Process Validation of Sevelamer Hydrochloride Film Coated Tablet
DOI:
https://doi.org/10.22270/ijmspr.v8i2.41Keywords:
Z bench value, Sevelamer Hydrochloride, Process validation, cGMPAbstract
All the three batches resulted in granules with desired flow and compaction which is evident from the data of compressed tablets. At compression stage Weight parameters and Speed parameters evaluated and found within Specified limit as well as, The Statistical analysis process performance is high capable, Data is normal and Z bench value also give assurance that process remains in state of control (Process validation state) during manufacturing of Sevelamer Hydrochloride film coated tablets, 800 mg. Coating process proven as validated from the weight build up data of tablets as validation data provided for after 50% coating, 75% coating and 100% coating and found in accordance with process validation protocol. Finished product result was evidence of Weight gain while the inspection activity as this material is in very high hygroscopic in nature. However results found within specified limit.
Keywords: Z bench value, Sevelamer Hydrochloride, Process validation, cGMP.
References
Umed AN, Abhijit VJ, Salunke VR, Magdum CS, "An Overview of Pharmaceutical Process Validation of Solid Dosage Form." Current Pharma Research, 2013; 824-835. https://doi.org/10.33786/JCPR.2013.v03i02.006
Vikas V, Ujjwal N, Senthil Kumar M, Chandrakant , "Process Validation of Tablet: An Overview." Asian Pacific Journal of Health Science, 2014; 1(1):31-38. https://doi.org/10.21276/apjhs.2014.1.1.5
Guideline on General Principles of Process Validation, FDA, DRH/CDER, 1987.
European Commission, Qualification and Validation, Annex 15 to the EU guide to GMP. Brussels, 2001.
USFDA Guidance for industry "Process validation: general principles and practices." 2011.
Committee on specifications for manufacturing practices for pharmaceutical products, WHO technical report series no. 82, Geneva: world health organization, 1992; 14-79.
Manasa SR, Chandramauli R, "Functional Overview of Process Validation of tablet: A critical Review." Journal of pharmaceutical Research; 2017; 16(3):268-277. https://doi.org/10.18579/jpcrkc/2017/16/3/118767
Satinder Kumar, "Pharmaceutical Process Validation: A CGMP Concept", PharmaTutor; 2015.
Mahato TK, Sharma K, Study of medicinal herbs and its antibacterial activity: A review, Journal of Drug Delivery and Therapeutics 2018; 8(5-s):47-54
Chandan S, Rana AC, Rajni B, Nimrata S, "An Overview of Industrial Process Validation of Tablets." Journal of Drug Delivery and Therapeutics; 2013; 3(3):175-183. https://doi.org/10.22270/jddt.v3i3.489
Harpreet K, Gurpreet S, Nimarata S, "Pharmaceutical Process Validation -A Review." Journal of Drug Delivery and Therapeutics; 2013; 3(4):189- 194. https://doi.org/10.22270/jddt.v3i4.547
Sharma PP, Validation In Pharmaceutical Industry, 5th Edn; Vandana Publications, Delhi, 2013. https://doi.org/10.22270/jddt.v3i4.582
Kamlesh D, Deependra S, Swarnlata S, Saraf S, "Validation - Essential Quality Assurance Tool for Pharma Industries." , 2005; 45-47.
Sindhurnag N, Gouthami B, Madhuri L, Lavanya RV, Krishnaveni N and et al, " The Concept of Process Validation in tablet manufacturing : Review," Journal of Pharmacy Research ; 2012;, 5(2):1264-1267
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Copyright (c) 2022 Basant Kumar Yadav , Neetesh Kumar Jain, Apoorva Tiwari, Supriya Shidhaye
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