Cleaning validation process in pharmaceutical industry
A review
Keywords:
process validation, cleaning mechanism, evaluation validation, validation program, regulatoryAbstract
Validation is the skill of designing and practicing the designed steps by the documentation. Process validation also highlights the role of objective measures and statistical tools & analyses and emphasizes knowledge, detection, and control of variability, and gives assurance of the consistency of quality and productivity throughout the life cycle of the product. According to GMP, validation studies are an essential part of the GMP; these are mandatory and done according to the predefined protocols. The process validation is established and gives a high degree of assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristics. The validation study gives the accuracy, sensitive specificity and reproducibility of the test methods employed by the firm which, which shall be accepted and documented , the validation is an essential part of the quality assurance. Validation is one of the necessary steps in achieving and maintaining the quality of the final product. If all the steps of the production process are validated, we can assure that the final product is of the best quality.
Downloads
References
Kaur Harpreet*, Singh Gurpreet, Seth Nimrata. REVIEW ARTICLE PHARMACEUTICAL PROCESS VALIDATION: A REVIEW. Journal of Drug Delivery & Therapeutics; 2013, 3(4), 189-194.
2)Asgharian R, Mehtarpour F, Heydari H A, Step by Step How to Do Cleaning Validation, IJPLS, 2014, 3345-3366.
Lodhi B, Padamwar P, Patel A, Cleaning Validation For The Pharmaceuticals, Biopharmaceuticals, Cosmetic And Nutraceuticals Industries, J. Inno. In Pharma. Bio. Sci. 2014, 1 (1), 27-38.
Babita Lodhi; Cleaning validation for the pharmaceuticals, biopharmaceuticals, cosmetic and nutraceuticals industries; Journal of Innovations in Pharmaceuticals and Biological Sciences; 2014; 1(1); 27 – 38
Patel Payal K, Patel NM and Patel PM. An Overview on Cleaning Validation. Int J Pharm Biol Arch. 2011;2(5):1332-36.
Vinay Jain G. Department of Pharmaceutical Analysis and QA, Mallareddy College of Pharmacy. Cleaning validation. 22 January 2020.
Fauziya Khan, Abdul Sattar Khan and Nutan Rao*. CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRIES. INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY. IJRPC 2020, 10(2), 205-214.
Kathiresan K*, Moorthi C, Prathyusha Y, Grade B. R, Reddy B. K, Manavalan R, ; An overview of pharmaceutical validation; Research Journal of Pharmaceutical, Biological and Chemical Sciences; ISSN: 0975-8585; October – December 2010; RJPBCS 1(4); Page No. 1026.
https://images.app.goo.gl/SK94a45vhpTGubWt6
Ch. Sandhya, Brahmaiah B., Pusuluri D. L. Konkipudi V. S., Process validation: an essential process in the pharmaceutical industry. International Journal of Advances in Scientific Research, 1(4): 179-182,(2015).
Maurya Sadanand, Goyal Devendra and Verma Chandan. Cleaning Validation in Pharmaceutical IndustryAn Overview. PharmaTutor. 2016;4(9):14-20.
Rajpal G, Arya R, Kunwar N. Basic concept of process validation in solid dosage form (tablet): a review. Journal of Drug Delivery and Therapeutics, 2016; 6(4):79-87.doi:10.22270/jddt.v6i4.1282.
Shayne C G, Pharmaceutical Manufacturing Handbook, Regulations and Quality. Cary, North Carolina: Wiley-Inter science, 2018 8(9), 553-554.
https://images.app.goo.gl/WawpVsNhdfV6b3YQ7
https://images.app.goo.gl/qA2tTWf9PaYrsZhR7
https://images.app.goo.gl/zTVTrN7Nr9oruZnT6
Lakshmana Prabu S and Surya Prakash TNK. Cleaning Validation and its importance in Pharmaceutical Industry, Pharma Times. 2010;42(7):20-25.
