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4. Regulatory Compliance Agencies like the Environmental Protection Agency (EPA) in the United States set specific pH standards for drinking water. Adhering to these regulations is crucial for water providers to avoid legal repercussions and ensure public health.


Despite advancements in technology and processes, API manufacturing faces several challenges. One of the main issues is the need for rigorous compliance with regulatory requirements. Ensuring that facilities meet GMP standards and passing inspections is a constant challenge for manufacturers. Non-compliance can lead to costly delays, product recalls, and reputational damage.


With the increasing scrutiny from regulatory bodies, the emphasis on quality assurance in API manufacturing has never been more crucial. A single contaminated batch can lead to severe public health repercussions and significant financial losses for manufacturers. Thus, robust quality control mechanisms, including rigorous testing and validation protocols, are integral to the manufacturing process.


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