Our operational GxP service catalogue encompasses the following key topics and areas:
- Preparation, management and follow-up of internal and external GxP audits and health authority inspections, including FDA pre-approval inspections
- Document management: Creation, review, approval and administration of Standard Operating Procedures (SOPs) and other controlled documentation
- Qualification of facilities and equipment
- Validation of processes
- Development, implementation and optimization of core processes and governance structures for quality assurance and GxP: Change control, deviation handling, CAPA, Risk Management, PQR, supplier qualification and management, materials management, training management, maintenance, calibration, monitoring.
- Development of GxP training materials and execution of classroom trainings
- Implementation of the revised EU GDP regulation*)
*) The revised EU GDP regulation has been formally implemented in Switzerland as of January 1, 2016. The confirmation of its adequate implementation has now become an integral part of Swissmedic’s inspection protocol for pharmaceutical manufacturers and distribution service providers. First results and available feedback have underlined that required changes have not been fully addressed and implemented across the industry, particularly where these relate to additional requirements for the quality management system. We at RQM GxP Consulting are ready to support you with the identification and remediation of any gaps pertinent to the new regulation, and provide you with practical recommendations and industry best practices. Our background as trained former health authority inspectors coupled with broad industry experience quite uniquely equip us with the understanding of the inspectorate’s expectations and approach, as well as the potential to identify best practical approach for your specific situation.