In the intricate realm of pharmaceuticals, where precision and safety are paramount, the FDA’s “Quality Considerations for Topical Ophthalmic Drug Products Guidance for Industry” serves as a beacon. Topical ophthalmic drugs play a pivotal role in managing ocular conditions, ranging from infections to glaucoma. Ensuring the quality of these products is not just a regulatory…
On January 31, 2024, the U.S. Food and Drug Administration (FDA) introduced a significant regulatory update through the issuance of the final rule for the Quality Management System Regulation (QMSR). This rule is aims to align the existing United States’ Quality System (QS) Regulation, as outlined in 21 CFR 820, with the internationally recognized ISO…
In a world where technology is advancing at an unprecedented pace, the integration of digital health technologies into the healthcare landscape has become increasingly vital. Recognizing the significance of this convergence, the U.S. Food and Drug Administration (FDA) has taken a significant step forward this month (October 2023) by establishing a new Advisory Committee on…
Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or quality issue occurring or recurring (hereafter referred to as an ‘issue’). A CAPA record must include…
Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance. In the warning letters issued, the FDA references the FDA’s guidance on Data Integrity; “Your quality system does not adequately ensure the accuracy and integrity of…
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