Agalico J and Frederick Carlton J. A Text Book of Validation of Pharmaceutical Process. 3rd ed. Spring Publisher. 2008;525-65.
https://images.app.goo.gl/5GN9mPVZFGFFENYV9
Heinig K, Vogt C and Werner G. Determination of Linear Alkyl benzene Sulfonates in Industrial and Environmental Sample by CapillaryElectrophoresis. Analyst. 1998;123:349-353
Govind Raj Pal, Arya Rajeshwar Kamal Kant, Joshi Tanuj and Bisht Dheeraj. A review on cleaning validation in the pharmaceutical industry. Journal of drug delivery and therapeutics. 2018;8(3):138-146.
Nassani M. Cleaning Validation In Pharmaceutical Industry. J Vali. 2005;38-58.
Yang P, Burson K, Feder D andMacdonald F. Method Development of Swab Sampling for Cleaning Validation of a Residual Active Pharmaceutical Ingredient. Pharm tech 2009, 86-94.
Kaiser HJ, Tirey JF and LeBlanc DA. Measurement of Organic and Inorganic Residues Recovered from Surfaces. J Van Tech. 1999;6(1):424-36.
LeBlanc DA. Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of Finished Drug Products. Pharm Tech. 1998;22(10):136-148.
Fourman GL and Mullen MV. Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations. PharmTech. 1993;17:54- 60.
Bosdorf V and Krüsymann H. Analysis of detergents and cleaning Agents with Thin-Layer Chromatography. Fourth World Surfactants Congressional Association. Barcelona, Spain. 1996;4:92-95.
Read H. Surfactant Analysis Using HPTLC and the Latroscan. Proceedings of the International Symposium on Instrumental High Performance Thin-Layer Chromatography. 3rd ed. Kaiser R. editor. Institute of Chromatography. Federal Republic of Germany. 1985;157-171.
Henrich LH. Separation and Identification of Surfactants in Commercial Cleaners. J Planar Chrome. 1992;5(2):103-17.
Raghavan R and Mulligan JA. LowLevel (PPB) Determination of Cisplatin in Cleaning Validation (Rinse Water) Samples. I. An Atomic Absorption Spectrophotometric Technique. Drug Device Ind Pharm. 2000;26(4):423-28.
Davidson CA, Griffith CJ, Peters AC and Fielding LM. Evaluation of Two Methods for Evaluating Surface Cleanliness ATP Bioluminescence and Traditional Hygiene Swabbing. Luminescence. 1999;14:33-38.
Inampudi P, Lombardo S and Ruezinsky G. An Integrated Approach for Validating Cleaning Procedures in Biopharmaceutical Manufacturing Facilities. Annals of the New York Academy of Sciences. 1996;782(1):363-374.
Rowell FJ, Miao ZF and 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 and Pharmacology. 1998;50(S9):47
Murthy D. N., Chitra K., Review article on process validation as a quality assurance tool and a theoretical approach. Internationale Pharmaceutica Sciencia, 3(2): 6-14, (2013)
https://images.app.goo.gl/ArwQsUHqBM82hpKJ7
Shruthi N. K., Gupta V.N., Raghunandan H.V., Kashyap UN., USFDA guidelines on process validation - a review. International Journal of PharmTech Research, 6(3): 920-923, (2014).
Published
How to Cite
Issue
Section
Copyright (c) 2022 International journal of health sciences
![Creative Commons License](http://i.creativecommons.org/l/by-nc-nd/4.0/88x31.png)
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Articles published in the International Journal of Health Sciences (IJHS) are available under Creative Commons Attribution Non-Commercial No Derivatives Licence (CC BY-NC-ND 4.0). Authors retain copyright in their work and grant IJHS right of first publication under CC BY-NC-ND 4.0. Users have the right to read, download, copy, distribute, print, search, or link to the full texts of articles in this journal, and to use them for any other lawful purpose.
Articles published in IJHS can be copied, communicated and shared in their published form for non-commercial purposes provided full attribution is given to the author and the journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
This copyright notice applies to articles published in IJHS volumes 4 onwards. Please read about the copyright notices for previous volumes under Journal History.