Our services

Quality Management and Auditing

RPN can support your company in the optimisation of the company 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
  • Quality agreements