Compliance with cGMP still remains a struggle for many in the Dietary Supplement industry, even years after the cGMP rules have become a necessary component of doing business.
Is your manufacturing system helping or hindering your compliance? Do you have multiple systems, loosely (or not at all) integrated? Is compliance harder, more costly, or more difficult than it should be? Your business software has an important role to play in streamlining your processes, managing your master batch records, enforcing your procedures while enabling your compliance.
Sustainable Dynamics has partnered with developer, New Strategies, to deliver an integrated industry specific solution for Dietary Supplements manufacturers. Leveraging from the knowledge and understanding the developer has for building solutions using Dynamics AX for the pharmaceutical and life sciences industry, Sustainable Dynamics has worked with New Strategies to configure an ‘out-of-the-box’ solution aimed directly at the regulatory, and cGMP compliance needs, of manufacturers of Dietary Supplements. Without the additional complexity demanded in Pharma, but providing the extended regulatory support often missing in products that simply service the food sector, our solution specifically zeros in on the needs of the Dietary Supplement Manufacturer.
Your ERP SHOULD support your business requirements to:
- Manage the procurement of raw materials
- Prevent unsafe products from entering the supply chain
- Track and monitor individual product units
- Enforce compliance to local regulatory requirements throughout the production process
- Automate work processes for quality management
- Integrate work flows between departments or divisions
- Drive your production and laboratory equipment maintenance activities (preventative/corrective maintenance, spare parts etc)
What is AX for Dietary Supplements?
Microsoft Dynamics AX is a fully featured ERP software product developed by Microsoft and sold through a channel of independent Value Added Resellers (VARs). The VAR community presents to ERP buyers with one of the best ERP systems available, in their toolkit.
However, Dynamics AX, offers extensive functionality for organizations from single site to global, from manufacturers to servicers, from public sector, to food, to oil and gas. With such breadth and depth on offer, it is critical that VARs like Sustainable Dynamics stake a position in the marketplace. We need to know who we are, what we are good at, and what type of companies are the best fit for what we offer. We need to know our customers. Only then can we truly offer a differentiated, value-added service.
Being specialized means building up a reservoir of talent with expertise in aligned industries so that when we work with our customers, we understand the nature of their business. It also means either becoming, or partnering with, Independent Software Vendors (ISV’s) that have made the effort to build industry “Intellectual Property” into a tangible software add-on (a product) that complements, supplements, and fills in the gaps of the core ERP system to meet the more unique needs of an industry. ISV products reduce the amount of custom modifications that invariably get implemented as companies try to turn their ‘out of the box’ generic ERP into a “best of breed” industry focused package.
At Sustainable Dynamics, we have chosen to build our expertise in the Food and Beverage, Dietary Supplement and Natural Products. We have chosen these industries because we have a good skill base around process and mix mode manufacturing and have a good depth of understanding across our tem of the needs of these businesses. But we have also chosen these industries because of the importance SUSTAINABILITY in these industries. As a company, it is our aim to bring the element of Sustainability measurement and management to the world of ERP and we believe this message will resonate particularly well in our chosen field.
The ISV solution produced by New Strategies aims at building out Dynamics AX functionality around the needs of manufacturers working in highly regulated industries. This includes, but is not limited to, needs in pharmaceutical and life sciences, food & beverage, dietary supplements, chemicals and defense. The features of the product complement the functionality available in AX. The New Strategies solutions are built in the same programming language as Dynamics AX, so that the user interface is identical. You cannot tell that you are working in a different ‘product’. This is important as it means that there is no need to learn a ‘different program’. The solutions are designed to run seamlessly on top of Dynamics AX. As AX is designed to leverage the core Microsoft products from SQL to Excel, so AX for Dietary supplements is designed to leverage the core Dynamics AX and give an elegant, custom feel, to the product on your desktop.
New Strategies products are Certified for Microsoft Dynamics AX 2012, which means they have passed both the rigorous product testing required for the badge, as well as the commercial benchmarks related to in-field usage. At Sustainable Dynamics we are proud to be one of the few global authorized resellers of New Strategies products.
Minimize expensive customizations and implementation challenges. AX for Dietary Supplements anticipates the requirements for best practice industry compliance, thereby reducing the need for costly custom modifications that send some ERP projects off the rails. Industry-tailoring reduces implementation complexity, and provides assurance that the solution will support the way you have to do business.
