
- BioPharm International-05-15-2017
- Volume 2017 eBook
- Issue 1
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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Articles in this issue
over 8 years ago
Customer Relationship Management in Contract Manufacturingover 8 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeover 8 years ago
CMOs Tackle New Challengesover 8 years ago
Gearing Up for Biosimilarsover 8 years ago
Insourcing vs Outsourcing: Choosing the Right Strategyover 8 years ago
Operations and Quality Oversight of CMOsover 8 years ago
Quality Metrics and CMO AgreementNewsletter
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