To operate in a regulated environment, your company needs Quality Systems, manufacturing processes and control procedures which are in line with the latest prerequisites in in order to avoid compliance risks and to successfully pass inspections.
QProgress can help you design your systems in a compliant and effective way. We will guide you in setting up efficient Quality Systems, support training of your personnel and provide advice for and support you with the preparation, conduct and follow-up of audits and inspections.
Contact us to learn how we can help you find your individual solution.
Our GMP services include:
- Development of Standard Operating Procedures (SOPs)
- Planning and installation of Quality Systems
- Integration of Quality Systems after (or in planning of) mergers and acquisitions
- Review and optimization of existing Quality systems
- GAP-analysis
- Investigation support and development of deviation reports
- Planning and conduct of mock-inspections and preparation of inspection reports
- Preparation of corrective action plans
- Preparation for regulatory inspections (FDA, EU)
- Contract manufacturing
- Preparation and review of GMP-agreements
- Compliance checks
- GMP training