FDA Good Manufacturing Practices Initiative Report Slated For October
This article was originally published in The Pink Sheet Daily
Executive Summary
GMP initiative report will include final guidance on process analytical technologies and aseptic processing, as well as draft guidance on the use of quality systems and computerized systems in clinical trials. The release will also contain "white paper" on prioritizing manufacturing sites for inspections.
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The Council on Pharmaceutical Quality will oversee implementation of the initiative, which covers aseptic processing, quality systems, computerized systems in clinical trials, process analytical technologies and combination products.
GMP Oversight To Get FDA-Wide Coordination Under New Cmte.
The Council on Pharmaceutical Quality will oversee implementation of the initiative, which covers aseptic processing, quality systems, computerized systems in clinical trials, process analytical technologies and combination products.
Quality Systems Guidance Uses Manufacturing Consent Decrees As Model
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