Quality is a necessity in today’s marketplace for companies that want to stay competitive and build consumer trust. This is especially true for the nutraceuticals industry, where product safety is crucial to brand success.
Regulatory requirements for nutraceuticals vary from country to country. In the US, finished dietary supplements, as well as their ingredients, are regulated by the FDA. Manufacturers and distributors are prohibited from marketing products that are misbranded. They must also ensure that the products are safe and follow FDA good manufacturing practices (GMP).
Any violations in manufacturing and labeling can lead to an FDA inspection. Even the smallest errors can have potentially lethal consequences that can not only lead to product recalls and millions in lost revenue, but also ruin a company’s reputation.
Among the many challenges that exist to ensure consistent product safety and compliance, here are the three main elements that must be addressed to ensure proper controls and an effective quality system.
Top 3 Considerations for Nutraceutical Companies
- Supplier Management - One of the biggest challenges for a nutraceutical company is supplier quality management. With an ever expanding global supply chain, companies source ingredients and other inputs from a variety of suppliers and vendors. There must be a system in place to collaborate with all suppliers to ensure that good manufacturing practices are in place and being adhered to. Companies must also ensure that ingredients are being sourced correctly and ethically, as well as keep track of any non-conformances.
- Visibility - Paper based and other siloed document and quality management systems lack the transparency needed to address today’s business needs. Data maintained in Excel spreadsheets and disconnected systems are difficult to extract and use for real-time trending and reporting. With safety being such a high priority in the nutraceutical industry, having real-time visibility into quality, production, and testing data allows companies to be proactive in addressing issues before they occur.
- Connected Processes - Quality processes are not meant to be completed in silos. Product and process issues must be analyzed holistically as one issue can impact another. For example, it’s important to link customer complaints to risk management activities for re-assessment and also to CAPA to ensure completion of any actions. Connected processes reduce compliance gaps and ensure an efficient and effective quality system.
These were the challenges facing one of Veeva’s current customers working in the vitamin, mineral, and herbal supplements industry. New Chapter Inc., a wholly-owned subsidiary of Proctor & Gamble, was using a paper-based and disconnected on-premise software for its quality processes. This made it difficult for the team to manage quality and documents efficiently and adhere to regulatory and compliance requirements.
Using Veeva QualityOne to Transform Quality
New Chapter turned to Veeva for a unified QMS and document management solution that would integrate with its parent company’s existing quality system. With Veeva QualityOne application, the company is able to deploy, manage documents, and quality with increased efficiency, traceability, and compliance.
With QualityOne’s supplier management solution, New Chapter was able to greatly improve its interactions with suppliers and vendors. It eliminated blind spots in the supply chain processes, increased supplier accountability, and helped to mitigate risk.
The company also leveraged the complaint management solution to quickly resolve any customer issues, investigate, and link to other quality processes such as CAPA and audits. This has helped the company decrease the lag in identification of nonconformance and safety issues that are addressed through customer complaints. Veeva QualityOne provided the company with a cohesive and collaborative platform to manage external contractors, meet FDA compliance and safety regulations, and achieve quality success.
Safety and compliance is a critical issue faced by many companies in the nutraceutical industry. Veeva QualityOne is committed to improving the way organizations manage their quality processes and content.
To learn more, join us at the 2018 Veeva Quality Summit on June 5th 2018 in Cincinnati, OH. This event is designed for manufacturing quality professionals and their IT partners in the nutraceuticals industry, as well as from other regulated manufacturing industries such as CPG, Cosmetics and F&B.