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Quality control (QC) and quality assurance (QA) processes play a pivotal role in API manufacturing. QC involves testing samples from production batches to ensure they meet predefined specifications. This includes assessing physical properties, potency, and purity. QA focuses on ensuring that the entire manufacturing process, from sourcing raw materials to packaging, complies with regulatory standards. Documentation of these processes is vital for traceability and regulatory compliance.


 

Generic APIs refer to active ingredients that are chemically identical to their branded counterparts but are marketed under their chemical name rather than a brand name. After the patent expiration of the original drug, generic APIs become available, offering more affordable treatment options without compromising efficacy. These APIs are essential for enhancing accessibility to vital medications, particularly in developing countries.


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