The QA service provided by Promeridian may be performed in-company by GMP Consultants with experience in national and international projects:
- Product Quality Review (PQRs)
- Standard Operating Procedures (SOPs)
- User Requirement Specifications (URSs)
- Process validation
- Cleaning validation, clean holding times, dirty holding times
- Deviation management with root cause analysis and CAPA management
- Personalized theoretical and practical training
- Internal audits, GAP analysis and implementation of quality systems according to GMP (EU, FDA) / GDP / ISO 13485 (Medical Devices)
- Preparation and support on FDA Pre - Approval Inspections (PAI)
- Data integrity
An essential element of QA services is internal quality auditing, where subject matter experts of Promeridian support the compliance performance of companies by audits, gap analysis of the existing quality system and implementation of corrective and preventive actions. The aim is to successfully pass GMP (EU, FDA) / GDP / ISO 13485 (Medical Devices) inspections.
Quality risk management is another essential aspect of any service provided by Promeridian. Decisions based on risk assessment according to ICH Q9 Guidelines are integrated across the whole product lifecycle.
