Key Considerations in Outsourced “On-Site” Audits as Part of Supplier Qualification
This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.
A pharmaceutical manufacturer can perform its own audits as part of supplier qualification; or authorize a suitable third-party audit provider to perform the audit on its behalf; or buy an audit report from a commercial provider. The main focus of interest is the final audit report, which in any case, should be written informatively and distinctly, and should enable the reader to gain a comprehensive impression of the audited firm. This article reports some experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.
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FDA Approves Pfizer Combination Regimen for Treating R/R Diffuse Large B-Cell Lymphoma
February 14th 2025The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.
