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 ...

The US Food and Drug Administration (FDA) has issued warning letters to two researchers for failing to meet good clinical practice (GCP) requirements and for not complying with their own trial ...

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 ...

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

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 ...

Q: What are the regulations that govern CGMP requirements for investigational combination products? For example, we are developing a pen injector and need to determine what the regulations say for ...

Dublin, March 31, 2023 (GLOBE NEWSWIRE) -- The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course" training has been added to ...