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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Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
