Excipient cGMP Audits

  • Overview
  • Services
  • Benefits of Certification and Audit Services
  • Why Work With NSF?

IPEA (International Pharmaceutical Excipients Auditing, Inc.,)(an NSF International company) offers the only excipient GMP certification program accredited by the American National Standards Institute (ANSI). IPEA’s third-party audits are based on NSF/ANSI Good Manufacturing Practices (GMPs) for pharmaceutical excipients.

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. The IPEA audit reports can help pharmaceutical manufacturers ensure their excipients are being manufactured to 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.

For more information about NSF Pharma Biotech auditing in the U.S., email ipea@nsf.org or call +1 202-822-1850.

Services

Excipient Services

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

Excipient GMP Certification

Our IPEA excipient certification program is accredited by ANSI. The accreditation of the program signifies conformance to ISO/ IEC Guide 17065, general requirements for the operation of product-certification systems.

Excipient GMP Audits

We offer IPEA manufacturer and distributor GMP audits 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

IPEA 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, IPEA audit reports demonstrate to potential customers that excipient manufacturing facilities meet applicable GMP standards.

Benefits of Certification and Audit Services

Overall:

  • 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
    “Prior to IPEA/NSF certification Grace Davidson hosted eight to 10 customer audits per year for silicon dioxide NF manufacture at its Baltimore facility. Since certification it has hosted one to two audits per year.”
  • 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, 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?

Meeting your auditing needs

We appreciate the enormous breadth of knowledge that is required to conduct pharmaceutical audits. It is a job that requires a range of skills related to organization, report writing, vendor management and timekeeping. The auditor is also expected to know all about each dosage form, the CFRs and EudraLex, from clinical manufacture to distribution.

NSF's pharma audit staff has been in your shoes. We understand. We work with industry experts who have the appropriate range of skills and constantly seek to fit the right person to the job. In addition to providing a vast range of auditing capabilities, NSF can offer in-depth, IRCA-accredited auditor training from the experts on topics including:

  • Steriles
  • Pharmaceutical microbiology (QP4)
  • Formulation and processing (QP3)
  • Quality management systems (QP8)
  • Biotech

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