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  • Pharmaceutical Validation: A Review
  • 1Department of Pharmaceutical Quality Assurance, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.
    2Department of  Pharmacology, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.
     

Abstract

The practice of validating documentation that demonstrates a process will consistently result in a product that meets expectations is known as validation. Validation studies, according to GMP, are an essential component of GMP; they must be carried out in accordance with predetermined protocols. Process, testing, and cleaning are the bare minimum that need to be validated in order to establish control procedures that monitor output and validate manufacturing processes that might be causing variability in drug products. One of the key components in obtaining and preserving the final product's quality is validation. The accuracy, sensitivity, specificity, and repeatability of the test procedures used by the companies are provided by the validation research, which must be established and recorded. The method used in the pharmaceutical business to increase the dosage form's quality and safety is called process validation. According to cGMP, process validation is a crucial component of quality assurance. Together, validation and quality assurance will guarantee the product's complete quality. Process validation is essential to the pharmaceutical manufacturing process because it provides a high level of assurance and proof that the procedure is producing consistent results, meaning the necessary specifications have been met with accuracy. This article aims to provide a general overview and introduction to validation in the pharmaceutical business.

Keywords

Validation, Pharmaceutical Industry, Quality Assurance, GMP.

Reference

  1. Anju G, Pandey P. Process validation of pharmaceutical dosages form: a review. Biomed J Sci Tech Res. 2017;1(5):1467-75.
  2. Ahir KB, Singh KD, Yadav SP, Patel HS, Poyahari CB. Overview of validation and basic concepts of process validation. Scholars Acad J Pharm (SAJP). 2014;3(2):178-90.
  3. Harpreet K, Gurpreet S, Nimrata S. Pharmaceutical Process validation: a review. J Drug Deliv Ther. 2013;3(4):189-94.
  4. Ojha A, Bharkatiya M, Kitawat S. Pharmaceutical process validation of solid dosage forms: a review. World J Pharm Pharm Sci. 2014;3(6):476-84.
  5. Paruchuri R, Trivedi S, Pavuluri G, Prasanthi B, M SK. Process validation of finasteride tablets. Int J Pharm Chem Biol Sci. 2012;2(1):11-28.
  6. Aleem H, Zhao Y, Lord S, McCarthy T, Sharratt P. Pharmaceutical process validation: an overview. Proc Inst Mech Eng E. 2003;217(2):141-51.
  7. Process validation: general principles and practices by FDA January 2011.
  8. Mishra MK, Kumari P. A review on pharmaceutical validation. J Pharm Innov. 2020;8(6):950-8.
  9. Murthy N, KC. Review article on process validation as a quality assurance tool a Theoretical approach. Int Pharm Sci. 2013;3(2):6-14.
  10. Karthick C, Kathiresan K. Pharmaceutical process validation: a review. J Drug Deliv Ther. 2022;12(1-S):164-70. doi: 10.22270/jddt.v12i1-S.5316.
  11. Nash RA. Process Validation of a 17- Year retrospective study of solid dosage forms. Drug Dev Ind Pharm. 1966;22(1):25-34.
  12. Potdar MA. Current good manufacturing practices for pharmaceuticals. Vol. 2. Delhi: PharmaMed Press Publication; December 2007. p. 8.2-3.
  13. Bhaishaikh IM, Chavan AV, Kadam VP, Desai S, Gurav NN. Process validation: an essential process in pharmaceutical industry. World J Pharm Pharm Sci. 2017;6(8):217-34.
