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