ASEPTIC TECHNIQUES IN PHARMACEUTICAL MANUFACTURING: A COMPREHENSIVE REVIEW OF IMPLEMENTATION CHALLENGES AND REGULATORY EXPECTATIONS

Dr. Nikhil Arun Vyawhare* and Pankaj Pradip Bhaskarwar

Aseptic processing is essential in producing sterile pharmaceutical products. This process is subject to strict rules to ensure patient safety. Keeping sterility during manufacturing is a complex task that requires strong techniques, strict compliance with a documented Pharmaceutical Quality System (PQS), and careful operations. This review paper examines key aseptic practices, points out common challenges in applying them, and explains the expectations set by major global regulatory bodies, including the World Health Organization (WHO), European Medicines Agency (EMA) through EU GMP Annex 1, United States Food and Drug Administration (USFDA), and the Parenteral Drug Association (PDA) Technical Reports. The principles of Quality Risk Management (QRM) play a central role in this framework. They help prevent microbial, particulate, and pyrogen contamination in the final product. This paper also discusses real-world compliance barriers and offers practical insights from regulatory inspections. It provides a clear view on how to connect regulatory theory with manufacturing practice.