The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization ...

so sites must reevaluate their quality and safety credentials and maintain a state of good manufacturing practice (GMP) readiness. Throughout the pandemic, the lack of FDA inspections has created ...

The FDA's Good Manufacturing Practice (GMP) regulations provide a framework of essential requirements for the methods, facilities and controls used in manufacturing, processing and packaging of a drug ...

Achieving FDA CFR 820 audit success requires a “systematic and proactive approach” to compliance: 1. Management commitment and resource allocation are vital for successful GMP implementation ...

In India’s rapidly growing beauty sector, compliance with regulatory standards is not just a legal necessity but also a ...

The brand appears to have received a national dermatology association's seal—but here's what to know about this recalled face ...

On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) ...

财中社1月15日电 诺泰生物（688076）发布公告，近日公司顺利通过了美国食品药品监督管理局（FDA）的cGMP（现行药品生产质量管理规范）飞行检查。此次检查于2024年9月12日至9月20日进行，检查地点为公司位于江苏省连云港市的生产基地。检查结果显示，公司在药品生产质量管理体系方面符合FDA的要求，顺利通过检查。

US FDA GMP and QMS Support: Manufacturers benefit from consultants' guidance on FDA 21 CFR 820 compliance and the new QMSR standards. Their team assists in setting up and auditing quality ...