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Review Papers | Pharmaceutical Science | India | Volume 13 Issue 5, May 2024 | Rating: 5.4 / 10
Advancements in Pharmaceutical Quality Assurance: Innovations, Technologies, and Future Perspectives
Warude Chetan P, Patil Harshada R
Abstract: Pharmaceutical quality assurance practices are constantly changing due to new technologies, and trends coming to the market. This paper reviewed the most recent developments in QA. Advanced analytical tools, such as high - resolution mass spectrometry, nuclear magnetic resonance spectroscopy, and next - generation sequencing are powerful tools suitable for drug substance characterization. Quality by Design and Process Analytical Technology systems allow for proactively optimizing the manufacturing process and producing robust, repeatable manufacturing processes resulting in high - quality products. Digital transformation technologies, such as artificial intelligence (AI), machine learning (ML), and the Internet of Things (IoT), revolutionize QA through real - time monitoring and predictive analytics. Challenges such as globalization and counterfeit drug threats are addressed, emphasizing the need for continuous innovation to meet evolving regulatory standards and patient needs. By embracing emerging technologies and prioritizing patient - centric approaches, the pharmaceutical industry is poised to enhance QA practices and deliver safe, effective medications globally.
Keywords: Pharmaceutical quality assurance, Advanced analytical techniques, Quality by Design (QbD), Process Analytical Technology (PAT), Digital transformation, Patient centricity, emerging technologies
Edition: Volume 13 Issue 5, May 2024
Pages: 1452 - 1455