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Paper Details

PROCESS VALIDATION OF PARENTERAL FORMULATION

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

Journal Title:World Journal of Pharmaceutical Research
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 case 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.

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