The FDA has issued new guidelines that exempt Phase I drugs from certain Good Manufacturing Practice regulations. In issuing the exemptions--which go into effect September 15, the agency notes that ...
(MENAFN- Market Press Release) May 12, 2026 7:00 am - Medical cannabis manufacturers face pharmaceutical-level standards, but moving from agriculture to GMP operations is complex. Here's what ...
The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact ...
The case for migrating from a paper-based quality management system to a digital platform is presented. In 2019, the failure to document quality responsibilities and procedures was the top citation in ...
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 ...
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 ...
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 ...
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 ...
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