Recent Advances in Quality Control and Quality Assurance: Enhancing Pharmaceutical Product Integrity and Compliance

Year : 2025 | Volume : 16 | Issue : 02 | Page : 54 62
    By

    Rishabh Viswas,

  • Md Zulphakar Ali,

  • Kamalesh Mistry,

  • Md. Aftab Alam,

  • Noorul Huda,

  • Peeyush Jain,

  1. Research Scholar, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  2. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  3. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  4. Lecturer, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  5. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  6. Dean, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India

Abstract

The pharmaceutical industry is undergoing a paradigm shift driven by stringent regulatory expectations and the demand for high-quality, safe, and efficacious drug products. Quality Control (QC) and Quality Assurance (QA) serve as the two foundational pillars that ensure pharmaceutical integrity from raw material acquisition through to product release. Traditional QC and QA practices, while effective, have been challenged by complex formulations, biologics, and personalized medicine, requiring innovative methodologies and technologies. This review explores recent advances in QC and QA that are revolutionizing the pharmaceutical landscape. Cutting-edge developments such as Process Analytical Technology (PAT), Real-Time Release Testing (RTRT), and high-resolution techniques like ultra-performance liquid chromatography (UPLC) and near-infrared (NIR) spectroscopy have enhanced the precision and speed of quality assessment. Moreover, the adoption of Artificial Intelligence (AI) and Machine Learning (ML) in predictive quality analytics enables real-time monitoring, defect prediction, and adaptive process control, reducing human error and enhancing compliance. On the QA front, innovations in Quality by Design (QbD), electronic Quality Management Systems (eQMS), and blockchain-enabled data integrity systems are reinforcing traceability and accountability across manufacturing chains. Incorporating regulatory frameworks such as ICH Q8-Q12 guidelines and global harmonization strategies have significantly improved standardization. Despite these advancements, the industry faces challenges including high implementation costs, digital transition barriers in emerging economies, and the need for skilled personnel. By highlighting these transformative developments, this review underscores the importance of integrating modern tools into QC and QA practices to uphold pharmaceutical product integrity, patient safety, and regulatory compliance. These emerging strategies not only strengthen current systems but also pave the way for future innovations in the quality-centric pharmaceutical ecosystem.

Keywords: Quality Control, Quality Assurance, Pharmaceutical Compliance, Process Analytical Technology, AI in Pharma, Quality by Design, Regulatory Standards

[This article belongs to Research and Reviews: A Journal of Pharmaceutical Science ]

How to cite this article:
Rishabh Viswas, Md Zulphakar Ali, Kamalesh Mistry, Md. Aftab Alam, Noorul Huda, Peeyush Jain. Recent Advances in Quality Control and Quality Assurance: Enhancing Pharmaceutical Product Integrity and Compliance. Research and Reviews: A Journal of Pharmaceutical Science. 2025; 16(02):54-62.
How to cite this URL:
Rishabh Viswas, Md Zulphakar Ali, Kamalesh Mistry, Md. Aftab Alam, Noorul Huda, Peeyush Jain. Recent Advances in Quality Control and Quality Assurance: Enhancing Pharmaceutical Product Integrity and Compliance. Research and Reviews: A Journal of Pharmaceutical Science. 2025; 16(02):54-62. Available from: https://journals.stmjournals.com/rrjops/article=2025/view=215649


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Regular Issue Subscription Review Article
Volume 16
Issue 02
Received 11/04/2025
Accepted 16/04/2025
Published 02/07/2025
Publication Time 82 Days
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