Good Manufacturing Practice (GMP) Consulting and Audits

PharmOut consultants can support you to GMP 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. We apply our regulatory knowledge in practical and realistic ways.

We can assist with:

Compliance to MCC, FDA, EU, MHRA, TGA, HSA, NPCB, WHO standards
Practical strategies to raise the level of GMP-compliance
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
Facilitation of regulatory licensing audits and company responses

Quality Assurance Programs

PharmOut can develop practical and effective quality management systems. To ensure the Quality system is fully integrated into everyday life 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