Author(s): Darshan A. Salade, Kishor S. Arote, P. H. Patil, Vikas V. Patil, Amol R. Pawar

Email(s): kishorarote770@gmail.com

DOI: 10.52711/2231-5675.2022.00035   

Address: Darshan A. Salade*, Kishor S. Arote*, P. H. Patil, Vikas V. Patil, Amol R. Pawar
Department of Quality Assurance, Kisan Vidya Prasarak Sanstha's, Institute of Pharmaceutical Education, Boradi 425405.
*Corresponding Author

Published In:   Volume - 12,      Issue - 3,     Year - 2022


ABSTRACT:
Validation is the procedure which authorizing documentary evidence that proves the following process will consistently produce the product which leads to the expected result. According to GMP validation studies are important part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. Validation is the one of the important part in achieving and maintaining the quality of the final product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Process validation is an integral part of quality assurance as per cGMP. Validation and quality assurance will go hand in hand, ensuring the thorough quality for product. Process validation plays a key role in the pharmaceutical manufacturing process as it delivers a high degree of assurance and evidence that the process, which is being carried out gives out the uniform results, that is, it means the required specifications, which has been performed accurately. The purpose of this review is to present an introduction and general review on validation in pharmaceutical industry.


Cite this article:
Darshan A. Salade, Kishor S. Arote, P. H. Patil, Vikas V. Patil, Amol R. Pawar. A Brief Review on Pharmaceutical Validation. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):211-7. doi: 10.52711/2231-5675.2022.00035

Cite(Electronic):
Darshan A. Salade, Kishor S. Arote, P. H. Patil, Vikas V. Patil, Amol R. Pawar. A Brief Review on Pharmaceutical Validation. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):211-7. doi: 10.52711/2231-5675.2022.00035   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-3-9


