Authors : Bikash Ranjan Jena, Suryakanta Swain, Debi Prasad Pradhan, Debashish Ghose
DOI : 10.18231/j.ijpca.2020.018
Volume : 7
Issue : 3
Year : 2020
Page No : 113-118
Cleaning validation is a prominent and ideal practice which is employed in industrial aspects to provide
utmost shielding to develop drug products, so that a cleaning practice removes the particulate matters,
chemicals, as well as the contaminant pathogens reside in active ingredients of drug product in a piece
of apparatus, which are produced or being manufactured. The cleaning validation is established as the
pre-eminent process that ensures the efficiency, safety, consistency of pharmaceutical equipment and
manufactured product of assured quality. The utmost cleaning practice during manufacturing of drug
substances affords the appropriate operator safety measures, organized calibration, description and routine
monitoring of equipments, Sampling procedures, acceptance criteria’s and detection limits of analytical
methods. This also lead to systematic data analysis for estimating of probable contagions in product batches
builds up. Abortive cleaning may lead to adulterated product that may be originated from preceding batches,
clean-up agents or other superfluous materials produced during methodology. Hence to avoid the harmful
contamination, sources, safety measures clean-in-practice is highly recommended as per regulatory and
stability point of view. The present review intensifies the current challenges, basic mechanisms and future
implication of cleaning validation in various analytical development firms and research organizations.
Keywords: Validation, Sampling, Clean in Practice, Acceptance limits, Quality by Design.