Tag: manufacturing outsourcing

  • What Ensures Safety in Dietary Supplement Manufacturing?

    What Ensures Safety in Dietary Supplement Manufacturing?

    The regulation of dietary supplements plays a vital role in safeguarding consumer health and ensuring the safety and quality of these products. Dietary supplements encompass a wide range of products, including vitamins, minerals, herbs, and other substances. In this article, we will explore the importance of regulatory oversight in the dietary supplement industry and how solutions like SGS Digicomply can support compliance and enhance safety.

    • Regulatory Framework:

    The regulation of dietary supplements varies across countries, but it typically involves a combination of legislation, guidelines, and oversight by regulatory authorities. These regulations aim to ensure that dietary supplements are safe, properly labeled, and manufactured under quality control standards. Regulatory frameworks help protect consumers from potential risks associated with mislabeling, contamination, or misleading claims.

    • The Demand for ‘Absolute Safety’:

    Consumers often demand assurance of “absolute safety,” which of course is unattainable. Safety can only be evaluated in the context of the use of the product, and any conclusion on the safety of dietary supplements must be based on sound and credible scientific evidence. Whether categorized as dietary supplements, natural health products or food supplements, these products are variously regulated across different jurisdictions worldwide. However, mandatory regulatory requirements aside, with the steadily increasing interest in dietary supplements and the plethora of scientific data being generated to support the potential benefits of various supplement ingredients, the underlying common thread that supports the use of these products is safety.

    • Safety and Quality Standards:

    Regulatory agencies set safety and quality standards for dietary supplements, including requirements for good manufacturing practices (GMPs), quality control testing, and product labeling. These standards help ensure that dietary supplements are produced in a consistent and controlled manner, minimizing the risk of contamination, adulteration, or substandard ingredients.

    Considerations in Evaluating Safety:

    Of key importance for evaluating safety is the concept of the dose-response relationship. This relationship allows for a quantitative assessment of safety and is grounded in the simple underlying principle that “the dose makes the poison.” Without question, adverse effects can occur as a consequence of over-exposure to any dietary constituent. As a result, it is crucial to determine the dose that results in an adverse effect. 

    • Labeling and Claims:

    Regulatory oversight includes requirements for accurate and truthful labeling of dietary supplements. This includes providing clear information about the ingredients, recommended dosage, and any potential allergens. Regulatory agencies also monitor claims made by dietary supplement manufacturers to prevent misleading or unsupported statements that could misinform consumers.

    • Heavy metals, residual solvents, adulterants, contaminants:

    The levels of heavy metals and residual solvents, as well as ingredient-specific contaminants (e.g., pyrrolizidine alkaloids, and aflatoxins), should be controlled in both raw materials and finished products. They should also be evaluated for safety in the target consumer population of that dietary supplement.

    • Adverse Event Reporting:

    Regulatory agencies often establish mechanisms for reporting and monitoring adverse events associated with dietary supplements. This allows for the identification of potential safety concerns and the implementation of appropriate actions to protect public health. Timely reporting and investigation of adverse events contribute to ongoing surveillance and risk assessment within the dietary supplement industry.

    Keep in Mind:

    • Consult your healthcare provider before taking dietary supplements to treat a health condition.
    • Get your healthcare provider’s approval before taking dietary supplements in place of, or in combination with, prescribed medicines.
    • If you are scheduled to have any type of surgical procedure, talk with your healthcare provider about any supplements you take. 
    • Keep in mind the term natural doesn’t always mean safe. Some all-natural botanical products, for example, comfrey and kava, can harm the liver. A dietary supplement’s safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the amount you take. 
    • Before taking any dietary supplement, use the information sources listed in this fact sheet and talk to your healthcare providers to answer these questions:
      • What are its potential benefits for me?
      • Does it have any safety risks?
      • What is the proper dose to take?
      • How, when, and for how long should I take it? 

    References:

  • Major challenges with outsourcing manufacturing for your healthcare brands

    Major challenges with outsourcing manufacturing for your healthcare brands

    Outsourcing manufacturing for healthcare brands can be an appealing solution for many beauty businesses. It allows them to focus on product development, marketing, and scaling, while a third-party manufacturer handles the complexities of production. However, while outsourcing manufacturing sounds like a magic bullet, it comes with its own set of challenges that can impact your brand’s success.

    Why Outsourcing Seems Like the Perfect Solution (But Isn’t Always)

    As a healthcare brand, you’ve probably realized that manufacturing can be time-consuming, capital-intensive, and require specific expertise. The solution? Outsource production. After all, the market is teeming with contract manufacturers ready to turn your formulations into products at scale.

    Here’s what outsourcing promises:

    • Lower upfront investment in equipment and facilities.
    • Access to specialized expertise, allows you to bring innovative products to market faster.
    • Freedom to focus on marketing and customer acquisition rather than worrying about the technicalities of production.

