Abstract

PROCESS VALIDATION OF PARENTERAL FORMULATION

Sudarshan Kakad*, Kiran Wale, Mahesh Balsane, Dr.K.S.Salunkhe, Dr.S.R Chaudhari

ABSTRACT

To validate the reproducibility and consistency of a process, the full defined process is carried out using validated equipment, under the established procedure usually at least 3 times. The process must successfully and consistently meet all acceptance criteria each time, to be considered a validated process. The objective of study is to systemically conduct the validation study pertaining to manufacturing activities of parenteral preparation & confirm that the product manufacture with the present method consistently meets the predetermined specifications and quality attributes. The validation of the reproducibility & consistency of the process is carried out using validated equipment under established procedure usually at least three times. The process must successfully & consistently meet all acceptance criteria each time, to be considered a validated process. “Worst caseâ€Â conditions are used for the validation to ensure that the process is acceptable in the extreme case. Sometimes worst case conditions for systems can only really be tested over time & hence must be evaluated using a long term monitoring.

Keywords: Validation, Parenteral, process, reproducibility and consistency