Delivering on the Promise of Purity

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Delivering on the Promise of PurityTM

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Pfanstiehl Quality

Pfanstiehl is globally recognized as a leader in manufacturing cGMP high-purity, low-endotoxin, low-metal injectable-grade excipients and biopharmaceutical components for various applications in bioprocessing, formulation, and specialty areas.

 

All Pfanstiehl’s products are manufactured in the USA at its Waukegan, Illinois facility, which adheres to ICH Q7 standards and is inspected and approved by the US FDA. The facility is conveniently located 35 minutes north of O’Hare airport and the city of Chicago.

Quality Systems:

  • Pfanstiehl, Inc. is registered with the United States Food and Drug Administration (FDA), registration number 1410747.  Pfanstiehl is regularly inspected by the US FDA and other regulatory agencies and remains in good standing.
  • Pfanstiehl’s Quality System is based on International Council for Harmonisation (ICH) Q7. Pfanstiehl applies this quality system to both Active Pharmaceutical Ingredient (API) and Biopharmaceutical Excipient manufacturing.
  • All products made by Pfanstiehl are considered manufactured under Good Manufacturing Practice (cGMP).

Customer Audits:

  • Pfanstiehl hosts 40 – 50 audits annually
  • Customer interaction is a major driver of our quality improvement programs
  • To schedule an onsite audit of Pfanstiehl’s facilities, please contact your business development representative or visit
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Quality Control:

  • Pfanstiehl operates a near full-service Quality Control Laboratory at our facility staffed by highly qualified chemists.
  • Approximately 95% of Certificate of Analysis (CoA) testing is performed onsite.
  • Pfanstiehl continues to evaluate our products and expand our analytical capabilities, including the addition of bioanalytic panel to many of our products

Regulatory Control & Support:

  • DMF Development and Maintenance
  • Management of Audits and Certifications

Quality Assurance

  • Change Control Process
  • Document Control Process
  • Global quality tracking system for deviation and corrective action preventive action (CAPA) management, laboratory investigations, complaints, change control, and supplier management.

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