes, and controls for API production. This compliance enhances the reputation of the manufacturer and facilitates international trade.
Regulatory Compliance: Many regulatory authorities, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan, consider ICH guidelines when assessing the quality of pharmaceutical products. Being ICH Q7 certified helps manufacturers meet regulatory requirements, which can expedite product approvals and market access in multiple countries.
Quality Assurance: ICH Q7 emphasizes the implementation of comprehensive quality systems and risk-based approaches to ensure consistent product quality, safety, and efficacy. Certification helps manufacturers establish robust quality control measures, ensuring that APIs are consistently produced according to defined specifications. This leads to reliable and safe products for consumers.
Supply Chain Integrity: ICH Q7 emphasizes the control and traceability of raw materials and intermediates used in API manufacturing. Certification ensures that suppliers are qualified, materials are properly tested, and appropriate documentation is maintained throughout the supply chain. This enhances transparency, reduces the risk of counterfeit or substandard materials, and ensures the integrity of the entire manufacturing process.
Continuous Improvement: ICH Q7 promotes a culture of continuous improvement and quality risk management. Manufacturers are encouraged to evaluate and optimize their processes, identify potential risks, and implement corrective actions. This focus on continual improvement leads to enhanced process efficiency, reduced variability, and increased overall product quality.
Market Competitiveness: ICH Q7 certification gives manufacturers a competitive edge in the global pharmaceutical market. It signifies their commitment to high-quality manufacturing practices, which is valued by regulatory authorities, customers, and partners. Being ICH Q7 certified can attract new business opportunities, partnerships, and collaborations.
Patient Safety: Ultimately, the implementation of ICH Q7 guidelines is aimed at ensuring patient safety by maintaining consistent quality standards throughout the API manufacturing process. By adhering to these guidelines, manufacturers contribute to the overall safety and efficacy of pharmaceutical products, benefiting patients worldwide.
About ECS Brands
ECS Brands® is a full service supplier, co-manufacturer, turnkey product developer and innovation partner that differentiates the customer experience through quality and service. ECS Brands is known for its dedication to transparency, and rigorous safety, quality and potency testing conducted in its certified NSF cGMP, USDA Organic, ICH Q7, verified non-GMO project, and FDA registered manufacturing facility. In addition to ECS Brands, the company’s other business segments include ECS Health, a clinical research partner and full-service product development platform, and ECS Wholesale. Additionally, ECS is developing disruptive and sustainable technologies across multiple industries including: cutting-edge solutions in health sciences, modern agriculture, green manufacturing, with an emphasis on universal sustainability to mitigate the negative human impact on the environment.
For more information about ECS Brands and its products, visit the company’s website at www.ecsbrands.com.
Arthur Jaffee CEO, ECS Brands Arthur@ecsbrands.com
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