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.
Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck
May 28th 2025Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.
