Laboratory Activities
According to the requirements of a mission, CVO-EUROPE always has available consultants trained in a variety of fields: Biochemists, Biologists, Microbiologists, Metrologists,… with a wide range of laboratory experience and expertise.
Our offer
Method Validation
- Reviews and updates of technical analysis validation procedures in comparison with ICHQ2, ICHQ3 and ICHQ6.
- Analysis of existing analytical systems and consideration of the degree of equipment qualification
- Preparation of a validation plan and risk analysis
- Preparation of a validation protocol
- Assistance in performing tests
- Assistance in result analysis and preparation of validation reports
- Assistance in method transfers: Organization, feasibility studies and transposition necessity, preparation of collaborative study protocols, gap analysis, laboratory bias, report preparation.
- Assistance in Determining Method Equivalence
Quality Control
- Review and update of the analytical control procedures (Raw materials, during manufacturing (IPC), intermediary products and finished products) according to the statutory evolutions.
- Review and Update of Material Safety Data Sheets (MSDS)
- Assistance and preparation of stability testing documentation
- Preparation of laboratory procedure guidelines and instructions:people flow, and clothing rules; sample and sample library management; reagent management; preparation and references; equipment, user instructions, administration and maintenance management…
- Assistance in organizational optimization and analysis planning
- Quality Control physiochemical and microbiological testing, Environment and product quality control, on site with client equipment
Out of Specification (OOS) Management
- Review and adjustment to regulations of the management procedure of outside specifications results
- Definition and setup of an incident investigating methodology/laboratory issue tracking
- Assistance in laboratory inquiries
- Analysis and setup of corrective measures
Metrology
- Analysis of internal metrological tracking and subcontracts, setup of preventive and corrective measures
- Assistance and setup of an equipped solution aimed at optimizing planning management and Metrology integration / Laboratory equipment qualification
- Service provider monitoring, report verification
- Metrology testing onsite with client equipment.
Training
- B33 - Quality Assurance and Quality Control in Control Laboratories
- C13 - OOS/CAPA – Master Out Of Specifications and Optimize Corrective Measures
- A131 - Validation of Analysis Methods
- A50 - Validation of Laboratory Systems and Equipment
Auditing
- GxP, ISO 9001 Quality system regulatory compliance auditing
- Supplier Auditing: Laboratory systems, commercial accommodations
- Computerized system auditing
- FDA Mock Inspection and site preparation