The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first ...

Manufacturers of combination products were offered a list on Tuesday of flexible mechanisms that can be used to comply with the US Food and Drug Administration’s (FDA) requirements for good ...

The main market opportunity lies in the need for comprehensive GMP audits in the pharmaceutical industry. By integrating interviews with traditional methods, such audits provide deeper insights into ...

Managers of FDA-regulated firms must be proactive in how they manage their company's compliance with good manufacturing practices regulations. In September 2004, the US Food and Drug Administration ...

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety. Recently adopted regulations in the European Union, United States, and Japan require pharmaceutical ...

In the pharmaceutical industry, cleanrooms are categorized based on the level of airborne particle concentration necessary to meet the cleanliness standards required for the specific manufacturing ...

Dublin, July 17, 2025 (GLOBE NEWSWIRE) -- The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course" training has been added to ...

Establishing a lab in biopharmaceutical fields such as cell and gene therapies can be demanding, requiring swift and efficient setup while meeting rigorous regulatory standards. The FDA's Good ...

The key market opportunities include enhanced GMP implementation for improved efficiency and compliance in the pharmaceutical industry, leveraging technological advancements, and adapting to rigorous ...