Good Manufacturing Practice
Supporting your production with world-class solutions
Good Manufacturing Practice
Supporting your production with world-class solutions
Ensuring excellence, securing compliance
Good Manufacturing Practice (GMP) encompasses every aspect of production, from the sourcing of raw materials to the release of finished products, as well as the qualification and surveillance of key suppliers.
G&L provides comprehensive services that ensure compliance with GMP standards at every stage.
Our expertise supports businesses in maintaining the highest quality of products, from supplier audits to facility inspections, and thorough product release processes.
With G&L’s robust Quality Management System (QMS), we help you minimize risks, enhance operational efficiency, and ensure product safety and regulatory compliance.
Elevating your processes with regulatory expertise
Detailed written procedures are crucial for any process impacting product quality.
A robust QMS must be in place to provide documented evidence that these procedures are rigorously followed at every stage of manufacturing.
G&L can support all critical Quality and Compliance functions (change controls, deviations, product complaints, batch release, etc.) while ensuring procedures are consistently adhered to.
Our team supports the development and implementation of cultural awareness to ensure inspection readiness is a top priority through ongoing compliance checks (internal audits, mock inspections, etc.).
Services include:
- Active Pharmaceutical Ingredient (API) audits
- Drug product (DP) audits
- Pre-approval Inspection (PAI) readiness
- Remediation/troubleshooting
- Quality Management System (QMS) development
- Site and/or system gap assessment
- Assistance with and/or hosting of Regulatory Authority Inspections
- Oversight of suppliers
- For cause audits
- Assessment, development and implementation of GMP Quality system
- On-site and/or remote Quality support
- Remediation
- Person in Plant
- Application, amendment and renewal of Drug Establishment support
- License matters
- GMP training
- QP services
- Document control and lifecycle management
Case study
GMP Quality Assurance support
"G&L employed a targeted approach to resolve the client’s GMP challenges."
