Explain the significance of a Certificate of Analysis (CoA).

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A Certificate of Analysis (CoA) is a vital document in the regulatory landscape for pharmaceuticals, biotechnology, food, and chemical products. The significance of a CoA lies in its function as a verification tool that confirms a product meets the specifications established by the manufacturer. This document typically includes detailed results from testing performed on a batch of product, such as quality and safety analysis, ensuring that it adheres to the required standards and regulations.

The presence of a CoA is critical not only for internal quality control but also for regulatory compliance, as it serves as evidence that the product is manufactured according to the defined quality parameters. This assurance is essential for gaining trust from consumers and regulators alike, and it helps facilitate the safe use of the product in the market.

While price, marketing, and export compliance can be relevant aspects in the context of product distribution and sale, they do not encapsulate the primary purpose of the CoA. Its primary role centers around quality assurance and specification verification, which is fundamentally crucial for maintaining product integrity and consumer safety.

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