    Sounds like a win, right? But here’s the thing: outsourcing manufacturing is far from a foolproof solution. There are significant challenges that, if left unchecked, could derail your brand’s growth.

    Where Things Start to Go Wrong

    The reality of outsourcing is often different from the glossy promises. Below are key challenges that brands face when they entrust their manufacturing to external companies.

    1. Quality Control Issues

    One of the biggest concerns with outsourcing is quality control. When you’re not handling production in-house, monitoring every aspect of the process is harder. Quality control inconsistencies are an unintended risk when your product goes through multiple hands.

    Manufacturers may cut corners or miss minor defects, which could lead to:

    • Batch inconsistencies.
    • Poor product performance (e.g., separation of ingredients).
    • Failure to meet industry regulations.

    For smaller brands especially, one bad batch could lead to damaged reputations, loss of customers, and costly recalls.

    2. Communication Barriers

    Most healthcare product manufacturers operate on a global scale, with many based in countries far from your headquarters. This opens up potential issues with communication, especially if you’re dealing with a manufacturer in a different time zone or with whom you don’t share the same language.

    Miscommunication over product specifications, timelines, or regulatory standards can lead to delays, incorrect formulations, or packaging mishaps. These missteps are expensive both in time and resources—something to be careful of when working with external partners.

    3. Supply Chain Vulnerabilities

    When you outsource production, you’re not just relying on one company—you’re often relying on a network of suppliers and subcontractors, leading to supply chain instability. Any delay or issue with raw material suppliers can disrupt your entire production schedule.

    This was a harsh reality for many brands during the COVID-19 pandemic, where global supply chains were severely disrupted. Even major players like Estée Lauder experienced production delays due to ingredient shortages and factory shutdowns. For small and mid-sized brands, these disruptions can be devastating.

    4. Hidden Costs

    Outsourcing can be marketed as a cost-saving measure, but hidden costs often arise, especially if scaling quickly. While you may save on equipment and labor, there are often additional expenses related to:

    • Shipping and logistics.
    • Customs and duties (for international manufacturers).
    • Audits and quality assurance inspections.

    Plus, if any batches are faulty, you’re responsible for covering the costs of recalls and returns. This financial strain can eat into your profit margins.

    5. Loss of Control Over Intellectual Property

    When you outsource, you’re trusting another company with your formulations, processes, and product designs. Although most manufacturers sign non-disclosure agreements (NDAs), there’s always the risk of intellectual property theft or misuse, especially in competitive markets like healthcare.

    An example of this was seen in a dispute between L’Oréal and Olaplex, where L’Oréal was accused of stealing patented formulations after working with Olaplex on a potential acquisition deal. While this case escalated to the courts, smaller brands often don’t have the resources to pursue legal action if their IP is misused.

    How to Mitigate Outsourcing Challenges

    Now that we’ve identified the major challenges, let’s discuss actionable solutions that can help your brand navigate outsourcing without compromising on quality or control.

    1. Establish Rigorous Quality Assurance Protocols

    Even though you’re not handling the manufacturing process yourself, you can (and should) implement strict quality assurance protocols. Conduct regular audits of your manufacturer’s facilities, review batch samples, and work with a third-party testing lab if necessary.

    Set clear quality standards with measurable metrics, and ensure your manufacturer holds proper quality control certifications for their processes and ingredients

    2. Maintain Clear and Constant Communication

    Make sure there’s a clear communication strategy in place. This includes:

    • Having a dedicated project manager to liaise with your manufacturer.
    • Using collaboration tools that can document conversations and track production milestones.
    • Regularly visiting your manufacturer’s facility. This not only improves communication but also fosters a stronger working relationship.

    3. Diversify Your Supply Chain

    Don’t rely on a single manufacturer or supplier for your products. Diversifying your supply chain can help mitigate the risk of production delays or ingredient shortages.

    For instance, many brands turned to local manufacturers during the pandemic when international suppliers were struggling. This strategy may involve higher upfront costs, but it will pay off by reducing vulnerability to external disruptions.

    4. Negotiate Transparent Contracts

    Before entering into any agreement, ensure that your contract is clear about:

    • Production timelines.
    • Penalties for late or defective products.
    • Ownership of formulations and intellectual property.

    This level of transparency helps prevent misunderstandings down the road and ensures both parties are on the same page.

    5. Focus on Building a Strong Relationship

    Building trust with your manufacturing partner is crucial for long-term success. Invest time in getting to know them, understanding their processes, and collaborating closely on new products. Manufacturers are more likely to prioritize your brand if they see you as a valuable partner rather than just another client.

    Conclusion: Outsourcing Isn’t Perfect—But It Can Be Managed

    Outsourcing your healthcare brand’s manufacturing comes with real challenges, from quality control issues to communication breakdowns and intellectual property risks. But with the right manufacturer, proper systems, clear communication, and strategic partnerships, you can minimize these risks and grow your brand.

    The key is not to see outsourcing as a set-and-forget solution. It requires constant vigilance, strong relationships, and a proactive approach to quality assurance.