Excipient cGMP Audits

  • Overview
  • Why Work With NSF?

We can provide both auditing of and certification to excipient current Good Manufacturing Practices (cGMPs) according to IPEC-PQG Excipient GMPs. The major value of the certification process is that your company not only receives a certification, but also a detailed audit report, which customers will require to demonstrate compliance with FMD and FDASIA.

For more information about the NSF Pharma Biotech Excipients Program, email excipients@nsf.org or call +1 857.277.0060.

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

If you are already familiar with the subject matter, but want to explore, consider these topics:

  • Standards
  • Industry norms and best practices
  • Designing audit plans
  • Evaluating observations
  • Personal Q&A and tutoring

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