  14. Rachna P, Rana AC, Nimrata S, Rajni B. Introduction and general overview of pharmaceutical process validation: a review. Int Res J Pharm. 2012;3(6):60-4.
  15. Nandhakumar L, Dharmamoorthy G, Rameshkumar S. An overview of pharmaceutical validation: quality assurance view point types of validation. Int J Res Pharm Chem. 2011;1(4).
  16. Banji industrial process validation of solid dosage forms–an overview. Int J Pharm Sci Rev Res. 2010;3(2):56-61.
  17. Jatto E, Okhamafe A. An overview of pharmaceutical validation and process controls in drug development. Trop J Pharm Res. December 2002;1(2):115-22. doi: 10.4314/tjpr.v1i2.14592.
  18. Patel VB, Rathwa MR, Patel K. Studies in prospective process validation of cimetidine tablet dosage form. Int J Res Pharm Biomedsci. 2011;2(4):1823-36.
  19. Jindal D, Kaur H, Patil RK, Patil HC. Validation pharmaceutical industry: Equipment validation: A brief review. Adesh Univ J Med Sci Res. 2020;2(2):94-8.
  20. Kakad SB, Kolhe MH, Dukre TP. A review on pharmaceutical validation. Int J Pharm Qual Assur. 2020;11(3):338-42. doi: 10.25258/ijpqa.11.3.6.
  21. Kashid VAK, Nikam VKN, Somwanshi SBS, Dolas RTD, Dhamak RT, Gaware VMG, et al. Brief overview of pharmaceutical facility validation. J Curr Pharm Res. 2014;4(2):1134-7. doi: 10.33786/JCPR.2014.v04i02.004.
  22. Pasupuleti S, Reddy S, Supriya S. A review on pharmaceutical process validation and its significance. Int J Mod Pharm Res. 2020;4(4):132-9.
  23. Varshney P, Shah M, Patel P, Rohit M. Different aspects involved in process validation. Innovare J Sci. 2013;1(2):16-9.
  24. WHO Expert Committee on Specifications for Pharmaceutical Preparations WHO. Technical report series GMP: guidelines on the validation of manufacturing processes.
  25. Sharma S, Singh G. Process validation in pharmaceutical industry; an overview. J Drug Deliv Ther. 2013;3(4):184-8. doi: 10.22270/jddt.v3i4.582.
  26. Jyakhwa U, Joshi D, Ashok K, Chikanbanjar N. A review article on concurrent process validation. C R J. 2020;1(1):48-54.
  27. Raul SK, Padhy GK, Mahapatra AK, Charan SA. An overview of concept of pharmaceutical validation. Res J Pharm Technol. 2014;7(9):1081-90.
  28. Sharma S, Khurana G, Gupta R. A review on pharmaceutical validation and implications. Int J Pharm Biol Res. 2013;1(3):100-4.
  29. Alam S. Pharmaceutical process validation: an overview. J Adv Pharmavy Educ Res. 2012 May 1;2(4):185-200.
  30. Chandani Y, Rajat V, Anju G. Aspects of pharmaceutical process validation: a review. Int J Pharm Pharm Res. 2018;14(1):55-66.
  31. Kant C, Nautiyal U, Kumar MS, Verma VV, Singh R. Process validation: an overview. Asian Pac J Health Sci. 2014;1(1):42-7. doi: 10.21276/apjhs.2014.1.1.7.
  32. Nikam UAN, Jadhav AVJ, Salunkhe VRS, Magdum CSM. An overview of pharmaceutical process validation of solid dosage form. J Curr Pharm Res. 2013;3(2):824-35. doi: 10.33786/JCPR.2013.v03i02.006.
  33. Kaur G, Rana AC, Bala R, Seth N. an Overview: the Role of Process Validation in Pharmaceutical Industry. Int Res J Pharm. 2012;3(1):25-7.
  34. Nandhakumar L, Dharmamoorthy G, Rameshkumar S, Chandrasekaran S. An overview of pharmaceutical validation: quality assurance view point. Int J Res Pharm Chem. 2011;1(4):1003-14.
  35. Kulkarni S, Panda A, Tiwari R. Pharmaceutical process validation: A key requirement for quality attribute. Res J Pharm Technol. 2014;7(1):74-7.
  36. Khot SR, Khobare RS, Patil PS, Patil SV. Review article process validation as quality assurance tool. Int J Creat Res Thoughts. 2021;9(7):23-39.
