Consulting
Navigating Complexity, Illuminating Solutions: Research Evaluation Experts
REDS consulting services include training sessions and interactive workshops, support for qualification and validation activities, and assistance for regulatory procedures
Qualification and Validation
We are able to provide the following services to support clients in qualification / validation activities
- Elaboration of Q/V concepts for construction projects, e.g. writing of the Q/V master plan, impact assessments with system categorization, tracking tools
- Elaboration of system-related Q/V documents, e.g. system Q/V plans, URS, DQ / IQ / OQ / PQ test plans, traceability matrices
- Assistance during qualification test or validation study execution at site: Test execution, documentation, evaluation and witnessing
Training and Workshops
We offer training sessions and interactive workshops for the following GMP-related topics
- Quality management system in general: Change control, deviations, internal audits, supplier qualification, etc.
- Qualification and validation of systems and facilities, e.g. production equipment, utility systems, clean rooms, computerized systems
- Operation of GMP facilities: Maintenance, calibration, environmental monitoring and cleaning / disinfection / decontamination
- Validation of methods and processes, e.g. analytical method validation, cleaning validation, manufacturing process validation, etc.
WHO Pre-qualification of Vaccines
With the following services, we are able to provide support during the WHO pre-qualification procedure
- Guidance for elaboration of the PSF (product summary file) and PSF review
- Inspection and gap analysis for existing facilities to assure compliance with WHO GMP guidelines: Clean room layouts and construction, material / personnel / product flows, design of the utility systems, etc.
- Training on shipment validation and other topics
- Review of quality control procedures and stability studies
- Preparation of the WHO site audit
