“Commissioning, Qualification and Validation,” better known by the acronym “CQV,” is an essential activity in the field of Life Sciences. For qualification or validation activities in the context of new projects, expansion, transfer, continuous improvement, or even response to authorities, our teams of specialists support our clients on all validation topics.
Our expertise CQV
Qualification/Validation of equipment
Our laboratory and analytical equipment specialists assist our clients to qualify their laboratory instruments, validate their computerized systems, or deploy any LIMS infrastructure. They can also support the deployment of data integrity requirements, a critical aspect of Quality Control.
Our production equipment specialists are responsible for qualifying your production equipment, defining risk analyses, supplier capitalization tests, and SI/SA interface test definitions.
- Writing specifications (technical specifications, URS, FDS, etc.)
- Writing and participating in risk analyses
- Writing and participating in risk assessments
- Writing and executing FAT/SAT phases
- Writing and executing QI/QO/QP phases
- Writing and executing protocols/test sheets including DI tests
- Writing intermediate and final reports
- Managing NC/CAPA/Change
- Change validation: equivalence studies, comparability studies, biocomparability studies, equivalence approach
- Writing of specifications (URS, etc.)
- Writing and participation in risk analyses
- Writing of protocols
- Writing and execution of test sheets
- Writing of interim and final reports
- Management of NC/CAPA
Our experts also provide guidance in determining critical parameters and their specifications, utilizing the QbD approach through experimental plans to understand the interactions between parameters (CMA, CQA, CPP) and identify operating ranges. They support the definition of contamination risks and the implementation of CCS to comply with applicable regulations.
EFOR’s expertise also encompasses the definition of continuous process monitoring (monitoring/SPC/CPV/OPV/trend).
Automated and information systems validation
We provide independent, efficient, and relevant SI/SA activities for verifying, testing, and validating the deployment of your systems, software, processes, installations, equipment, and utilities, using a methodology that incorporates risk and criticality analyses.
Our services include:
- Writing specifications (URS…)
- Conducting and contributing to risk analysis
- Executing IQ/OQ/PQ/MiQ phases
- Preparing interim and final reports
- Managing NC/CAPA issues.
Validation of analytical methods
- Study of pharmaceutical or biotechnological validation parameters: specificity, selectivity, linearity, accuracy, limit of detection and quantification, repeatability, intermediate precision, robustness, purity.
- Study of verification parameters for medical devices.
- Writing of protocols: test plan, data analysis methodology, justified acceptability criteria.
- Writing of validation reports, including statistical analysis of results.
- Statistical analysis of obtained data and exploitation of results for optimization of analysis methods and definition of acceptance criteria.
- Valuation of validation results: criteria for method/process comparability studies, validation of reagents, operators, monitoring of maintained validated state, troubleshooting, etc.
Our services include:
- Audit/Inspection, evaluation, gap assessment
- Continuous improvement projects
- Remediation plans, mitigation plans, CAPA plans with workload and scheduling
- Validation plans (protocol-execution-report), CSV, implementation of audit trail reviews, access management, and governance.
In production activities, statistical teams collaborate proactively with production teams to enhance and secure processes. Prior to scale-up, they implement Quality by Design approaches from ICH Q8 to understand and optimize processes. Utilizing experimental designs, they acquire a maximum amount of information on process robustness and recommended operating ranges with a minimum number of tests.
During validation, our statisticians provide expertise regarding the number of experiments, methodology to apply, and documented guidance to direct process experts on acceptability criteria. They participate in intra- and inter-lot homogeneity studies and distribution capability assessments.
InfrastructureAs part of a client’s request for the qualification of infrastructure for a medical device, our teams intervened in defining the qualification strategy, drafted all the IQ, OQ, and PQ protocols, and managed the associated project dynamics.
ERPOur Efor team provided expertise to a pharmaceutical industry client in supervising a SAP version change by managing all associated validation activities.
AsepticOur dedicated project team was involved in all qualification and validation activities, from defining the strategy to the production start-up, for a new aseptic manufacturing facility construction project. This included qualification and validation activities for the facility itself, as well as for equipment, automation systems, and utilities de la ligne.
MethodsOur Soladis statistical experts were able to provide support in the analysis of method validation data by verifying the prerequisites, calculating parameters such as precision, linearity, and accuracy, and proposing appropriate methods in case of heterogeneity (outliers, heterogeneous variances, non-normality, etc.).
InspectionOur experts were able to assist a medical device manufacturer in preparing for an FDA inspection. The Efor teams were tasked with redefining the qualification and validation process to comply with regulatory requirements.
The successive regulatory developments in the pharmaceutical and related industries have resulted in an increasing obligation in terms of validation and qualification in the field.
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