Pharma and Biotech Industry Audit Services for GMP, GxP and Supplier Compliance
NSF experts perform audits and mock inspections across the product lifecycle. Read the article to find out more about our 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:
Pharmaceutical quality systems audits
NSF assesses the quality systems that govern pharmaceutical and biotech operations, including GMP compliance, documentation practises, CAPA, deviation management, supplier oversight and inspection readiness. In some markets, these assessments may be referred to as PQS or QMS audits.
Supplier and contractor audits for pharma and biotech supply chains
NSF helps pharma and biotech teams evaluate suppliers, contractors and external manufacturing partners before quality issues become regulatory or operational risks. Our audit experts can support supplier qualification, contractor oversight, requalification audits, quality agreement reviews and follow-up assessments across regulated supply chains.
These audits can help teams understand whether suppliers and contractors are operating in alignment with GMP expectations, internal quality standards and applicable regulatory requirements.
GxP audits across GLP, GCP, GMP, PV and GDP requirements
NSF provides audit and mock-inspection support across key GxP areas, including GLP, GCP, GMP, pharmacovigilance and GDP. Our life sciences audit experts can help assess whether procedures, documentation, training, data integrity controls and operational practises are aligned with applicable regulatory expectations.
Whether the need is site readiness, supplier oversight, documentation review or post-finding follow-up, NSF experts can help identify gaps and support practical next steps for remediation.
NSF supplier and contractor audits can support:
- Supplier qualification and requalification.
- Contractor and CMO oversight.
- Quality agreement review.
- GMP documentation and process review.
- CAPA and deviation follow-up.
- Risk-based supplier management.
Planning an audit or inspection?
See how NSF helps identify GMP, GxP and supplier compliance gaps.
Quality and compliance due diligence for pharma and biotech acquisitions
NSF supports quality and compliance due diligence for pharmaceutical and biotech acquisitions, partnerships and external manufacturing decisions. Our experts can help evaluate quality systems, manufacturing readiness, regulatory history, supplier risks, documentation practises and remediation needs before commercial or operational commitments are made.
This independent assessment can help teams identify hidden compliance risks, understand potential remediation effort and make more informed decisions during acquisition or partnership planning.
How NSF supports audit readiness and remediation
NSF helps pharma and biotech companies prepare for audits, identify compliance gaps and respond effectively when findings require action. Our audit experts can support teams before, during and after audit activity — from mock inspections and independent assessments to remediation planning and follow-up support.
NSF can help with:
- Audit and mock-inspection planning.
- Pharmaceutical quality system assessments.
- Supplier and contractor audits.
- GxP documentation and process review.
- Data integrity and inspection-readiness assessments.
- CAPA, deviation and remediation support.
- Post-inspection response planning.
Outsourcing audits can be acceptable when appropriate controls are in place, including independence, clear responsibilities and safeguards against conflicts of interest. NSF supports independent third-party audits for pharmaceutical and biotech organisations that need objective review of suppliers, contractors, quality systems or inspection readiness.
Preparing for an upcoming audit?
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Continue building your audit readiness with NSF
We have compiled a list of articles and training courses on the issue of auditing to help you and your colleagues.
Pharmaceutical auditor training
Today’s pharmaceutical auditor needs auditing skills, technical skills, and up-to-date knowledge of the latest regulatory requirements. Meet these needs with NSF.
The importance of GMP auditing services
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.
Webinar: Remote and virtual GMP audits
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, many of whom are former regulators, help clients conduct audits all around the world.
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Preparing for a GMP, GxP or supplier audit?
NSF audit experts can help your team assess quality systems, supplier controls, documentation practises and inspection readiness before gaps become bigger compliance risks.