Author(s): Shelendra Kumar Manglavat, Deepak Kumawat, Raksha Goswami

Email(s): smanglavat3@gmail.com

DOI: 10.5958/2231-5713.2020.00029.X   

Address: Shelendra Kumar Manglavat1, Deepak Kumawat2, Raksha Goswami2
1Modern Institute of Pharmaceutical Sciences, Gram: Alwasa, Behind Rewati Range, Sanwer Road, Indore (MP) 453111.
2Oriental College of Pharmacy and Research, Indore (M.P.) 453555.
*Corresponding Author

Published In:   Volume - 10,      Issue - 3,     Year - 2020


ABSTRACT:
Validation is consequently one element of quality assurance programs related with individual procedure. The validation batch encountered the specification of tablets. Tablets having batch size of maximum no. of tablets was successfully completed and the manufacturing critical process parameters were validated of this transferred product to show that the process was under control. The study embraces the validation of critical steps of manufacturing such as blending, compression, coating and container packing. It shall also establish the suitability of equipment’s and area used for the production. The process of manufacturing was carried as per the permitted batch manufacturing card. The all process validation batches had been manufactured and validated in full compliance with cGMP requirement.


Cite this article:
Shelendra Kumar Manglavat, Deepak Kumawat, Raksha Goswami. Process Validation for Antiviral Famciclovir tablet. Asian J. Pharm. Tech. 2020; 10(3):170-178. doi: 10.5958/2231-5713.2020.00029.X


REFERENCES:
1. Guidance for Industry, “Process Validation: General Principles and Practices", January 2011. 
2. Venkata RT, Kotta KK, Leela M, Rao K and sasaikanth K, "Process validation of Citalopram Hydrobromide Tablets". Inter J. Res. Pharm. Bio. Sci., ISSN: 2229-3701. 2010, 1(2), 109-123.
3. Phviral, "Process Validation: An Essential Process In Pharmaceutical Industry", January 2010, Pharmainfo.net Retrieved on 6th January 2012.
4. Dashora K, Singh D and Saraf S, "Validation - The Essential Quality Assurance Tool for Pharma Industries." 3(6). Pharmainfo.net Retrieved on 6th January 2012.
5. Jatto E and Okhamafe AO, "An Overview of Pharmaceutical Validation and Process Controls in Drug Development." Trop. J. Pharm. Res. 2002, 1(2), 115-122.
6.   Lachman L., Liberman HA. And Kanig JL. The Theory and Practice of Industrial Pharmacy; 3rd Edn; 600 Washington Square, Philadelphia, USA,1990, pp 330-380.

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Asian Journal of Pharmacy and Technology (AJPTech.) is an international, peer-reviewed journal, devoted to pharmaceutical sciences...... Read more >>>

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DOI: 10.5958/2231–5713 


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