Excipient cGMP Certification

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

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 demonstrate a high level of GMP compliance against the NSF/IPEC/ANSI 363 GMP standard. This consensus standard was developed with the involvement of excipient manufacturers, excipient customers and the U.S. Food and Drug Administration. NSF/IPEC/ANSI 363 was first issued in 2014 and follows the ISO 9001 framework. Copies can be obtained by emailing USPharma@nsf.org.

NSF certification to the NSF/IPEC/ANSI 363 standard can be accomplished in approximately three months depending on the level of preparedness of the excipient manufacturer. To determine your company’s readiness for certification it is best to complete an internal assessment against the NSF/IPEC/ANSI 363 GMP standard or engage a third party to conduct this assessment. NSF can perform this preliminary assessment; however, this is an activity managed separately from the excipient certification program. Please contact USPharma@nsf.org if you are interested in a preliminary assessment.

To get answers to the most common questions about certification check our FAQ.

Upon GMP certification a Certificate of GMP Conformance is issued to the excipient manufacturer. Audit reports are made available to excipient customers either from the excipient manufacturer directly or NSF can provide authenticated reports with the excipient manufacturer’s authorization.

Services

NSF Health Sciences Certification, LLC offers excipient certification services including cGMP certification for excipient manufacturers and certification audit reports for excipient customer companies.

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. Certification is against the NSF/IPEC/ ANSI 363 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients standard. Achieving NSF certification demonstrates the appropriate level of GMP compliance for pharmaceutical customers globally.

Certification Audit 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. The audit report may be used to evaluate a supplier’s risk profile, to help determine the appropriate audit frequency for a supplier and whether to accept GMP certification in lieu of an on-site audit. Assessing the appropriate level of GMP adherence for pharmaceutical excipients is a requirement in Europe under the Falsified Medicines Act. NSF audit reports provide a comprehensive summary of the GMPs in place at an excipient manufacturer. These reports can be purchased from NSF’s excipient certification program with supplier approval. Contact the program administrator at USPharma@nsf.org if you are interested in the certification audit reports.

Benefits

A decision whether to certify an excipient manufacturer is the responsibility of the NSF Health Sciences Certification, LLC. This decision is taken following a careful review of the manufacturer’s application for certification, the certification audit report and responses to any findings, if applicable. Achieving GMP certification is a significant accomplishment and offers these benefits:

For excipient manufacturers:

  • Fewer site visits and customer audits
  • Very experienced 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 companies:

  • Certification may substitute for an on-site audit of an excipient supplier
  • Certification audits completed by qualified excipient auditors typically take three days
  • Convenient, prompt assessment of excipient manufacturers through available certification audit reports
  • Savings of personnel, time and out-of-pocket expenses

Why Work With NSF?

This case study illustrates 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 ultimately fewer customer audits.

Certification Process

Becoming certified to NSF/IPEC/ANSI 363 involves these five steps:

  1. Application submitted: The client submits an application providing all details required for certification.
  2. ECP audit conducted: We conduct the certification audit against the NSF/IPEC/ANSI 363 standard using ECP qualified auditors.
  3. Report finalized: We summarize the audit results including the prioritization of any audit findings. The excipient manufacturer submits a CAPA report to address audit findings.
  4. Certification body approves: We evaluate the application, audit results and CAPA responses to arrive at a certification decision.
  5. Certificate issued: We issue a certificate of GMP conformance specific to the site and scope of the certification audit. Recertification is required every two years and annual surveillance audits are conducted as needed.

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  • Open What is the advantage of GMP certification through NSF’s excipient certification program?

    With our program, you work with a single certification body and team to manage all aspects of your certification. Certification services are a core activity for NSF so you gain the benefit of an ANSI-accredited certification program (ANSI-Accredited Product Certification Body - Accreditation #1180) offered by a global public health organization. Witness audits are conducted annually to ensure that our auditors and ECP management adhere to program policies and procedures. Auditors are carefully selected on the basis of their industry and auditing experience and trained to audit against the NSF/IPEC/ANSI 363 standard.

  • Open What is the audit standard used for certification?

    NSF/IPEC/ANSI 363 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.

  • Open How do I know my site is ready for certification?

    A gap assessment should be conducted internally or by a third party against the NSF/IPEC/ANSI 363 standard. If the gaps are minor and quickly remediated, the site is more than likely ready for GMP certification. The gap assessment should not be managed by the same group responsible for GMP certification as this risks introducing bias into the certification process.

  • Open Will it make a difference if I am already ISO 9001 certified?

    It will help a great deal. Manufacturing sites that are already ISO 9001 certified will be more familiar with the audit process.  In addition, some of the NSF/IPEC/ANSI audit requirements will be covered under ISO 9001.

  • Open What are the certification steps? How many audit days are required?

    Once a site is ready for certification the process will start by obtaining the pre-audit packet from our certification program administrator. This packet includes an application, pre audit questionnaire, and contract.  Once the application is submitted and contract executed the certification audit can be scheduled.

    A typical certification audit for a single excipient will require three audit days by one ECP qualified auditor.  The auditor will complete the audit and submit a detailed audit report clearly documenting audit findings to ECP management.  After technical review of the report, we submit a draft report to the applicant to correct for any inaccuracies or possible proprietary information.  We then issue a final audit report and the applicant has an opportunity to submit responses to the audit findings.  We use the certification audit report, CAPA summary report and original application to finalize a certification decision which is then communicated to the applicant.  A certificate is issued to the certified excipient manufacturer.  The entire process can be completed within one to three months.

  • Open Does the excipient manufacturer have the opportunity to respond to certification audit findings?

    As part of the audit process, the excipient manufacturer is requested to provide a response to certification audit findings. Audit findings are ranked by severity which helps the applicant determine the priority and depth of remedial action required to address findings.

  • Open What if I disagree with an audit finding?

    The earliest opportunity to raise questions or concerns regarding an audit finding is during the audit closing meeting. If the auditee disagrees with an audit finding as documented in the audit report, a dispute can be filed by the auditee in writing to the ECP program management.  This information will be reviewed with the auditor to determine whether the finding and audit report should be amended.

  • Open What if I disagree with the certification decision of the certification body?

    Our program procedures provide recourse to dispute a certification body decision. This is a formal process and would involve an NSF corporate committee with the appropriate program familiarity as well as various stakeholders as needed to evaluate and resolve the situation.

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