Author(s):
Sanket K Maske, Kunal S. Salunkhe, Amol R. Pawar, Vikas V. Patil, Pankaj S. Patil
Email(s):
Email ID Not Available
DOI:
10.52711/0974-4150.2025.00065 
Address:
Sanket K Maske1*, Kunal S. Salunkhe1, Amol R. Pawar1,2*, Vikas V. Patil1, Pankaj S. Patil1
1Department of Quality Assurance, Kisan Vidya Prasarak Sanstha’s, Institute of Pharmaceutical Education, Boradi 425428.
2Research Scholar, Sankalchand Patel University, Visnagar - 384315 (Gujarat - India).
*Corresponding Author
Published In:
Volume - 18,
Issue - 6,
Year - 2025
ABSTRACT:
Quality Risk Management (QRM) has become fundamental in contemporary pharmaceutical production and product development, signifying a transition from reactive to proactive quality assurance methodologies. This paper analyzes the present status of Quality Risk Management (QRM) application in pharmaceutical validation and product development from 2020 to 2025, emphasizing recent regulatory revisions, technical innovations, and industry best practices. The amalgamation of QRM concepts with advanced technologies like artificial intelligence, process analytical technology (PAT), and digital validation tools has markedly improved the pharmaceutical sector's capacity to guarantee uniform product quality while maximizing resource utilization. This thorough research integrates contemporary literature, regulatory advice, and industry trends to offer insights into the changing environment of pharmaceutical Quality Risk Management, highlighting its essential role in assuring patient safety, regulatory compliance, and sustainable manufacturing practices.
Cite this article:
Sanket K Maske, Kunal S. Salunkhe, Amol R. Pawar, Vikas V. Patil, Pankaj S. Patil. Quality Risk Management in Pharmaceutical Validation and Product Development. Asian Journal of Research in Chemistry. 2025; 18(6):434-8. doi: 10.52711/0974-4150.2025.00065
Cite(Electronic):
Sanket K Maske, Kunal S. Salunkhe, Amol R. Pawar, Vikas V. Patil, Pankaj S. Patil. Quality Risk Management in Pharmaceutical Validation and Product Development. Asian Journal of Research in Chemistry. 2025; 18(6):434-8. doi: 10.52711/0974-4150.2025.00065 Available on: https://www.ajrconline.org/AbstractView.aspx?PID=2025-18-6-10
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