review on pharmaceutical validation and its implications

Alka N Choudharya*, Tanya Sehgal

Shri Guru Ram Rai University, Dehradun, Uttarakhand, India

ABSTRACT

Quality is an essential aim of all manufacturing industries and their goods. The present interest in the pharmaceutical sector is in the several viewpoints on attaining such quality and has indeed been maintained by validation. Validation is among the key processes in attaining and preserving the ultimate product quality. Validation of processes stresses components of process design and maintenance of process control throughout marketing. The validation research must demonstrate and record the precision, sensitivity, characteristics and repeatability of the test techniques used by companies. Validation is therefore a crucial component of quality assurance. This study is intended to offer an understanding of the process validation of pharmaceutical products having a particular focus to the US Food and Drug Administration standards (FDA).

Keywords:

Quality, Validation, Accuracy, Sensitivity, Repeatability, FDA