Logo
International Journal of
Management and Economics
ARCHIVES
VOL. 7, ISSUE 2 (2025)
Strategic approaches to capacity planning and management in highly regulated Pharmaceutical manufacturing systems: A comprehensive literature review
Authors
Nitesh Kumar Pandey, Dr. Sameer Kulkarni, Professor Dr. Bhawna Sharma
Abstract

Capacity planning and management in pharmaceutical manufacturing is a critical determinant of operational efficiency, regulatory compliance, and market responsiveness. Highly regulated environments impose stringent constraints on production flexibility, making strategic capacity planning essential for balancing cost, quality, and service levels. This review synthesizes insights from contemporary research on conceptual frameworks and methodologies for capacity planning in pharmaceutical systems. It examines approaches ranging from classical lot-sizing and ramp-up models to integrated supply chain planning, Lean Six Sigma practices, and regulatory-driven strategies. The analysis highlights the interplay between capacity utilization, resource allocation, and compliance requirements, while identifying gaps in existing literature such as limited integration of tactical and strategic planning and insufficient consideration of uncertainty in multi-product environments. By consolidating findings across diverse studies, this paper provides a structured understanding of capacity planning paradigms and offers directions for future research aimed at enhancing resilience and adaptability in pharmaceutical operations.

Download
Pages:135-142
How to cite this article:
Nitesh Kumar Pandey, Dr. Sameer Kulkarni, Professor Dr. Bhawna Sharma "Strategic approaches to capacity planning and management in highly regulated Pharmaceutical manufacturing systems: A comprehensive literature review". International Journal of Management and Economics, Vol 7, Issue 2, 2025, Pages 135-142
Download Author Certificate

Please enter the email address corresponding to this article submission to download your certificate.