The U.S. Food and Drug Administration (FDA) recently announced plans to update the Dietary Supplement Health and Education Act of 1994 (DSHEA). The potential DSHEA changes have prompted concerns about the business impacts of additional regulatory rigor. To be ahead of the competition when changes occur, nutraceutical manufacturers should consider implementing a Laboratory Information Management System (LIMS), which can address many of the concerns. Also, consider the risks related tonotimplementing a LIMS: analyze the monetary, time, and opportunity costs of maintaining your status quo. Compliance is often easier and less expensive with a LIMS. Before we get into the specifics, let’s look at the background of these regulatory changes.
DSHEA currently takes a reactive stance toward dietary supplements or nutraceuticals. If the FDA takes action and initiates enforcement under DSHEA as it exists today, it’s because a nutraceutical product has demonstrated a risk to consumers, not because the manufacturer couldn’t prove that the product was safe. This reactive stance was the approach formerly taken by the FDA about food, before enacting the Food Safety and Modernization Act (FSMA) of 2011. FSMA was the direct result of a deadly Salmonella outbreak caused by contaminated peanuts from one manufacturing facility, which resulted in more than 1000 product recalls. FSMA mandated a shift to proactive prevention of incidents versus a reactive, rapid response. Historical patterns indicate that changes to DSHEA will also take the FDA’s role in regulating dietary supplements from reactive to proactive.
The FDA needs to be able to quickly and accurately evaluate nutraceutical products when safety questions arise. With increased consumption and competition in the supplement market, consumers may decide to only purchase from nutraceutical manufacturers that can prove their safety and quality. Having a LIMS will provide a competitive advantage when the proposed changes to DSHEA take place.
Why do you need a LIMS? Consider this example: it’s very common to source ingredients from different suppliers. If you do so, how do you know if the same amount of active compound is in each lot from those different suppliers? How do you standardize your formulation from batch to batch? These are some of the consumer-focused questions that the changes to DSHEA may address and that a LIMS can help you answer. However, there are many other situations, beyond increasing consumer confidence, in which a LIMS can benefit your nutraceutical lab.
CSols, Inc. has broad experience with LIMS implementations in many regulated labs and we can help you find the right answers to all of these questions for your nutraceutical lab.
Nutraceutical companies must comply with 21 CFR Part 11 if they use electronic records and signatures in any form. A properly validated LIMS facilitates the use of electronic records and ensures compliance with 21 CFR 11. Having easily accessible electronic records makes lab operations more efficient.
A LIMS supports rapid traceability of raw material, manufacturing intermediates, and final products. The current DSHEA legislation is reactive, so if someone gets sick from a nutraceutical product, the FDA needs information as quickly as possible to identify the cause. Final product batch genealogy is an important manufacturing initiative that can address issues of adulteration or contamination proactively, and in which a LIMS also plays a role.
A well-validated LIMS increases data integrity and reduces compliance risks. Good data integrity makes it easier to comply with GMP and GLP as laid out in the Good Automated Manufacturing Practices (GAMP) documentation from the International Society for Pharmaceutical Engineering.
Implementing a LIMS is a good way to avoid a bad FDA audit. A LIMS can help nutraceutical manufacturers find the right data, faster and more efficiently than by sorting through spreadsheets or paper files. Your staff won’t be tied up with data retrieval or reporting because a LIMS makes these things quick and easy, improving lab data management. Any changes to DSHEA will more than likely increase the number of FDA audits, and if you do get audited, you’ll be well prepared.
Automating processes and integrating instruments with a LIMS can increase productivity, decrease human error, and facilitate data analysis and reporting. A LIMS also provides timely feedback from quality control to manufacturing, so you get better data with which to optimize your manufacturing process efficiency and lower costs. The ability to replace multiple systems or paper records with a LIMS lowers overall IT costs, as well.
A LIMS lowers operating costs for nutraceutical manufacturers by:
A LIMS automates many data management tasks and removing human error increases data integrity. Both data integrity and validation are vital to remaining compliant. A properly validated LIMS proves to your clients that data integrity is a priority, which will raise consumer confidence in the quality of your product. You’ll be able to create reliable CoAs with standardized ranges of ingredients. Customers will have easy access to those CoAs to further increase their confidence in your business. The automation inherent in a LIMS can help ensure that ingredients have been properly verified for labeling purposes and provide a measure of product quality.
If your nutraceutical lab doesn’t have a LIMS in place to address pending updates to DSHEA, CSols can guide you to the right solution for your lab. When you choose to add a properly validated LIMS to your lab’s portfolio, you’ll have peace of mind knowing that whatever regulatory changes happen in the future, your lab will be ready to accommodate them.
Do you have questions about what DSHEA will mean for your lab? Comment below to share your thoughts. Alternatively, contact us today to find out how CSols can help your lab prepare.