Compliance / Third-Party Audits

  • Overview
  • Why Work With NSF?

Global regulatory agencies (including the FDA, EMA, HC, TGA, etc.) require manufacturers to conduct internal audits to verify the suitability of their QMS systems. In addition, many companies have routine third-party audit programs where an independent organization verifies that a company’s systems and processes meet the appropriate standards and regulations. We offer third-party audits to provide companies worldwide with fresh insight into their procedures via an independent unbiased review of areas that need improvement.

Having a third-party auditing program helps to reduce non-conformances, regulatory actions, poor product quality, loss of certification and registration, and product liability risk.

Why Work With NSF?

We provide a wide range of pharma compliance third-party audits, including:

  • Client site pre-inspection audits
  • Client site open-book audits to confirm GMP standards
  • Pre-selection contractor audits on behalf of a client
  • Routine review audits of existing contractors
  • Supplier audits plus API, excipient and packing component audits

To meet your regulatory commitments, you need audit resources. Whether you need additional expertise without increasing headcount or a fresh perspective on your programs, we can provide the resources you need when you need them, short- or long-term.

Our auditors are senior-level former regulators and highly experienced industry experts who understand processes and the operator perspective. Our auditors go through an intensive auditor training program leading to independent certification as pharmaceutical auditors.

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