ABSTRACT:
In pharmaceutical industries there is possibilities of contamination, cross contamination, microbial contamination, adulteration of drug with other active ingredient or contamination with other material like raw material, dust, lubricant, intermediates and air born particle.1 Cleaning validation validate the effectiveness of cleaning procedure for removal of excipient, product residue, degradation product and cleaning agent. Cleaning validation improves the potency and reliability of cleaning in given pharmaceutical production and equipment. The cleaning validation is essential part of the quality assurance. As a result, validating cleaning procedures is critical in the pharmaceutical sector to ensure the safety, efficacy, and quality of drug batches. The purpose of this review is to provide information about cleaning validation in pharmaceutical industry to provide better customer care and quality of product. This article will discuss the relevance of cleaning validation in the pharmaceutical sector, and it will do so in accordance with regulatory guidelines.2,3
Cite this article:
Poonam Khalate, Bharati Chaudhari, Vivekkumar Redasani. Cleaning Validation in Pharmaceutical Industry. Asian Journal of Research in Chemistry. 2022; 15(5):386-0. doi: 10.52711/0974-4150.2022.00068
Cite(Electronic):
Poonam Khalate, Bharati Chaudhari, Vivekkumar Redasani. Cleaning Validation in Pharmaceutical Industry. Asian Journal of Research in Chemistry. 2022; 15(5):386-0. doi: 10.52711/0974-4150.2022.00068 Available on: https://www.ajrconline.org/AbstractView.aspx?PID=2022-15-5-14
REFERENCE:
1. Raj Pal G, Arya RKK, Joshi T, Bisht D. A review on cleaning validation in pharmaceutical industry, Journal of Drug Delivery and Therapeutics, 2018(8); 138-146.
2. Fauziya K, Abdul Sattar K, Nutan R. A review article on cleaning validation in Pharmaceutical industries IJRPC 2020, 10(2), 205- 214.
3. Prasanna Reddy Battu, MS Reddy. RP-HPLC Method for Simultaneous Estimation of Paracetamol and Ibuprofen in Tablets. Asian J. Research Chem. 2(1): Jan.-March, 2009;Page 70-72.
4. Murthy N and Chitra K. A review article on cleaning validation IJPSR, 2013.
5. Singh A, Sharma P. Simultaneous Development and Validation of Analytical Methods for Cleaning Samples Analysis of Gliclazide and Meslamine in Pharmaceutical Industry. Asian J. Research Chem. 2019; 12(6):326-329. doi: 10.5958/0974-4150.2019.00060.9
6. Guide to cleaning validation in API plant. Cleaning validation in Active Pharmaceutical Ingredient manufacturing plant by APIC. 1999;3.
7. Maurya S, Goyal D, Verma C; Cleaning Validation in pharmaceutical industry- An Overview PharmaTutor; 2016;4(9);14-20
8. Modi P.B,.Vairale A.S, Sivaswaroop P. Development and Validation of HPLC method for determination of Ketorolac tromethamine residues on the surface of manufacturing equipment. Asian J. Research Chem. 5(2): February 2012; Page 259-264.
9. Effat S, Nazanin S. R, Farhad A, Arsalan N. A, Maliheh B. T, Massoud A. Validated Stability-Indicating HPLC Method for the Determination of Pantoprazole in the Presence of Its Degradation Products. Asian J. Research Chem. 3(4): Oct. - Dec. 2010; Page 879-884.
10. Robert A Nash and Alfred HW. A Textbook of Pharmaceutical Process Validation. 3rd edition New York: Marcel Dekker. 2003;793-820
11. Koradia SK, Shah PT, Rana RR, Vaghani SS, Pandey S, Jivani NP. Spectrophotometric Determination of Atomoxetine Hydrochloride from Its Pharmaceutical Dosage Forms. Asian J. Research Chem. 2(3): July-Sept., 2009, page 258-259.
12. Mittal A, Parmar S, Gilani S.J, Syed S, Mohamad T. Optimization and Validation for Simultaneous Estimation of Citicoline and Piracetam in bulk and tablet formulations using RP-HPLC method: Analytical quality by design approach. Asian J. Research Chem. 2017; 10(2):198-205. doi: 10.5958/0974-4150.2017.00034.7
13. Agallaco J. Frederick Carelton J: A Text Book of Validation Pharmaceutical Process. Spring Publisher, third edition 2008: 525-565
14. https://www.stockmeier.com/en/products/chemicals/specialty-chemicals/home-industrial-care/non-ionic-surfactants/
15. Patel P. K, Patel NM and Patel PM. An Overview on Cleaning Validation. Int J Pharm Biol Arch. 2011;2(5):1332-36
16. Sayed Imtiaz H, Erfan Sayed A. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries.
17. Modi P.B,.Vairale A.S, Sivaswaroop P. Development and Validation of HPLC method for determination of Ketorolac tromethamine residues on the surface of manufacturing equipment. Asian J. Research Chem. 5(2): February 2012; Page 259-264.
