This article outlines the importance of Process Validation in pharmaceuticals
1. Significance of Process Validation
1.1 Quality assurance
Validation is an integral part of quality assurance as process control is needed to ensure the quality of the product
Consistency in the product quality can’t be ensured without validation and knowledge of process capabilities
If end product testing is done without validation then it assures little quality due to limited sample size, test sensitivity and number of tests which are performed on sample.
1.2 Optimization of process
Optimization is done to make the process useful or effective
Process optimization is important for obtaining efficiency and maintenance of standards in quality which is the result of validation
Optimization of equipment, facility, process and systems help in meeting quality specifications at minimum cost.
1.3 Reduction of costs
Validation helps in reduction of capital expenditures and utility costs
Costs involved in terms of quality like internal & external failure costs, appraisal costs and preventive costs.
Validation reduces the costs linked with sampling, testing and process monitoring.
Validation ensures reduction of quality costs. They keep the costs minimum by involving fewer re tests, reworks, re inspection and fewer rejections.
Fewer complaints of process related failures are observed
1.4 Other advantages
Validation ensures rapid automation, increased throughput and reliable investigations regarding process deviations.
It also eases maintenance, scale up from development work, reliable start- up of new equipment and increased awareness among employees.
Significance of process validation, quality assurance, validation,reduction of costs, optimization of process
