Validation and GMP expertise
The activities of Kaptas are based on GMP (Good Manufacturing Practice) guidelines. Validation ensures that the equipment we manufacture function in accordance with predetermined criteria.
The needs review and requirements are determined together with the customer. At the same time, the validation procedures with which to measure quality during the process are agreed.
Failure mode and effects analysis (FMEA) is determined in the early phase of validation. The risk analysis is updated during the validation process, if needed. The risk analysis changes with the customer until the end of the life cycle of the product.
Validation is, when conducted in compliance with good manufacturing practices (GMP), a sign that each method, process, equipment, material, function or system leads to the required result.
Mere testing of the end result is not enough to guarantee quality. Quality needs to be designed and constructed within the system.
Main phases of validation: DQ, IQ, OQ and CSV
The main phases of validation include:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Computerized System Validation (CSV)
The main phases are divided into numerous protocols/test documents, with which the functioning of the equipment is determined and verified. Documenting/traceability of the performed measures is essential. Test drives of different main phases (PAT, FAT, SAT) are conducted both in the premises of Kaptas and those of the customer.