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Univar's Excipient Manufacturer Audit Library

Audit Library

Univar's Excipient Manufacturer Audit Library

The challenge.
Regulatory focus on excipient GMP compliance is increasing – the FDA recommends pharmaceutical manufacturers keep excipient audit documentation available. Pharma manufacturers lack the resources necessary to accommodate the many audit requests.

The solution.
Univar's library of comprehensive excipient manufacturer audits of key producers is based on IPEC GMP guidelines. Our long-standing relationships with the world's premier excipient manufacturers allow us to provide you immediate access to audits that include the most commonly used products: stearates, cellulose ethers, polyols, mineral oils, petrolatums, and more.

The process.
The audits feature compliance activities, including laboratory systems, quality assurance, documentation and records, process and analytical validation, and qualification of analytical instruments and manufacturing equipment, and are renewed every three years. View a sample Excipient Manufacturer Audit here.

Univar's third party auditor holds certifications in disciplines and standards such as ISO 9001, ISO 13485, ISO 17025, ICH, FDA Good Manufacturing Practices and Good Laboratory Practices. Our auditor specializes in excipient and bulk active pharmaceuticals.

  • ASQ Certified Pharmaceutical GMP Professional
  • SQA Registered Quality Assurance Professional in
    Good Laboratory Practices RQAP-GLP ASQ
  • Certified HACCP Auditor
  • ASQ Certified Biomedical Auditor
  • ASQ Certified Quality Auditor

To learn more about the Univar Audit Library, read our brief overview, or contact us at +1 855 888 8648 or DeliveringAnswers@univarusa.com.

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