USFDA Guidelines: A review on Pharmaceuticals Formulations
Year: 2025
Type: article
Abstract: Ensuring Quality in Pharmaceutical Manufacturing should follow ISO9001:2015 Standards and guidelines from regulatory bodies like the FDA, EMA, WHO. To ensure product quality, safety and efficacy which require process validation to guarantee the quality of their products. This applies to both finished drugs and active pharmaceutical ingredients (APIs). The Goal of Quality is the primary objective of Quality Control can produce medications that are secure and essential for their intended use. Process validation involves collecting and analyzing data throughout the manufacturing process, from design to production, to confirm that it consistently produces high quality products.
Author: Dr. S. D. Mankar, Kalyani Nikam*, Vaishnavi Palve, Vaishnavi Nirmal, Pallavi Palve, Jagdish Nikam
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6911905552
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