Pharma and Biotech Industry Audit Services
NSF experts include former regulators who perform audits and mock inspections across the product lifecycle. Our team also audits suppliers and service providers to the pharmaceutical industry.
Our team provides the following audits:
Quality Systems Audits (PQS)
The quality system (QS) ensures that your company operates in a compliant manner. NSF performs on-site audits across the globe, as well as remote audits. We identify gaps in your QS and can provide pragmatic solutions for closing them.
Supplier and Contractor Audits
Our quality risk management approach helps you define which third-party companies or contract manufacturing organisations (CMOs) to audit on-site or assess remotely. In addition, we provide global auditing services for material suppliers, including CMOs manufacturing all pharmaceutical dosage forms, excipients, and active pharmaceutical ingredients (APIs).
Good Laboratory Practise, Good Clinical Practise, Good Manufacturing Practise, Pharmacovigilance, and Good Distribution Practise regulations apply across the supply chain. Our experts perform audits in each of these disciplines to global regulatory standards, including EMA, U.S. FDA, WHO, PIC/S and ANVISA.
Due Diligence for Acquisitions
Use NSF's independent, experienced team of auditors to determine whether your company's future acquisitions are sound or require remediation. Our team's findings help company stakeholders perform due diligence and make critical decisions about the acquisition process.
How Can NSF Help?
Audits by third-party experienced auditors can help pharmaceutical firms to identify possible gaps in GMP compliance. This audit could be of the company’s own facility, perhaps as part of an internal audit programme, or of a supplier to the company.
NSF GMP audits and subsequent remediation plans are trusted by pharmaceutical and biotech companies and regulatory agencies around the world. If you are going to outsource your auditing, here are some things to consider from NSF’s Executive Director
Lynne Byers: “The EMA Quality of Medicines Question and Answers provides detailed guidance on steps to take when outsourcing audits. Specifically, they answer the question, ‘Is an audit performed by a third party acceptable?’ It is acceptable to outsource audits but there must be appropriate controls in place. “Both parties must also ensure that there are no conflicts of interest (e.g., a commercial relationship between the organisation performing the audit and the organisation being audited) or a personal conflict of interest of the auditor, for example, being employed by the auditee within the last three years or having a financial interest in the auditee.”
NSF Pharma and Biotech Auditing Recommended Resources
We have compiled a list of articles and training courses on the issue of auditing to help you and your colleagues.
Today’s pharmaceutical auditor needs auditing skills, technical skills, and up-to-date knowledge of the latest regulatory requirements. Meet these needs with NSF.
Good Manufacturing Practise (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practises. This article describes what is involved in a GMP audit and NSF expert Lynne Byers describes some key factors to consider if you are going to outsource your auditing.
When access to your supplier’s facilities is limited or not permitted, how can you assure yourself of the quality standards in operation to provide continuity of supply of medicinal products?
Meet Our Expert Team
The NSF team of industry experts and ex-regulators conduct audits with clients all around the world. Click here to read more about some of our expert team.