Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further ...

Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such ...

FDA has also sent several Form 483s, the precursor to most Warning Letters, to Indian companies such as one to Ranbaxy in January 2014. The letters stick out because unlike manufacturing ...

Toyobo responded to an FDA form 483 back in March, but the regulator still has concerns. (FDA) () Particle contamination has proved a stumbling block for many drug manufacturers in recent years. Now, ...

The US pharmaceutical industry is entering a new phase of supply chain transformation. Regulatory pressure, geopolitical ...

Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...

The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...

Process validation is essential in medical device sterilization, pharmaceutical manufacturing, and food and beverage production. Temperature, pressure, and humidity monitoring are critical for ...

The pharmaceutical industry is undergoing a seismic transformation, driven by the integration of data science and analytics. As the demand for novel therapies and personalized medicine surges, leaders ...

Glenmark Pharmaceuticals Ltd on Wednesday informed bourses that the United States Food and Drug Administration (USFDA) conducted a Good Manufacturing Practice (GMP) inspection at its manufacturing ...

Intas Pharma's Dehradun facility receives USFDA warning letter. USFDA cites lapses in quality systems and data integrity. New US approvals halted until compliance issues are resolved. Did our AI ...