GxP audit: ensuring your manufacturing facility is quality compliant

GxP audit: ensuring your manufacturing facility is quality compliant

With our global footprint as a service provider, we can support your manufacturing facility in being prepared for audits. Audits are usually conducted using the regulations of the local market, where the products will be distributed and commercialized. According to the local regulations, we support our clients by being prepared for these regulations with a mock audit. This can be a preemptive measure to ensure the client is ready for the actual inspection, increasing the likelihood of obtaining certification. Our experts can also manage your documentation, clearing backlogs and implementing changes supporting a successful audit.  

PLG’s GxP audit service portfolio includes:

PLG’s GxP audit service portfolio includes:

  • GMP and GDP (Good Distribution Practices) inspection readiness support
  • Qualification audits
  • Batch testing and batch release services for EU product release
  • Supply chain assessment and management
  • Training on QMS, GMP/GDP, and quality assurance topics

GxP Audits: a PLG End-to-End Solution

GxP Audits: a PLG End-to-End Solution

  • A complete solution on demand: ISO 15378; GCP; GLP; GMP-GDP; GVP
  • An experience team remote or on-sight including Ex-Health Authority Agencies inspectors, who can provide support for audit projects, an extended team of professional auditors in EU, US/Cana, China and India, of dedicated senior Consultants and Consultants to support CAPA monitoring when needed.
  • Deep knowledge of different pharma environments
  • Awareness about inspection trends as well as agencies inspection outcomes

Key figures

50+

conducted audits (GMPs, GDP)

35+

Auditors in-house with over 15 years of experience in the Pharmaceutical Area

Covered EU, US, and Asian geographies for audits.