GMP Compliance Audits

  • Overview
  • Benefits
  • 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 quality management systems (QMS).

We provide a wide range of internal and external pharma Good Manufacturing Practice (GMP) compliance 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.

For more information about FDA and Health Canada related services in compliance audits, email uspharma@nsf.org or call +1 202.822.1850.

For information on services related to European and other international agencies, email pharmamail@nsf.org or call +44 1751 432 999.

Benefits

Our GMP compliance audits, and the resulting remediation plans, are trusted by pharmaceutical and biotech companies and regulatory agencies all over the world. Our unique blend of former regulatory agency inspectors and industry professionals ensures that you receive a thorough audit with no stone left unturned and sound, pragmatic recommendations for improvements and remediation.

Why Work With NSF?

This case study provides a real-world example of how working with us can help your company.

Challenge: To evaluate GMP compliance against 21 CFR Parts 210 and 211. NSF was selected to complete a series of audits of over-the-counter (OTC) manufacturing sites in the client’s company network in order to meet third-party audit requirements for retail customers.

Solution: NSF developed the audit plans and established a schedule for two-to-three day GMP audits of OTC manufacturing sites. We selected auditors from our pool of qualified OTC auditors. We reported audit findings to each site and reviewed CAPAs reported by the sites. The multiple-year contract has allowed us to streamline the OTC audit program and follow up on prior year audit findings, thus supporting continuous improvement at each manufacturing site.

Third-party audits by experienced auditors help identify possible GMP gaps and provide an assessment of the level of GMP compliance at a manufacturing location. This independent assessment is an important element of gaining retail customer confidence in an OTC manufacturer.

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