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Cleaning Validation and Its Protocol in Pharmaceutical Industry
Current Issue
Volume 3, 2015
Issue 4 (August)
Pages: 28-32   |   Vol. 3, No. 4, August 2015   |   Follow on         
Paper in PDF Downloads: 32   Since Aug. 28, 2015 Views: 955   Since Aug. 28, 2015
Authors
[1]
Yasir Mehmood, Faculty of Pharmacy, University of Central Punjab, Lahore, Pakistan.
Abstract
Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. Minimizing equipment downtime has the potential to impact the efficiency and economics of pharmaceutical production. The main purpose of cleaning validation is to improve the effectiveness and consistency of cleaning in a given pharmaceutical production equipment or prevent cross contamination and adulteration of drug products with other active ingredients like unintended compounds or microbiological contamination, leads to prevent several serious problems and also useful in related studies like packaging component cleaning validation. 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 Active Pharmaceutical Ingredients (API) product manufacture. The benefits due to cleaning validation are compliance with federal regulations, identification and correction of potential problems, previously unsuspected which could compromise the safety and efficacy of drug products. In this article cleaning, validation and importance are discussed in brief.
Keywords
Validation, Regulation, API, Safety, Cleaning, Compliance
Reference
[1]
Prabu, L. and T. Suriyaprakash, Cleaning validation and its importance in pharmaceutical industry. Pharma times, 2010. 42(7): p. 21-5.
[2]
Trivedi, H. K., N. Kshtri, and M. C. Patel, A Rapid, Validated RP-HPLC Method for the Simultaneous Determination of Cleaning Validation and Cross-Contamination of 12 Beta-Lactam Compounds. Scientia pharmaceutica, 2013. 81(1): p. 151.
[3]
Tangri, P. and P. S. Rawat, Validation: A Critical Parameter for Quality Control of Pharmaceuticals. Journal of Drug Delivery and Therapeutics, 2012. 2(3).
[4]
Moody, D. L. and G. G. Shanks, Improving the quality of data models: empirical validation of a quality management framework. Information systems, 2003. 28(6): p. 619-650.
[5]
Ballermann, M. A., et al., Validation of the Work Observation Method By Activity Timing (WOMBAT) method of conducting time-motion observations in critical care settings: an observational study. BMC medical informatics and decision making, 2011. 11(1): p. 32.
[6]
Riley, C. M. and T. W. Rosanske, Development and validation of analytical methods. Vol. 3. 1996: Elsevier.
[7]
Nelson, D. and L. E. Sommers, Total carbon, organic carbon, and organic matter. Methods of soil analysis. Part 2. Chemical and microbiological properties, 1982 (methodsofsoilan2): p. 539-579.
[8]
Sluiter, A., et al., Determination of total solids in biomass and total dissolved solids in liquid process samples. National Renewable Energy Laboratory, Golden, CO, NREL Technical Report No. NREL/TP-510-42621, 2008.
[9]
Ang, W. S., S. Lee, and M. Elimelech, Chemical and physical aspects of cleaning of organic-fouled reverse osmosis membranes. Journal of membrane science, 2006. 272(1): p. 198-210.
[10]
Greyson, J. and S. N. Stiso, Device and Method for the Determination of the Specific Gravity or Osmolality of a Liquid, 1977, Google Patents.
[11]
Andreozzi, R., et al., Advanced oxidation processes (AOP) for water purification and recovery. Catalysis today, 1999. 53(1): p. 51-59.
[12]
Hem, J. D., Study and interpretation of the chemical characteristics of natural water. Vol. 2254. 1985: Department of the Interior, US Geological Survey.
[13]
Chau, R., et al., Electrical conductivity of water compressed dynamically to pressures of 70–180 GPa (0.7–1.8 Mbar). The Journal of Chemical Physics, 2001. 114(3): p. 1361-1365.
[14]
Parsons, T. R., A Manual of Chemical & Biological Methods for Seawater Analysis2013: Elsevier.
[15]
Horrocks, D., Applications of liquid scintillation counting2012: Elsevier.
[16]
Bauder, T. A., et al., Irrigation water quality criteria2011: Colorado State University Extension Fort Collins, CO.
[17]
Folegatti, M. V., et al., Calibration of cardy-ion meters to measure nutrient concentrations in soil solution an in plant sap. Scientia Agricola, 2005. 62(1): p. 8-11.
[18]
Islam, K., B. Singh, and A. McBratney, Simultaneous estimation of several soil properties by ultra-violet, visible, and near-infrared reflectance spectroscopy. Soil Research, 2003. 41(6): p. 1101-1114.
[19]
Toetschinger, M. J. and M. M. Dawson, Portable wash and rinse system with dilution, 1999, Google Patents.
[20]
Investigators, E., Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. The New England journal of medicine, 1997. 336(24): p. 1689.
[21]
Plaza, S. M., The safety and efficacy of high-dose chromium. Alternative medicine review, 2002. 7(3): p. 218-235.
[22]
Robichaux, T. BACTERICIDES USED IN DRILLING AND C0MPLETI0N 0PERATI0NS. in Environmental aspects of chemical use in well-drilling operations: conference proceedings: May 1975, Houston, Texas. 1975. Office of Toxic Substances, Environmental Protection Agency.
[23]
Nassani, M., Cleaning validation in the pharmaceutical industry. Journal of validation technology, 2005. 11(4): p. 286.
[24]
GEOLA, F. L., et al., Biological Effects of Various Doses of Conjugated Equine Estrogens in Postmenopausal Women*. The Journal of Clinical Endocrinology & Metabolism, 1980. 51(3): p. 620-625.
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