Q&A: Excipient cGMP Certification

  • 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.

  • Open How long is the excipient GMP certification good for?

    GMP certification expires two years from certificate issuance. Therefore, re-certification is required every two years.

  • Open Is a surveillance audit required?

    An annual surveillance audit may be required depending on the number of certification audit findings. If a site is found to be consistently in substantial conformance to the NSF/IPEC/ANSI 363 standard, a surveillance audit may be waived.

  • Open What is the difference between the ECP program and EXCiPACT certification?

    NSF’s excipient certification program:

    • Standard Applied - NSF/IPEC/ANSI 363-2016 GMP for Pharmaceutical Excipients
    • Accreditation - ANSI accredited
    • Auditor Training / Qualification - ECP qualifies auditors on the basis of their industry and auditing experience and provides ECP training on program policies and the 363 standard. An annual ANSI witness audit is conducted to confirm adherence to program policy.
    • Certification Certificates - Available through ECP and from certified manufacturers
    • Certification Audit Reports - Available either from certified suppliers or obtained from the ECP program administrator with supplier approval

    EXCiPACT certification:

    • Standard Applied - EXCiPACT GMP Standard
    • Accreditation - None
    • Auditor Training / Qualification - EXCiPACT certification bodies are carefully selected and auditor competency requirements are confirmed through training, testing and witness audits.
    • Certification Certificates - Available from certified suppliers
    • Certification Audit Reports - Available from certified suppliers
  • Open What evidence can you provide to show that your program is accredited?

    The ECP program has been accredited by ANSI (ANSI-Accredited Product Certification Body - Accreditation #1180).

  • Open Are audit reports made available to excipient customers?

    Audit reports may be obtained by excipient customers from the certified excipient manufacturer directly. In addition, authenticated audit reports may be purchased from NSF. In this case, our program administrator must obtain supplier approval prior to the issuance of an audit report.

  • Open Will NSF report an adverse situation discovered during an audit to regulatory authorities?

    It is the excipient manufacturer’s responsibility to report potentially adverse or harmful situations to the appropriate regulatory agency.

  • Open How is confidentiality maintained?

    A confidentiality agreement is part of the contractual arrangement. In addition, auditors are contractually bound to uphold confidentiality of client companies.