Volume : 09, Issue : 05, May – 2022
Title:
05.A REVIEW ON IN PROCESS AND FINISHED PRODUCTS QUALITY CONTROL TESTS FOR TABLETS ACCORDING TO PHARMACOPOEIAS
Authors :
Tavva Naga Panindra Kumar, Pagadala Sai Ram, Pushpa Bindu Nannepamu, M. V. Nagabhushanam, G. Ramakrishna, Brahmaiah Bonthagarala, Y. Ratna Sindhu, Santosh Kumar Ch
Abstract :
A pharmaceutical tablet must satisfy certain standards to claim it to be a quality drug. The main criteria for quality of any drug in dosage form are its safety, potency, efficacy, stability, patient acceptability and regulatory compliance. The quality of a pharmaceutical tablet needs to be designed from the product development stage. At the product design and formulation stage the physical, chemical and biological specifications, to which the product must comply with to fulfill quality requirements, have to determine and the target for quality must be set. In-process quality control (IPQC) tests are strongly related to final product quality because checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specification are the key for good quality pharmaceutical tablets. The purposes of IPQC are to produce a perfect finished product by preventing or eliminating errors at every stage in production. After the manufacturing process is complete finished product quality control (FPQC) tests for pharmaceutical tablets are performed with respect to specification of the pharmacopoeias in order to check that the quality parameters are within acceptance limits or not. The aim of this study is to provide in-process and finished product quality control tests for pharmaceutical tablets according to pharmacopoeias.
Keywords: Pharmaceutical tablets, Pharmacopoeia, In-process quality control (IPQC), Finished product quality control (FPQC), Specifications.
Cite This Article:
Please cite this article in press Tavva Naga Panindra Kumar et al, A Review On In Process And Finished Products Quality Control Tests For Tablets According To Pharmacopoeias., Indo Am. J. P. Sci, 2022; 09(5).,
Number of Downloads : 10
References:
1. SMR Dewan; A Alam; SK Ahamed, Int. Res. J. of Pharm., 2013, 4(1), 96.
2. J Woodcock, Ameri. Pharmace. Rev., 2004, 7(60), 10-15.
3. JM Fortunak1; RD Souza; AA Kulkarni; CL King; T Ellison; LSM Miranda, Antivi. Thera., 2014, 19(3), 4-6.
4. T Mehmood; MR Salaria; GM Herani; MA Qureshi, Ind. J. of Manage. & Soci. Sci., 2009, 3(2), 21-30.
5. L Levi; G walker, Canadi. Medi. Associ., 2010, 91(15), 96.
6. P Tangri; P Mamgain; Shaffi; AML Verma; Lakshmayya, Int. J. of Ind. Pharm. and Bio Sci., 2012, 1(1), 49-51.
7. B Mazumder; S Bhattacharya; A Yadav, Int. J. of PharmTech Res., 2011, 3(1), 366.
8. CH Teja; V Balamuralidhara; S Vinay; RS Bhat; TMP Kumar, Int. J. of Pharm. Tea. & Prac., 2011, 2(4), 65.
9. S Vinay; RS Bhat; V Balamuralidhara; TMP Kumar, Int. J. of Pharm. Tea. & Prac., 2011, 2(4), 176-183.
10. MS Amran. Introduction to Pharmacy, 2nd Edition, Krishnochura Prokashoni, Dhaka, 2015, 20-50.
11. L Lachman, HA Lieberman, JL Kanig. The Theory and Practice of Industrial Pharmacy, 3rd Edition, Lea & Febiger, Philadelphia, 1986, 296-300.
12. LVA Jr. Remington Introduction to Pharmacy, 1st Edition, Pharmaceutical Press, UK, 2013, 146.
13. British Pharmacopoeia Commission. British Pharmacopoeia, 13th Edition, Stationery Office, Great Britain, 2013.
14. G.Sai Hanuja, B.Sai Kumari, M.V.Nagabhushanam, D.Nagarjuna Reddy, Brahmaiah Bonthagarala, Regulatory Requirements for Registration of Generic Drugs in “BRICS” Countries, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 , November-December 2016, 20-40.
15. B.Sai Kumari, G.Sai Hanuja, M.V.Nagabhushanam, D.Nagarjuna Reddy, Brahmaiah Bonthagarala, Current Regulatory Requirements for Registration of Medicines, Compilation and Submission of Dossier in Australian Therapeutic goods Administration, International Journal of Advanced Scientific and Technical Research , ISSN 2249-9954, Issue 6 volume 6, November-December 2016, 144-157.
16. Shaik Salman Basha, S. M. Shakeel, M. V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala, The Assesment of Current Regulatory Guidelines for Biosimilars- A Global Scenario, World Journal of Pharmaceutical Research, ISSN 2277– 7105, volume 6, Issue 1, 351-369.
17. S.M.Shakeel, Shaik Salman Basha, M.V.Nagabhushanam, D.Nagarjuna Reddy, Brahmaiah Bonthagarala, Comparision of Regulataory Requirements for Generic Drugs Dossier Submission in United States and Canada, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 , November-December 2016, 1-19.
18. Society of Japanese Pharmacopoeia. Japanese Pharmacopoeia, 16th Edition, Pharmaceuticals and Medical Devices Agency, Japan, 2011. [19] World Health Organization (WHO). International Pharmacopoeia, 5th Edition, WHO, Switzerland, 2015.