REFERENCES:
1.    Anju G, Pandey P. Process Validation of Pharmaceutical Dosages Form: A Review. Biomedical Journal of Scientific and Technical Research. 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 Academic Journal of Pharmacy (SAJP). 2014;3(2):178–90.
3.    Harpreet K, Gurpreet S, Nimrata S. Pharmaceutical Process validation: A Review. Journal of Drug Delivery and Therapeutics. 2013;3(4):189–94.
4.    Ojha A, Bharkatiya M, Kitawat S. Pharmaceutical Process Validation of Solid Dosage Forms: a Review. World Journal of Pharmacy and Pharmaceutical Sciences. 2014;3(6):476–84.
5.    Paruchuri R, Trivedi S, Pavuluri G, Prasanthi B, M SK. Process Validation of Finasteride Tablets. International Journal of Pharmaceutical, Chemical and Biological Sciences. 2012;2(1):11–28.
6.    Aleem H, Zhao Y, Lord S, McCarthy T, Sharratt P. Pharmaceutical process validation: An overview. Proceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering. 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. The Pharma Innovation. 2020;8(6):950–8.
9.    Murthy N, K. C. Review article on process validation as a quality assurance tool a Theoritical approach. Internationale Pharmaceutica Sciencia. 2013;3(2):6–14.
10.    Karthick C, Kathiresan K. Pharmaceutical Process Validation: A Review. Journal of Drug Delivery and Therapeutics. 2022;12(1-s):164–70.
11.    Varshney P, Shah M, Patel P, Rohit M. Different aspects involved in process validation. Innovare Journal of Science. 2013;1(2):16–9.
12.    WHO Expert Committee on Specifications for Pharmaceutical Preparations WHO- Technical Report Series GMP: Guidelines on the Validation of Manufacturing Processes.
13.    Bhaishaikh IM, Chavan A V, Kadam VP, Desai S, Gurav NN. Process Validation: an Essential Process in Pharmaceutical Industry. World Journal of Pharmacy and Pharmaceutical Sciences. 2017;6(8):217–34.
14.    Sharma S, Singh G. Process Validation in Pharmaceutical Industry; an Overview. Journal of Drug Delivery and Therapeutics. 2013;3(4):184–8.
15.    Rachna P, Rana AC, Nimrata S, Rajni B. Introduction and General Overview of Pharmaceutical Process Validation: a Review. International Research Journal of Pharmacy. 2012;3(6):60–4.
16.    Jyakhwa U, Joshi D, Ashok K, Chikanbanjar N. A Review Article on Concurrent Process Validation. CR Journals. 2020;1(1):48–54.
17.    Raul SK, Padhy GK, Mahapatra AK, Charan SA. An overview of concept of pharmaceutical validation. Research Journal of Pharmacy and Technology. 2014;7(9):1081–90.
18.    Sharma S, Khurana G, Gupta R. A Review on Pharmaceutical Validation and Implications. International journal of Pharmaceutical and Biological Research. 2013;1(3):100–4.
19.    Alam S. Pharmaceutical process validation: An overview. Journal of Advanced Pharmavy Education and Research. 2012 May 1;2(4):185–200.
20.    Chandani Y, Rajat V, Anju G. Aspects of Pharmaceutical Process Validation: A Review. International Journal of pharmacy and Pharmaceutical Research. 2018;14(1):55–66.
21.    Kant C, Nautiyal U, Kumar MS, Verma VV, Singh R. Process Validation: an Overview. Asian Pacific Journal of Health Sciences 2014; 1(1):42–7.
22.    Nikam UA, Jadhav A V, Salunkhe VR, Magdum CS. An Overview of Pharmaceutical Process Validation of Solid Dosage Form. Journal of Current Pharma Research. 2013;3(2):824–35.
23.    Kaur G, Rana AC, Bala R, Seth N. an Overview: the Role of Process Validation in Pharmaceutical Industry. International Research Journal of Pharmacy. 2012;3(1):25–7.
24.    Nandhakumar L, Dharmamoorthy G, Rameshkumar S, Chandrasekaran S. An overview of pharmaceutical validation: quality assurance view point. International Journal of Research in Pharmacy and Chemistry. 2011;1(4):1003–14.
25.    Kulkarni S, Panda A, Tiwari R. Pharmaceutical process validation: A key requirement for quality attribute. Research Journal of Pharmacy and Technology. 2014;7(1):74–7.
26.    Khot SR, Khobare RS, Patil PS, Patil S V. Review article process validation as quality assurance tool. International Journal of Creative Research Thoughts. 2021;9(7):23–39.
27.    Prabu SL, Suriyaprakash TNK, Thirumurugan R, Shanmugarathinam A. Process validation: A review. Pharma Times. 2014;46(4):12–5.
28.    Singh SP, Dhaker K, Namdev A, Khinchi MP, Bhatnagar S. A Review on Process Validation. PharmaTutor. 2016;4(12):9–19.
29.    Sarvani V, Elisha RP, Pola LM, Rao CB. Process validation: An essential process in pharmaceutical industry. International Journal of Medicinal Chemistry and Analysis. 2013;3(2):49–52.
30.    Jatto E, Okhamafe A. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Tropical Journal of Pharmaceutical Research. 2002;1(2):115–22.
31.    Verma P, Madhav NVS, Gupta V. A Review article on Pharmaceutical Validation and Process Controls. Pharma Innovation. 2012;1(7):51–60.
32.    Jindal D, Kaur H, Patil RK, Patil HC. Validation – In pharmaceutical industry: Equipment validation: A brief review. Adesh University Journal of Medical Sciences and Research. 2020; 2(2):94–8.
33.    Pasupuleti S, Reddy S, Supriya S. A review on pharmaceutical process validation and its significance. International Journal of Modern Pharmaceutical Research. 2020;4(4):132–9.
34.    Kashid VA, Nikam VK, Somwanshi SB, Dolas RT, Dhamak RT, Gaware VM, et al. Brief Overview of Pharmaceutical Facility Validation. Journal of Current Pharma Research. 2014;4(2):1134–7.
35.    Kakad SB, Kolhe MH, Dukre TP. A review on pharmaceutical validation. International Journal of Pharmaceutical Quality Assurance. 2020;11(3):338–42.
36.    Kathiresan K, Moorthi C, Prathyusha Y, Gade BR, Manavalan R, Reddy M. An overview on pharmaceutical validation. Research Journal of Pharmacy and Technology. 2010;1(4):1026–35.
37.    Sandhya C, Bonthagarala B, Sovaiah KV, Lakshmi Sai PD. Process validation: An essential process in pharmaceutical industry. International Journal of Advances in Scientific Research. 2015;1(04):179–82.
38.    Dara SKA, Tiwari RN. Pharmaceutical process validation: An industrial perspective. Research Journal of Pharmacy and Technology. 2014;7(7):810–4.
39.    Jain K, Agrawal P, Bharkatiya M. A Review on Pharmaceutical Validation and Its Implication. International Journal of Pharmacy and Biological Sciences. 2018;8(2):117–26.
40.    Sharma M, Agarwal S, