In recent years, the nutraceutical, nutrition, and functional food industry has drawn attention to its products, which are great sources of vitamins, minerals, fibre, prebiotics, probiotics, symbiotic, postbiotics, proteins, and low glycemic carbs and may offer health benefits beyond basic diet [3]. However, this growth increases the need for product safety, quality, and regulatory compliance. To achieve this goal, the manufacturers should implement the Certificate of Analysis (CoA) as an essential process.
Interesting News, August 12, 2024.
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In recent years, the nutraceutical, nutrition, and functional food industry has drawn attention to its products, which are great sources of vitamins, minerals, fibre, prebiotics, probiotics, symbiotic, postbiotics, proteins, and low glycemic carbs and may offer health benefits beyond basic diet [3]. However, this growth increases the need for product safety, quality, and regulatory compliance. To achieve this goal, the manufacturers should implement the Certificate of Analysis (CoA) as an essential process.
Definition and Significance of a Certificate of Analysis (CoA)
CoA is a document which describes the necessary characteristics, such as appearance, purity, solubility, and water content, as well as the analytical standards, such as name, CAS number, molecular formula, and molecular weight [1]. In the context of the nutraceutical, nutrition, and functional food industry, CoA documents act as an identification document or serve as a basis for product comparison. As it provides information on the nutritional value, storage conditions, and other properties of the product, such as purity [2]. It acts as an essential document that demonstrates the safety, quality, and adherence to regulations of the product and guarantees that manufacturers goods comply with industry regulations and customer expectations.
Overview of the Nutraceutical, Nutrition, and Functional Food Industry
The nutraceutical, nutrition, and functional food industry departure from traditional diets, introducing a new dimension to the concept of nourishment. These industries cover a vast array of products, comprising functional foods, herbal goods, vitamins, and minerals, as well as dietary supplements [1]. These products are designed to provide specific health benefits beyond basic nutrition. Given the complex nature of these products and the potential impact on consumer health, rigorous quality and safety measures are paramount.
An identification test verifies that the ingredient being purchased is indeed the intended one. It serves as a crucial safeguard for manufacturers to prevent both intentional and unintentional adulteration, while also ensuring that the correct ingredients are used in their products. The method for the identification test must align with the specifications outlined. Test results should detail the lot number, reference standard, and an explanation of why that standard is appropriate. Additionally, the test method protocol, including sample preparation, experimental conditions, and detection techniques, should be clearly documented.
A CoA relevant parameter of raw materials including the identity, purity, potency, and other relevant parameters of raw materials. This information is used to confirm the specified standard required for the raw materials. Similarly, CoAs is used to confirm that final products are aligned with quality standard designed for the raw materials.
Botanical ingredients, especially extracts, are often mixed with other components like carriers and excipients. To provide transparency, a composition statement should be available, detailing all subcomponents present in the raw material or confirming that the botanical ingredient makes up 100% of the material. This document is essential for assessing the feasibility of formulating final products and for creating an accurate ingredient list. It may also determine whether additional regulatory documentation is needed. The composition statement should list all subcomponents, including excipients and preservatives, specify the source of any subcomponent if there are regulatory concerns, and provide a quantitative amount or a reasonable range for each. These subcomponents must align with those listed in another key document, the manufacturing flowchart.
A manufacturing flowchart outlines the key steps involved in transforming starting materials into finished raw materials. Understanding the general manufacturing process is crucial as it can help anticipate the chemical composition of the final product, especially with botanically derived complex ingredients, where the process significantly influences the composition. Although some details may be proprietary, a manufacturing flowchart should at least include information on the starting material(s), mixing, extraction methods, solvents used, excipients, drying process, and the final raw material, listed in the order of execution. These flowcharts must be specific to the ingredient, not generic, and should offer detailed insights into critical processing steps such as grinding, extraction, drying, powdering, and packaging. A flowchart lacking such details provides minimal value.
Importance of CoAs in maintaining consistent product quality: The COA used not only for product inspection it serves beyond that. Moreover, it plays an important role in controlling the product consistency by providing comparison data and monitoring the performance of the product. By checking variation in CoA data, manufacturers have the possibilities to detect quality problems accurately and implement required control measures.
Safety Compliance
It is not only manufacturers who need to maintain CoA as per the GMP compliance, its private label distributors must have a clear understanding of the manufacturing processes to determine whether a packaged and labeled product meets its established specifications and to decide on product approval and release for distribution. A common way to meet this requirement is by obtaining certificates of analysis (CoAs) from the manufacturer. However, regulations now impose additional requirements for CoAs. In the past, many companies accepted CoAs without further scrutiny, but the FDA, FSSAI, EU and other regulatory agencies now mandates that companies first qualify the supplier or manufacturer by verifying the reliability of their CoAs. Companies must also document how the supplier or manufacturer was qualified and periodically re-confirm the accuracy of the CoAs provided.
It is observed that a Certificate of Analysis is used as the critical tool for ensuring the security, conformance and efficacy of products in the nutraceutical, nutrition, and functional food industries. This CoA is mainly useful in protecting consumer health and enhancing brand trust. Further, it is useful in many areas such as product characteristics confirmation, identifying the risk and supporting legal compliance. Therefore, from this blog it is confirmed that the companies require CoA program to work in a fast pace.
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