Look at this facility. Can you identify all of the potential points of contamination?
Walking the floor during October’s SupplySide West trade show in Las Vegas, we at InstantGMP Inc. heard manufacturers and consumers alike voice concerns over contaminants. Consumers want assurance that ingredients are safe and pure, and responsible supplement manufacturers likewise want to create a quality, contaminant-free product.
What can you as a business do to prevent contaminants? Identifying types of contamination and mapping out steps at each level of production to prevent them is a good place to start, but it’s equally important to remember that quality is an ongoing process that relies on commitment.
Types of Contamination
Contamination is the introduction of chemical, microbiological, or foreign impurities. Contamination can occur during production, sampling, packaging, storage, or transport.
Preventing contamination begins with facility design. Common sources of contamination due to facility issues include a lack of air filtration systems and poorly located vents, ledges, and drains. Following Good Manufacturing Practices (GMPs) for facility design means using building materials that are smooth and easy to clean, having adequate means of controlling environmental factors such as temperature and differential pressure, and considering the sequence of events in the manufacturing process. A facility following GMPs should have separate areas for production and distribution. The use of HEPA filters can prevent dust and other particles from adulterating your products.
Establishing specifications for the product at each step in the production process is also crucial in preventing contamination. Specifications should be written to ensure the identity and purity of the dietary supplement. Tests, methods, acceptance limits, and safety and handling instructions should be documented in your Standard Operating Procedures. When receiving ingredients from suppliers, Certificates of Analysis should be viewed and confirmed. In order to follow GMPs and effectively avoid contaminated goods from reaching the market, each component must be tested. The test, method, and results must be recorded. Any product that does not meet specifications should be labeled as rejected and quarantined.
Testing is vital to preventing contamination, as it provides proof of a material’s authenticity or identity and potency. It is also one of the main requirements when FDA performs an audit. Tests may include appearance, pH, chemical makeup, absence of biological contaminants, and solubility. Organoleptic, chemical, and biological testing procedures should be in place for incoming ingredients, in-process components, finished batches, labels, and packaging. Because contamination also has the chance to occur during testing via sample gathering, SOPs should be clearly written and followed.
Lather, Rinse, and Repeat for Quality
A well-built facility, flawlessly written specifications, and SOPs are just the beginning. In order to consistently create quality supplements, quality culture must be cultivated. This means hiring and training staff committed to create safe, contaminant-free supplements. Specifications and SOPs should be readily available to the staff. Any changes should be communicated quickly and clearly. Specifications and SOPs should be reviewed at regular intervals. Look for patterns in your workflow that lead to rejected products and address the issue by writing CAPAs and updating SOPs.
Contaminated products strongly affect your bottom line, not only by causing mistrust among consumers, but also with costly recalls, public warning letters, and FDA audits. Failing to follow GMPs can result in bad press and even lawsuits or a shutdown of your facility.
This isn’t just about the bottom line, though. The dietary supplement and food/beverage industry is committed to the overall health and well-being of fellow humans. Following GMPs demonstrates that commitment. Create high-quality, contaminant-free products, and consumers will continue to purchase your product and recommend it to friends. The investment in quality and a continuous-improvement mantra is certainly worth the long-term success.
Richard Soltero, PhD, is the president of InstantGMP Inc. (Cary, NC; www.instantgmp.com), the only cloud-based manufacturing execution system with built-in GMP workflows specific to the dietary supplement industry.
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