To comply with regulatory and GMP requirements and/or ISO, Promeridian offers its clients Third Party Quality Audits Services.
Audit Types:
| GLOBAL: | DATA INTEGRITY |
|---|---|
| Compliance with GMP Standard | Data generated and stored on paper |
| Quality system performance evaluation | Electronic data, Restore and Back Up |
| Due Diligence | Data of suppliers and contract manufacturers |
| SPECIFIC: | VALIDATION AND QUALIFICATION |
| By Systems | Validation documentation (VMP, VP, PVP and Protocols, Reports, etc.) |
| Quality system | Results and reports review |
| Material system | Processes ongoing verification |
| System facilities and equipment | ELEMENTS OF THE PHARMACEUTICAL QUALITY SYSTEM |
| Production system | Change control |
| Conditioning and labeling system | Deviations and CAPA Management |
| Laboratory control system | Product quality and process efficiency |
| Distribution system | Indicators and monitoring by Management |
| By Areas | Training and certification of personnel |
| Warehouses, Aseptic Processing area | Risk management |
| Manufacturing | OOS, OOT |
| Packaging | |
| Quality control | |
| Maintenance | |
| By Critical Elements | |
| Process Critical parameters | |
| Critical quality attributes of product |
