Bluciela-Lifesciences SAS, consultancy cGxP Operations & Services
Bluciela-Lifesciences consultancy:
All aspects of GxP Operation & Services
Patient & Criticality Focussed
- FDA Readiness & Recovery Projects - Consent decree and Warning letter avoidance
- Sterility Assurance - Contamination Control, Particulate Reduction, Aseptic Handling
- Construction projects - Design, Validation, Qualification
- Gap analyses - Organisational assessments, Operational Excellence - Reduction in release times
- Data Integrity - Initial assessments, Lifecycle plan, Training, Culture
- Audits - Suppliers, Automation, Logistics (GDP-UCI)
- Regulatory guidance - CMC Filings, Specifications, Product launches, GDP, GMP, GPPV
- Operation Guidance – CMO, CDMO, API, Small Molecules, Biotech, Potent Compounds
- Operational Excellence - Working to keep things simple, effective, with an objective to be :
Right 1st time all the time, every time & on time
With over 40 years of Global Pharma & Logistics experience undertaken under the umbrella of operational excellence.
Management
- Organizational assessments
- Organization strategies - Culture changes
- Efficiency assessments & mapping
- Operational Excellance in Operations, Quality Assurance & Control
Compliance assessments
- Data integrity
- Pre-inspection
- Post inspection
- Filing compliance
Preparation & responses to regulatory audits
- Critical incident management
- Regulatory compliance
- Data Integrity
- Sterility Assurance
- Validation
Process
- Sterility Assurance - Environmental Monitoring, HEPA Filter Management, Contamination Control
- Process Criticality Assessments
- Facility - including utilities, Water Systems
- QA & QC
- Computerised systems
- Data Management
- Process Validation, Equipment Qualification & Cleaning Validation
QMS systems
- Deviations
- OOS
- Change Control
- Complaints
- Stability
- Quality agreements
- Training
- Supplier & Audit Management
Operational Excellence
Operational Excellance in Quality Bluciela-Lifesciences offers support via its consultants and affiliates
- Working to keep things simple, effective, with an objective to be Right 1st time all the time every time on time
