Good Manufacturing Practice (GMP) Consulting and Audits

Pharmaceutical Regulatory GMP Compliance and Audits

We can guide you to compliance through integrated GMP and Quality Management Systems (QMS) enhancements.

Why use us? We can help you achieve compliance that won't cost you the earth and that won't be an unmanageable burden.

Compliance to FDA, EU, MHRA, TGA, HSA, NPCB, WHO standards
GMP and company-wide compliance upgrades to all international standards (FDA, EU, PIC/S, ISO)
FDA-style audits to the Code of Federal Regulations and cGMP
Expert guidance in the preparation for regulatory and pre approval inspections (PAI)
Assessment of current levels of GMP-compliance to all international standards
Practical strategies to raise the level of GMP-compliance
Facilitation of regulatory licensing audits and company responses

PharmOut can develop practical and effective quality management systems that integrate compliance and improvement with new technology. We can:

Review internal audit programs, targeting critical process control points (HACCP) and GMP weaknesses
Design comprehensive audit programs for GMP/GLP compliance and manufacturing control
Take a Risk management approach to QA/QC to ensure resources are utilised effectively
Troubleshoot audits
Establish comprehensive QA and manufacturing improvement programs