Overview CSV (Computer System Validation) is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain industry. It is especially crucial in FDA / EU-regulated industries like biotech and pharma, since products from these sectors impact public health and safety. Why Computer System Validation? A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same principles are applied in computer system validation to a computer system or an information technology system. It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed.
The successful design and realization of an FDA-validatable facility does not happen by chance. Early coordination and communication among all parties involved is essential, from process design and scale-up through cGMP layout, FDA pre-construction design review, commissioning, validation, and on-site inspection by regulatory authorities. A complete "Basis of Design" document is necessary to optimize the utilization of scarce resources. Time spent in design optimization in the front-end, well in advance of the "bricks and mortar" stage, will be saved many times over.
Contract manufacturing [Third party manufacturing] Involvement of third parties is not limited to manufacturing and packaging. Product development, specialized processing, such as radiation sterilization, testing, and logistics, are examples of supply chain elements that have increasingly become candidates for third-party outsourcing.
Successful cleaning validation ensures that patients are not put at risk due to cross contamination during production. Cleaning validation is recognized as the most important activity as it has a direct effect on patient safety and drug quality. As it has adverse effects, the global regulatory authorities are keeping a close check on pharmaceutical companies.