Q10 Pharmaceutical Quality Management and GMP Audits and Reviews

The ISO 9001:2000 Standard provides an excellent framework to develop a Quality System fully compliant with the PIC/S requirements.

An audit of your current operations can identify additions and changes required for registration. PharmOut has experienced consultants who can perform such an audit or instruct your employees on how to undertake one.

This will entail:

FDA-style audits to the Code of Federal Regulations and cGMP with documentation of issues found during the audit, specifically targeting critical process control points (HACCP) and GMP weaknesses.
Provide sample templates and techniques for addressing the required changes.
Design comprehensive audit programs for GMP/GLP compliance and manufacturing control.
Establish comprehensive QA and manufacturing improvement programs due to audit findings.
GMP and company-wide compliance upgrades to all relevant standards (HSA, FDA, EU, PIC/S, ISO) .
Practical strategies to greatly improve the companies GMP-compliance
Expert guidance in the preparation for regulatory and pre approval inspections (PAI).
Facilitation of regulatory licensing audits and company responses.

In essence PharmOut will equip the ISO project team members and other staff with the skills and knowledge required to design, install, maintain, audit and improve an ISO 9001, ISO 13485 compliant quality system.