Abstract
Quality assurance (QA) plays a pivotal role in the pharmaceutical manufacturing process to ensure that the final product meets the safety, efficacy, and regulatory standards. QA encompasses a range of practices including process validation, documentation, training, and risk assessment. With rising global regulatory requirements and advancements in Good Manufacturing Practices (GMP), pharmaceutical companies must integrate robust QA systems to avoid product recalls, contamination, and non-compliance issues. This paper explores the essential elements of QA in pharmaceutical manufacturing, focusing on regulatory frameworks, documentation protocols, risk-based approaches, and continuous improvement practices to maintain product integrity and patient safety.
All articles published in the American Journal of Pharmaceutics are open access and licensed under the Creative Commons Attribution 4.0 International License (CC BY 4.0). This license allows users to:
-
Share — copy and redistribute the material in any medium or format
-
Adapt — remix, transform, and build upon the material for any purpose, even commercially
Under the following terms:
-
Attribution — Appropriate credit must be given, a link to the license must be provided, and any changes must be indicated.
-
Authors retain full copyright of their work.
-
The journal does not restrict reuse of content, provided proper citation of the original publication is made.