Quality Management System (QMS) & GxP Audit Services
Implementing business processes to ensure the quality of your medicinal products
QMS: 3 simple words with a host of quality activities behind them
One of the most daunting tasks in any quality professional’s career is creating, validating, and executing a QMS. To ensure your facility is ready for its manufacturing or distribution services and meets the latest regulatory standards, we support designing and implementing your QMS; for existing systems, we can conduct a QMS assessment to define and implement a roadmap for QMS optimization, while for new systems, we can design, set up, and implement a new QMS – including preparing all documents (quality manuals, policies, SOPs, WI, forms, and records.)
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 QMS and GxP audit service portfolio includes:
- QMS setup and implementation
- QMS assessment and follow-up remediation support
- GMP and GDP (Good Distribution Practices) inspection readiness support
- Qualification audits
- Batch testing and batch release services for EU product release
- Management of remediation plan following health authority inspection
- Supply chain assessment and management
- Training on QMS, GMP/GDP, and quality assurance topics
PLG’s flexibility as an asset for your needs
We can adapt standard QMS to your organization. Whether you are a start-up, CMO, or larger company, our experts benchmark best-in-class practices to implement the optimal solution for your organization.
Key figures
50+
conducted audits (GMPs, GDP)
Covered EU, US, and Asian geographies for audits.
Implementing a robust Quality Management System is the backbone of excellence in any industry. It’s the commitment to continuous improvement, the pursuit of excellence, and the assurance of customer satisfaction through every facet of an organization’s operations.
Diana Vartanyan
Head of Quality & Compliance, ProductLife Group
