Quality Management

RPN can support your company in the optimisation of your quality system and audit/inspection preparation, through the following services:

• Preparation of SOPs, working documents and ad-hoc quality systems (in line with GMP, GDP, GCP, GVP, ICH Q10, ISO 9001, ISO 13485)
• Review of manufacturing facilities/processes, quality systems and relevant documentation
• Audit/inspections support and preparation
• Preparation of the responses to audit/inspection findings, including corrective/preventive actions (CAPA)
• Audits of contractor facilities for supplier selection or GMP compliance
• Audit/inspection readiness training
• Internal audit
• Quality risk management, preparation of risk management plan