Excipient cGMP Certification

  • Overview
  • Services
  • Benefits
  • Why Work With NSF?

NSF Health Sciences Certification LLC (a wholly-owned subsidiary of NSF International) offers the U.S. market the only excipient Good Manufacturing Practice (GMP) certification program accredited by the American National Standards Institute (ANSI). Third-party certification audits are based on our NSF/ANSI certification program.

NSF’s expertise in standards development and certification helps excipient manufacturers globally build credibility and save time and money through consolidated audits and streamlined certification services. We provide GMP audits and audit program reports. NSF’s excipient certification program provides audit reports that can help pharmaceutical manufacturers ensure their excipients are being manufactured to the appropriate GMPs. This demonstrates compliance with both the new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) and Europe’s Falsified Medicines Directive (FMD), which require risk assessments and appropriate GMPs for excipients.

FDA has stated that a suitably qualified third-party auditing program can be an integral component of an effective supplier qualification program.

To obtain information regarding certification requirements, procedures, fees and applications, or to request certificates or audit reports, please email us at uspharma@nsf.org or call +1 202.822.1850.

Services

We provide three major excipient services: cGMP certification, GMP audits and audit program reports.

Excipient GMP Certification

Our excipient certification program is accredited by ANSI (ANSI-Accredited Product Certification Body - Accreditation #1180). The accreditation of the program signifies conformance to ISO/IEC 17065, general requirements for the operation of product-certification systems.

Excipient GMP Audits

We offer manufacturer and distributor GMP audits as part of our excipient certification program through our global pool of excipient industry-focused auditors. Our auditors are trained and experienced in the unique and specific requirements relating to excipient GMPs. Our audits are designed to serve as a component of a pharmaceutical manufacturer’s overall excipient supplier qualification and monitoring program.

Audit Program Reports

Our excipient certification program audit reports afford excipient purchasers the opportunity to verify supplier excipient GMP conformance without the time and expense of an on-site visit to every supplier manufacturing site. The audit report provides the pharmaceutical company a basis for supplier qualification decisions. For the excipient manufacturer, the audit reports demonstrate to potential customers that excipient manufacturing facilities meet applicable GMP standards.

Benefits

  • Certification is granted after approval by an independent certification board of experienced industry executives and quality leaders.
  • Certification and audit program reports are valid for two years.

For excipient makers:

  • Fewer site visits and customer audits
  • Auditors trained in GMPs appropriate to excipients
  • Opportunity to review draft reports for factual accuracy and confidential details
  • Opportunity to provide a corrective action plan that accompanies the report

For pharmaceutical manufacturers:

  • Certification may substitute for an audit in a supplier qualification program.
  • Certification audits completed by two experienced auditors over at least two days followed by independent review of the audit report details and CAPAs
  • Convenient prompt assessment of excipient manufacturers through available audit program reports
  • Savings of man-power, personnel, time and out-of-pocket expenses

Confidentiality:

  • Audit reports do not contain any company or product proprietary information and are treated as confidential documents.
  • Pharmaceutical customers are only disclosed to the audited excipient maker, never to other customers or other excipient manufacturers.

Why Work With NSF?

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

Challenge: Certification of a major chemical manufacturer to NSF/ANSI/IPEC 363: Good Manufacturing Practices for Pharmaceutical Excipients.

Solution: We conducted a three-day certification audit of this large-scale manufacturer and completed a certification audit report that indicated specific deficiencies that required correction. The deficiencies were pursued by the manufacturer, and we confirmed the corrective actions as acceptable prior to granting certification to the NSF/ANSI/IPEC 363 standard. The benefits claimed by the manufacturer include greater personnel risk awareness, resulting in a more proactive approach to product quality and reduced customer site audits.

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