Quality System Audits

  • Overview
  • Benefits
  • Why Work With NSF?

Our team of experienced former regulators and industry professionals can perform a thorough, in-depth assessment of your pharmaceutical quality system (PQS) against the latest regulatory requirements and industry best practices. We will identify any weaknesses and areas for improvement, and recommend solutions to address deficiencies. Our detailed audit report can then serve as the basis for a site-wide corrective action plan to remediate deficiencies and create a more robust and sustainable PQS. Our pharmaceutical regulatory consultants have extensive experience in conducting audits and we work with clients to remedy weaknesses in their PQS and create a compliant, practical and sustainable system.

The PQS is the foundation upon which everything else is built. We have a proven track record of assisting companies to establish and maintain best-in-class pharmaceutical quality systems.

Benefits

We specialize in pharmaceutical auditing and performing quality systems audits. Our former regulatory agency staff is skilled in performing these audits and our seasoned industry professionals have many years’ experience designing, implementing and operating robust and compliant quality management systems. Because we audit many quality systems every year, we can advise you on current industry best practice. Our staff even helped to write ICH Q10 Pharmaceutical Quality System. No one is better placed to help you implement a compliant, workable and sustainable QMS to meet your business needs for years to come.

Why Work With NSF?

This case study provides a real-world example of how working with our pharmaceutical regulatory consultants can help your company.

Challenge: A highly diversified pharma company based outside Europe had grown by acquisition and as a consequence had developed a range of pharmaceutical quality systems (PQSs) and inherited a number of others. NSF was asked by top management to review the range and extent of GxP quality systems in place and make recommendations for a single company-wide PQS suitable for its modern business model and meeting all anticipated regulatory requirements.

Solution: NSF created a global PQS designed to manage and monitor an organization where all products were developed, manufactured, tested and distributed using external organizations under contract. The PQS also provided meaningful information to senior management to enable them to exercise their role of ownership and continual improvement of the PQS. It also helped by establishing a formal system of quality planning to support continual improvement, managed by the senior management team and administered and supported by corporate QA.

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