OTC cGMP Audits


We conduct third-party over-the-counter (OTC) drug audits to current Good Manufacturing Practices (cGMPs). These audits can be used by retailers for their private label programs or as part of their overall supplier/vendor qualification and monitoring programs.

For more information about the NSF Pharma Biotech OTC Program, email otc@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