Dietary Supplements - Risk, Compliance and Quality Management Solutions
| 
The dietary supplements industry is diverse, as are the number and types of products marketed as dietary supplements. The U.S. dietary supplement market is rising at double-digit rates thanks to increased consumer focus on health and trends geared toward greater globalization and financing.
With the proliferation of products including vitamins, minerals, botanicals, and other nutraceutricals, growing competition, and increased importation of lower cost ingredients, it follows that there is a growing range of public health concerns presented by the manufacturing practices for dietary supplements, especially for those Vitamins/Minerals/Supplements (VMS) with over-the-counter or prescription requirements.
FDA warning issues have increased due to bioterrorism, increased import volumes, unsubstantiated label claims, increased internet sales and media exposure in recent years over such issues as the Ephedra and allergen incidents. Therefore, a comprehensive system of controls (21 CFR 110, regulated by CFSAN and DSHEA) is necessary to ensure public safety, and for the manufacturers, to ensure growth and profit.
Although other countries, such as Canada and Australia, classify supplements as drugs requiring even submission approval, the FDA in 2007, issued the Current Good Manufacturing Practice (CGMP) requirements for Dietary Supplements, requiring that proper cGMP controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations. Adherence to the standards for cGMP for dietary supplements will help ensure the quality of the dietary supplement and that the product is packaged and labeled as mandated by the FDA. The establishment of strict supplier, complaints, and adherence to other cGMP requirements of this final rule will help to prevent the occurrence of quality issues and possible regulatory actions.
Pilgrim Software has created a platform of fully integrated, web-based compliance solutions that ensure compliance with the dietary supplements industry requirements and enables companies to substantiate product safety. Built on industry best practices and more than a decade of domain expertise, Pilgrim Software’s Risk, Compliance & Quality Platform offers a powerful, fully integrated solution for managing your quality system.
Pilgrim's 21 CFR Part 11-compliant solutions help manufacturers of Dietary Supplements:
- Enhance their quality system while reducing the cost of quality and ensuring industry requirements are being fully met
- Effectively catalog ingredients, process, or label and branding change management
- Enforce SOP training, policies, and procedures while verifying employee education and training
- Maintain comprehensive document control for labeling, supplemental facts, packaging, laboratory and manufacturing control procedures
- Establish an efficient, closed-loop system for receiving, processing, tracking, and solving customer complaints along with filing AERs (Adverse Events Reports)
- Monitor suppliers and incoming materials to ensure conformance with appropriate standards and that the dietary supplements meet the identity, purity, strength, and composition
- Facilitate internal audits for self-preservation, facility standards, and laboratory controls
- Schedule recurrent calibration and maintenance for key equipment lifecycle management
- Manage nonconformances and implement corrective and preventative actions
- Enhance high-level enterprise-wide oversights and reduce management liability
The Enterprise Risk, Compliance and Quality Management Platform
Pilgrim Software provides a centralized, enterprise–wide, fully web-based solution for managing adverse event reporting, change control management, complaint handling, corrective and preventive actions, document control and content management, engineering drawing control and collaboration, employee certification and training, equipment maintenance/calibration, internal and external audits, nonconformance management, process management, regulatory submissions, risk management, SOP enforcement, and supplier quality management.
This powerful platform enables you to manage product safety while complying with regulatory requirements; reduce manufacturing and operational costs; increase overall productivity; and, improve customer satisfaction by managing the critical processes that govern your organization.