Commissioning and qualification
Your regulatory compliance partner
Customer issues
1.Define
regulatory requirements
2.Design
according to GMP requirements
3.Comply
with pharmaceutical guidelines and rules
Tailor-made commissioning and qualification approach
Pharmaceutical establishment change request
Site master plan
Project quality plan
Critical analysis / gap analysis
Commissioning
Qualification
Validation
Change control
Audit
Commitment to all stages of qualification
- Design qualification (including critical analysis)
- Factory Acceptance Tests (vessels, skids, electrical cabinets, PLC/scada/MES softwares)
- Site Acceptance Tests (Static tests, Dynamics tests)
- Start-up and configuration follow-up
- Installation Qualification
- Operational Qualification
- Process Qualification assistance
- Cleanning Validation assistance
- Establishment of protocols, test sheets, reports, follow-up of the lifting of non-conformities
Knowledge of rules & guidelines
- cGMP / BPF
- Annexe 1
- ISPE Guidelines
- GAMP V5.0
- 21CFR p11
- ASME-BPE
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