OTC cGMP Audits

  • Overview
  • Benefits
  • Why Work With NSF?

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.

Benefits

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.

Why Work With NSF?

This case study provides a real-world example of how working with us can help your company.

Challenge: With a company’s OTC products on FDA import alert, NSF needed to identify compliance gaps and provide recommendations to meet FDA requirements under 21 CFR 210 and 211.

Solution: NSF evaluated the FDA findings which had resulted in the import alert for the client, a Chinese OTC manufacturer, and developed a three-phase action plan for the company. The objective of the first phase was to establish a baseline and highlight all the company’s GMP deficiencies, in addition to those deficiencies identified by the FDA. An experienced NSF audit team completed phase 1 by following a quality systems inspection approach (QSIT), and categorizing and prioritizing audit findings and recommendations on the basis of risk. Next, our team completed subsequent on-site audits to confirm the closure of audit findings and facility improvements. The final phase consisted of mock inspections to prepare the site to host future FDA re-inspections and maintain a consistently high level of GMP compliance.

The NSF audit and consultancy support addressed all areas of prior weakness cited by the FDA and significantly raised the level of cGMP compliance across the company site.

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