Cleaning Validation for the Pharmaceuticals, Biopharmaceuticals, Cosmetic and Neutraceuticals Industries
DOI:
https://doi.org/10.56511/JIPBS.2014.v1.i01.pp27-38Abstract
Cleaning and cleaning validation are two activities that have the largest opportunity to prevent patient risk by assuring that no cross-contamination can occur. Ineffective cleaning can lead to adulterated product, which may be from previous product batches, cleaning agent or other extraneous material introduced into generated by the process. Cleaning validation is becoming more and more important as we deals with potent, complicated drug substances and complex biotechnology products. This article will over all the element of cleaning validation.
Keywords:
Validation, Cleaning Validation, PharmaceuticalsDownloads
References
Rebecca Brewer Dober Group, Midlothian, Illino: Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical,Medical Device, and Diagnostic Industries Validation of Pharmaceutical Processes Third Edition;491-518
Sharma A, Vaghela J.S, Sharma P, Sharma B, Agrawal M, Jagiwala S : cleaning validation in pharmaceutical industry: a comprehensive approach; pharmatutor-art-1755
Parenteral Drug Association. Points to Consider for Cleaning Validation .Technical Report No. 29, 1998.
Robert Fredrick: The Basic Facts of Cleaning Validation. Canada: Pharmainfo.net; 2004. Available from http://www.pharmainfo.net/reviews/basicfacts-cleaning-validation .
Fourman GL, Mullen MV. Determining cleaning validation acceptance limits for Pharmaceutical manufacturing operations. Pharm Tech. 1993; 54-60.
Vitale KM. Cleaning validation acceptance criteria, 15th Annual Pharm Tech conference, East Brunswi New jersey, September 1995.
Brewer R. Regulatory aspects of cleaning validation, ISPE seminar, Rockville, Maryland, March 1996.
D. Narayana Murthy and K. Chitra Fourman GL, Mullen MV. Determining cleaning validation acceptance limits for Pharmaceutical manufacturing operations. Pharm Tech. 1993; 54-60.
Bodavula Samba Siva Rao: Cleaning validation of albendazole tablet 400 mg. Pharma Innovations. 2012; 1(4): 76-94.
Kumar S: A review on concept of cleaning validation in pharmaceutical Industry. International Research Journal of Pharmaceutical Sciences 2012; 3(7): 17-19.
Kumar V S, Sanjeev T: Overview of cleaning validation in pharmaceutical manufacturing unit. International Journal of Advanced Research in Pharmaceutical & Biosciences. 2012; 1(2): 154-164.
D. Narayana Murthy and K. Chitra: a review article on cleaning validation International Journal of Pharmaceutical Sciences and Research , 2013; Vol. 4(9): 3317-3327.
Kaiser HJ, Tirey JF, LeBlanc DA: Measurement of Organic and Inorganic Residues Recovered from Surfaces. J Valn Tech. 1999; 6(1): 424-436.
LeBlanc DA. Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of Finished Drug Products. Pharm Tech. 1998; 22(10): 136-148.
Fourman GL, Mullen MV. Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations. Pharm Tech. 1993; 17: 54-60.
Inampudi P, Lombardo S, Ruezinsky G. An Integrated Approach for Validating Cleaning Procedures in Biopharmaceutical Manufacturing Facilities. Annals of the New York Academy of Sciences. 1996; 782: 363374.
Rowell FJ, Miao ZF, Neeve RN. Pharmaceutical Analysis Nearer the Sampling Point, Use of Simple, Rapid On-Site Immunoassays for Cleaning Validation, Health and Safety, and Environmental Release Applications. J Pharm & Pharmacology. 1998; 50: 47.
Hwang RC. How to establish an effective Maintenance program for cleaning validation. Pharm Tech. 2000; 24(1): 62-72.
McCormick PY, Cullen LF. Cleaning validation In: Berry, I.R., and Nash, R.A. editor. Pharmaceutical Process Validation. 2nd ed. New York: Marcel Dekker; 1993; 319-349.
Lakshmana P: Cleaning validation and its importance in pharmaceutical Industry. Pharma Times 2010; 42(7): 21--25.
James A. Points to consider in the validation of equipment cleaning procedures. J Parental Sci Tech. 1992; 46 (5): 163-168.
Phillips GF. The need for impurity control. Die Pharm Ind 1989; 51(11):1282-1286.
Published
How to Cite
Issue
Section
Copyright (c) 2014 Babita Lodhi, Poonam Padamwar, Arif Patel

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.


Journal of Innovations in Pharmaceutical and Biological Sciences is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Based on a work at