Quality Control in Pharmaceutical Manufacturing: Principles and Practices

摘要

Quality control in pharmaceutical manufacturing is a critical aspect of ensuring the safety, efffcacy, and consistency of medicinal products. This paper explores the fundamental principles and contemporary practices in pharmaceutical quality control, emphasizing the integration of regulatory frameworks and technological advancements. The discussion begins with an overview of Good Manufacturing Practices (GMP) and Quality by Design (QbD), highlighting their roles in establishing robust quality systems. Subsequently, the paper examines key control points, such as process validation and real-time monitoring, which are essential for mitigating risks and maintaining product integrity. By analyzing these elements, this study underscores the importance of a proactive approach to quality management, which not only complies with global standards but also enhances operational efffciency. The ffndings suggest that continuous improvement and adoption of innovative technologies are pivotal for addressing emerging challenges in the pharmaceutical industry. This paper serves as a reference for practitioners and researchers seeking to optimize quality control processes in drug manufacturing.