Meet business and industry needs with a single integrated solution. AX for Dietary Supplements combines Microsoft Dynamics AX, defined as an ERP Leader by Gartner (Link to the Gartner Report), with industry-specific solutions and capabilities such as Manufacturing Execution System, Advanced Quality Management and Enterprise Asset Management. Rich Life Sciences expertise and best practices fuel successful system implementations that can go all the way to FDA validation.
Comply with GxP Guidelines 21 CFR Part 11, and EU Annex 11. Achieve full compliance with international guidelines and regulations. Drive consistent compliance by tracking GMP operations such as lot status, work order processing, batch releases and quality control approvals.
Implement Advanced Quality Management. Integrated quality assurance controls include non-conformances management, quarantine, quality orders, sampling plans, reduced/skip testing, acceptance criteria, certificates of analysis, and batch records. Activity-based product costing enables careful monitoring for both direct and indirect costs.
Promote best practices across your value chain GxP. – compliant development, manufacturing, inventory and supply chain management support rework activities, co/by-products, contract manufacturing, inprocess quality, container/sub-lot management, skill management for manufacturing, and quality and project management.
Inventory and Warehouse Management
- Item approval workflow includes automated, selective blocking for unapproved items.
- Container/sub-lot management offers full batch and container traceability, including batch lifecycle and status changes, secured by electronic signature.
- Inventory journals approval is secured by electronic signature.
- Manage unit conversions by batch according to the actual batch assay and potency.
- Manage approved customer lists (ACL) by item, batch, and country.
- Reserve batches that align precisely with batch attributes and batch specifications defined by item and customer.
- Secure Qualified Person approvals before shipment with electronic signatures.
- Generate approved vendor (AVL) and manufacturer (AML) lists, backed by quality control integration for incoming goods.
- Ensure consistency with a structured vendor/manufacturer qualification process.
Advanced Quality Management
- Quality order approval workflow equips users with a graphical interface, multiple levels of review, approval and escalation secured by electronic signature, and a conditional release process.
- Robust integration connects stability studies and clinical and analytical services with project management.
- Streamline sample management, reduce tests, and produce accurate sampling plans based on a statistical approach.
- Generate Certificates of Analysis by item and item/customer.
- Test criteria based on mathematical calculations with multiple steps in compliance with US, EMA, Latin American and Japanese regulatory requirements.
Advanced Quality Management
- Complete Dispensing and Filling module includes integration with scales with serial or RJ45 connections.module includes integration with scales with serial or RJ45 connections.
- Assay management includes theoretical and actual batch assay, along with automatic recalculation/rescaling and reservation of components and ingredients. Ensure continuous precision with scale management, calibration, and maintenance.
- Manage reworking and reprocessing activities.
- Generate production Batch Record.
- Save time and reduce paper-based activities by managing master batch records within the system, automatically linked to the formula version.
GMP Plant Maintenance
- Manage preventive and corrective equipment maintenance with multi-level object control.
- Preventive and ad-hoc work orders integrate with Materials Resource Planning and equipment availability.
- Monitor and optimize costs, consumption, and availability with spare parts management and documentation.
- Full traceability of maintenance activities includes workflows and electronic signatures.Calculate full costs for items, including direct and indirect costs.
Activity-Based product costing
- Calculate full costs for items, including direct and indirect costs.
- Capabilities include full alignment with sales and manufacturing forecasts, cost center budgets (quality, purchasing, indirect manufacturing, etc.), and product standard costs.
Compliance with 21 CFR Part 11 and EU Annex 11
- Electronic signature includes limited validity period and user lock-out if a certificate is repeatedly violated, as required by 21 CFR Part 11, Paragraphs 11.10, 11.200.
- Use extensible, dynamic record-level security and permissions to define access rights and functions for a user group and document status.
What is a dietary supplement?
From the FDA
A dietary supplement is a product intended for ingestion that contains a “dietary ingredient” intended to add further nutritional value to (supplement) the diet. A “dietary ingredient” may be one, or any combination, of the following substances:
- a vitamin
- a mineral
- an herb or other botanical
- an amino acid
- a dietary substance for use by people to supplement the diet by increasing the total dietary intake
- a concentrate, metabolite, constituent, or extract
Dietary supplements may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. Some dietary supplements can help ensure that you get an adequate dietary intake of essential nutrients; others may help you reduce your risk of disease.
Vasilios Frankos is former director of the Division of Dietary Supplement Programs at the Center for Food Safety and Applied Nutrition. Hear him discuss Dietary Supplements.