Computer System Validation
Qualification and validation of Equipment and Computer System
What are the perceived problems in our industry ?
- Variable quality of drugs/medicines.
- Poor Manufacturing practices.
- High costs.
- Too many batch failures & product recalls.
- Poor product specifications.
- CQAs not fully understood.
- Means CPPs not fully defined (risk not managed).
- Post-approval manufacturing changes resisted, leading to limited process improvement.
- Slow process. Too cumbersome. –
- Insufficient information from the pharmaceutical development of products.
- Not widespread use of PAT, QbD, Quality Risk Management, etc.
Why Computer System Validation required ?
- Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
- These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems in order to ensure product safety and effectiveness.
- In the United States, for example, the FDA requires pharmaceutical companies to perform CSV for systems that support the production of the following products:
- Pharmaceuticals
- Biologicals
- Medical Devices
- Blood and blood components
- Human cell and tissue products
- Infant Formulas
- Computer system validation is required when configuring a new system or making a change in a validated system (upgrades, patches, extensions, etc.).
EQUIPMENT QUALIFICATION
The design, construction and delivery of manufacturing systems and equipment into a facility requires a systematic approach in order to meet the user requirements and that of the relevant authorities like cGMP, local governing codes, law and regulations.
Equipment Qualification is the action of proving and documenting that equipment and ancillary systems are properly installed, work correctly, and actually lead to the expected results. This is to ensure that all critical aspects or acceptance criteria for its intended use are met. Qualification is part of the validation process, a regulatory compliance requirement.
