Masterarbeit

Harmonizing Storage Conditions for Pharmaceuticals: Implication and Challenges in Drug Storage throughout the Life Cycle in Compliance with Stability Guidelines

Ivan Makhnusha (2025)

Summary:

Language: Englisch

The storage of drug products is fraught with challenges arising from diverse regulatory requirements. The stringent application of Good Manufacturing Practice (GMP) standards, alongside other regulations, often complicates operations within mixed storage facilities. This complexity is further exacerbated by a general lack of clarity regarding how to handle deviations from prescribed storage conditions, and the absence of harmonized standards for monitoring environmental conditions.

This thesis evaluates the multifaceted regulatory landscape governing the storage of drug products, drawing attention to the discrepancies and challenges faced by industry stakeholders. A thorough review of existing regulations across different regions is conducted, with a particular focus on the interpretation and application of the ICH Q1A guideline. The thesis explores the implications of these regulatory requirements on the practical aspects of storage, such as infrastructure, energy consumption, and logistics.

Furthermore, this work synthesizes existing strategies for managing storage deviations and proposes a framework for improving the efficiency and effectiveness of storage practices. By examining case studies and audit reports, it identifies best practices that can alleviate the operational burdens imposed by regulatory complexities. The thesis also highlights the vital role of patient education in maintaining drug efficacy through proper storage and suggests enhancements in labeling of drug products.

In conclusion, the thesis advocates for a more flexible regulatory approach that considers real-world practicalities, including regional climatic variations and the typical conditions experienced by products during their lifecycle. Such an approach would enhance compliance, support global distribution, and ensure that healthcare products retain their safety and efficacy from manufacture to end-use. Ultimately, this research aims to bridge the gap between regulatory expectations and operational realities, fostering improved outcomes in the pharmaceutical supply chain.

Pages: 63

Appendixes: 2, Pages: 14