Within the pharmaceutical industry, inline near infrared (NIR) spectroscopy is one of the most commonly applied process analytical technologies to monitor content uniformity of powder blends (1).
ARLINGTON, Va. – The Product Quality Research Institute (PQRI) forwarded its first recommendation to the Food and Drug Administration (FDA) for review. The recommendation proposes that in-process ...
Additionally, Content Uniformity (CU), which relies heavily on the proper blend uniformity of the final pharmaceutical product, must be verified for product release. During the development process, ...
The authors modified equipment and the manufacturing process to re-establish content uniformity among tablets. Directly compressing a dry blend of pharmaceutical ingredients into tablets has the ...
The Process Analytical Technology (PAT) initiative of the FDA helps pharmaceutical companies to improve the production process and consistently deliver products of better quality. For this purpose, it ...
The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch ...
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