Author(s):
Shubham Thakare, Ganesh Sonawane, Komal Jadhav, Sadnisha Pagar, Pooja Sonawane, Deepak Sonawane, Sunil Mahajan
Email(s):
shubhamthakare944@gmail.com
DOI:
10.52711/0974-4150.2026.00051 
Address:
Shubham Thakare*, Ganesh Sonawane, Komal Jadhav, Sadnisha Pagar, Pooja Sonawane, Deepak Sonawane, Sunil Mahajan
Divine College of Pharmacy, Satana, Dist. Nashik - 423301, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 4,
Year - 2026
ABSTRACT:
Cleaning validation is a pillar of good manufacturing practice (GMP) delivering documented proof that production equipment is cleaned consistently and reliably eradicating chemical residues, microbial threats and the danger of cross-contamination. In this review we pull together worldwide expectations, the toolbox, at hand toxicology rationale and risk-management doctrines that together define contemporary cleaning validation. The piece maps the field’s shift, from old-school fixed thresholds like the 10ppm rule and the 0.001 dose limit toward grounded exposure limits (HBELs) that are derived from permitted daily exposure (PDE) values. It also surveys vetted sampling tactics swab and rinse techniques, alongside the toolbox of HPLC TOC, UV spectroscopy and mass spectrometry used to confirm cleanliness. Across the breadth of APIs, biologics and potent compounds, the way quality risk management (ICH Q9) lifecycle approaches (ICH Q10) and grouping or bracketing strategies are put into practice is being investigated. Simultaneously a host of emerging trends process technology (PAT) automation, digital data integrity and artificial intelligence are being probed for their capacity to enable real-time, cleaning verification. All things considered these strides paint a picture of cleaning validation shedding its static compliance skin in Favor of a science-infused globally synchronized safeguard, for product quality and patient safety.
Cite this article:
Shubham Thakare, Ganesh Sonawane, Komal Jadhav, Sadnisha Pagar, Pooja Sonawane, Deepak Sonawane, Sunil Mahajan. Shubham Thakare, Ganesh Sonawane, Komal Jadhav, Sadnisha Pagar, Pooja Sonawane, Deepak Sonawane, Sunil Mahajan. Asian Journal of Research in Chemistry.2026; 19(4):326-4. doi: 10.52711/0974-4150.2026.00051
Cite(Electronic):
Shubham Thakare, Ganesh Sonawane, Komal Jadhav, Sadnisha Pagar, Pooja Sonawane, Deepak Sonawane, Sunil Mahajan. Shubham Thakare, Ganesh Sonawane, Komal Jadhav, Sadnisha Pagar, Pooja Sonawane, Deepak Sonawane, Sunil Mahajan. Asian Journal of Research in Chemistry.2026; 19(4):326-4. doi: 10.52711/0974-4150.2026.00051 Available on: https://ajrconline.org/AbstractView.aspx?PID=2026-19-4-8
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