The
U.S. Food and Drug Administration (FDA) has issued a new draft guidance
document. This guidance clarifies FDA requirements and regulations pertaining
to allowable excess volume in injectable vials and reinforces the importance of
appropriate fill volumes and labeled vial fill sizes for injectable drug and
biological products.
Microbiology, pharmaceuticals, healthcare and contamination control news and discussion site. Edited by Dr. Tim Sandle (established 2010)
Tuesday, 25 August 2015
FDA draft guidance on injectable volume excess
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