.png
)
A Validation Master Plan (VMP) is a vital document for pharmaceutical companies, providing a detailed strategy for validation activities to ensure the consistent production of high-quality pharmaceutical products. This article will discuss the requirements for a VMP according to regulatory…
Dec 22, 2023 US Food and Drugs Administration (USFDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved…
Pharma is a highly regulated industry. Regulatory audits are an integral part of the drug regulations. Any pharmaceutical industry having a global presence undergo numerous audits in a year by various regulatory agencies. This not only affects their productivity but…
Aug, 23 2021 USFDA approved the first fully licensed COVID19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of…
Against the backdrop of globalization, especially in case of pharmaceutical industry, data integrity has become one of the basic expectations that a regulator expects from a manufacturer. USFDA, MHRA, WHO or any other regulatory agency when inspecting an offshore manufacturing…