18. Nrusingha P. A Review on Swab sampling and Rinse sampling procedure used in Pharmaceutical industry.
19. Priyanka D.D., Chhabra G. S., Gujarathi N. 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.
20. Pharmaceutical A., Committee I., September R. Active Pharmaceutical Ingredients Committee (APIC) 2016.
21. Jadhav PA, Raut CS, Bidada JP, Buwa BB, Dhabale PN, Dhawale SC. Development and Statistical Validation of UV Spectrophotometric Method for Estimation of Griseofulvin in Tablet Dosage Form. Asian J. Research Chem. 3(2): April- June 2010; Page 404-406.
22. Kamal Hossain, Kamrun Nahar, Ehsanul Hoque Mazumder, Tony Gestier, Tanvir Ahmed Khan, Kaiser Hamid. Development of a Cleaning Validation Protocol for an Odd Case Scenario and Determination of Methoprene residues in a Pharmaceutical Manufacturing Equipment Surfaces by using a Validated UFLC Method. Research J. Pharm. and Tech 2017; 10(11): 3789-3794.
23. Chaudhari BP, Daniel K. A Validated Ultra Performance Liquid Chromatography Method for Simultaneous Estimation of Diacerein and Aceclofenac in Bulk and Pharmaceutical Formulation, Research J. Pharm and Tech 15(4): April 2022. 1467-1471
24. Ashish Singh, Pushpendra Sharma. Simultaneous Development and Validation of Analytical Methods for Cleaning Samples Analysis of Gliclazide and Meslamine in Pharmaceutical Industry. Asian J. Research Chem. 2019; 12(6):326-329.
25. Prakash B. Modi, Ajay S.Vairale, P. Sivaswaroop. Development and Validation of HPLC method for determination of Ketorolac tromethamine residues on the surface of manufacturing equipment. Asian J. Research Chem. 5(2): February 2012; Page 259-264.
26. Kishan Malviya, Monika Maheshwari, Mahendra Singh Rathore. Spectroscopic method for the quantification of residue of Tetramethylthionine chloride on swab from manufacturing equipment in support of cleaning validation. Research Journal of Pharmacy and Technology. 2022; 15(4):1499-4.
27. P.V.S. Machiraju, V.Namratha, Ch. Veerababu. Physicochemical and Biochemical Characterization of Surface Waters in Mangrove areas of Godavari Region for Assessing their Interaction with Ground waters. Asian J. Research Chem. 6(3): March 2013; Page 257-262.
28. Saish Naik, Celina Nazareth, Sanelly Pereira. A Novel HPLC cleaning Validation and Assay method for the simultaneous estimation of Perindopril and Amlodipine. Research J. Pharm. and Tech. 2020; 13(12):5919-5923.
29. Anisha Naik, Celina Nazareth, Sarvada Naik Gaonkar. Cleaning Method Development and Validation for the Simultaneous Estimation of Olmesartan and Atorvastatin by HPLC. Research J. Pharm. and Tech 2020; 13(5):2125-2128.
30. S. Janet Beula, R. Suthakaran, Y. Ramulu, M. Viswaja, G. Venkateswaralu. A Review on Cleaning Validation-Regulatory Guidelines for The Pharmaceutical Industry. Asian Journal of Pharmaceutical Research. 2022; 12(2):167-0.
31. Hapse S.A., Bhagat B.V., Wagh V.S. , Kadaskar P.T.. Cleaning Validation of Paracetamol Tablets as a Dosage Formulation. Research J. Pharma. Dosage Forms and Tech. 2011; 3(5): 215-219 .
32. Pravin N. Pandharmise, Naiyer Shahzad, Anil Kamble, Manohar P. Bhagat. Cleaning Validation for Oral Solid Dosage Form and Its Importance in Pharma Industry. Research J. Pharm. and Tech. 4(9): Sept. 2011; Page 1449-1454.
33. Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya. Cleaning Validation Study of Amoxycillin Trihydrate. Research J. Pharm. and Tech. 2(1): Jan.-Mar. 2009; Page147-150.
34. Chaudhari B, Daniel K. A Validated RP- HPLC Method for simultaneous Estimation of Tizanidine and Nimesulide in Bulk and Pharmaceutical Formulation Research J. Pharm and Tech 2020:13(9):4207-42012