  37. Prabu SL, Suriyaprakash TNK, Thirumurugan R, Shanmugarathinam A. Process validation: a review. Pharma Times; 2014. 46(4):12-5.
  38. Singh SP, Dhaker K, Namdev A, Khinchi MP, Bhatnagar S. A review on process validation. PharmaciaTutor. 2016;4(12):9-19.
  39. Sarvani V, Elisha RP, Pola LM, Rao CB. Process validation: an essential process in pharmaceutical industry. Int J Med Chem Anal. 2013;3(2):49-52.
  40. Jatto E, Okhamafe A. An overview of pharmaceutical validation and process controls in drug development. Trop J Pharm Res. 2002;1(2):115-22. doi: 10.4314/tjpr.v1i2.14592.
  41. Verma P, Madhav NVS, Gupta V. A Review article on Pharmaceutical Validation and Process Controls. J Pharm Innov. 2012;1(7):51-60.
  42. Kathiresan K, Moorthi C, Prathyusha Y, Gade BR, Manavalan R, Reddy M. An overview on pharmaceutical validation. Res J Pharm Technol. 2010;1(4):1026-35.
  43. Bonthagarala B, Bonthagarala B, Lakshmi Sai PD, Sivaiah KV. Process validation: an essential process in pharmaceutical industry. Int J Adv Sci Res. 2015;1(4):179-82. doi: 10.7439/ijasr.v1i4.1781.
  44. Dara SKA, Tiwari RN. Pharmaceutical process validation: an industrial perspective. Res J Pharm Technol. 2014;7(7):810-4.
  45. Jain K, Agrawal P, Bharkatiya M. A review on pharmaceutical validation and its implication. Int J Pharm Biol Sci. 2018;8(2):117-26.
  46. Sharma M, Agarwal S, Agarwal S, Sharma M. Prospective validation: a review. J Pharm Innov. 2015;4(3):1-7.
  47. Sharma A, Saini S. Process validation in pharmaceutical industry: a review. Pharm Sci Monitor an International Journal of Pharmaceutical Sciences. 2013;4(3):342-54.
  48. Paruchuri R, Trivedi S, Pavuluri G, Prasanthi B, Kumar S. Process validation of finasteride tablets. Int J Pharm Chem Biol Sci. 2012;2(1):11-28.
  49. Sharma S, Khurana G, Gupta R. A review on pharmaceutical validation and its implications. Indian J Pharm Biol Res. 2013;1(3):100-4. doi: 10.30750/ijpbr.1.3.14.
  50. Lavanya G, Sunil M, Eswarudu MM, Eswaraiah MC, Harisudha K, Spandana BN. Analytical method validation: an updated review. Int J Pharm Sci Res. 2013;4(4):1280.
  51. Kashid VAK, Nikam VKN, Somwanshi SBS, Dolas RTD, Dhamak KBD, Gaware VMG et al. Brief overview of pharmaceutical facility validation. J Curr Pharm Res. 2014;4(2):1134-7. doi: 10.33786/JCPR.2014.v04i02.004.
  52. Singh SP, Dhaker K, Namdev A, Khinchi MP, Bhatnagar S. A review on process validation. PharmaciaTutor. 2016;4(12):9-19.
  53. Prabu SL, Suriyaprakash TNK, Thirumurugan R, Shanmugarathinam A. Process validation: a review. Pharma Times; 2014. 46(4):12-5.
  54. Kulkarni S, Panda A, Tiwari R. Pharmaceutical process validation: A key requirement for quality attribute. Res J Pharm Technol. 2014;7(1):74-7.
  55. Guide to inspections of oral solid dosage forms pre/post approval issued for development and validation. Washington, DC: US Food and Drug Administration; 1994.
  56. Process validation: general principles and practices by FDA January 2023.

Photo
Swati Jagtap
Corresponding author

Department of Pharmaceutical Quality Assurance, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.

Photo
P. B. Jadhav
Co-author

Department of Pharmaceutical Quality Assurance, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.

Photo
Vinod Bairagi
Co-author

Department of  Pharmacology, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.

Swati Jagtap, P. B. Jadhav, Vinod Bairagi, Pharmaceutical Validation: A Review, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 1, 399-409. https://doi.org/10.5281/zenodo.10531821

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