Volume : 12, Issue : 02, February – 2025
Title:
CURRENT PERSPECTIVES ON CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY
Authors :
P.Lingaeswara Rao*, Ch.V.Suresh , M.Sameera , M.Ashok Kumar, M.Sandhya Rani, Y. Srikrishna vara prasad
Abstract :
Abstract:
Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. Cleaning procedure is the process of assuring that cleaning procedures effectively remove the potentially dangerous substances from equipments. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. It briefly provides an overview on mechanism of contamination, cleaning mechanisms, cleaning agents, procedure of cleaning, and sampling techniques. In pharmaceutical industry there are some possibilities of contamination and cross contamination because of improper cleaning of equipment, apparatus, processing area or the starting material, this can lead to severe hazards, therefore in pharmaceutical industry we can’t afford any contamination as well as cross contamination. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. TheIndustry wants to achieve these main goals with the help of GMP. This review focused on the different types of cleaning process adapted by pharmaceutical industry, how the process of cleaning validation is done. In the cleaning validation different critical parameter, factor, material and critical process are monitored and validated so that the cleaning consistency can be achieved and documented accordingly.
Keywords: Contamination, clean in place, clean out of place, swab sampling
Cite This Article:
Please cite this article in press P.Lingaeswara Rao et al., Current Perspectives On Cleaning Validation In Pharmaceutical Industry., Indo Am. J. P. Sci, 2025; 12 (02).
Number of Downloads : 10
References:
1. Darshan A. Salade, Kishor S. Arote, P. H. Patil, Pankaj S. Patil, Amol R. Pawar. A Review on Pharmaceutical Cleaning Validation. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):197-2.
2. Rajpal G, Arya RKK, Kunwar N. Basic Concept Of Process Validation In Solid Dosage Form (Tablet): A Review. J. Drug Delivery Ther. 2016 ; 6(4):79-87.
3. Ahir KB, Singh KD, Yadav SP, Patel HS, Poyahari CB. Overview of Validation and Basic Concepts of Process Validation. Scholars Academic Journal of Pharmacy 2014;3(2):178–190.
4. Maurya S, Goyal D, Verma C. Cleaning validation in pharmaceutical industry- An overview. Pharmatutor. 2016;4(9):14-20.
5.Asgharian R, Hamedani M, Heydari A. Step by Step How to Do Cleaning Validation. International Journal of Pharmacy and Life Sciences 2014;5(3):3345–3366.
6.Debaje PD, Chhabra GS, Gujarathi N, Jadhav A. Regulatory Aspects of Cleaning and Cleaning Validation in Active Pharmaceutical Ingredients. Asian Journal of Pharmaceutical Research and Development. 2018;6(3):69–74.
7. Chandani Y, Rajat V, Anju G. Aspects of Pharmaceutical Process Validation: A Review. International Journal of pharmacy and Pharmaceutical Research. 2018;14(1):55–66.
8.Sharma S, Khurana G, Gupta R. A Review on Pharmaceutical Validation and Its Implications. International journal of Pharmaceutical and Biological Research. 2013;1(3):100–104.
9. Jindal D, Kaur H, Patil RK, Patil HC. Validation – In pharmaceutical industry: Equipment validation: A brief review. Adesh University Journal of Medical Sciences and Research. 2020;2(2):94–98.
10. Kumar V., Sanjeev T, Sharma PK. Overview of cleaning validation in pharmaceutical manufacturing unit Kumar. International Journal of Advanced Research in Pharmaceutical and Bio Sciences. 2012;2(2):154–164.
11. Lodhi B, Padamwar P, Patel A. Cleaning Validation for the Pharmaceuticals, Biopharmaceuticals, Cosmetic and Neutraceuticals Industries. Journal of Innovations in Pharmaceuticals and Biological Sciences. 2014;1(1):27–38.
12.Raj A. Cleaning Validation in Pharmaceutical Industries. Journal of Atoms and Molecules 2014;4(4):779–783.
13. Narayana Murthy D, Chitra K. A Review Article On Cleaning Validation. International Journal of Pharmaceutical Sciences and Research. 2013; 4(9):3317–3327.
14. Manu C, Gupta V. Review on cleaning validation in pharmaceutical industry. International Journal of PharmTech Research. 2016;9(3):415–421.
15. Khan F, Khan AS, Rao N. Cleaning Validation in Pharmaceutical Industries. International Journal of Research in Pharmacy and Chemistry. 2020;10(2):205–214.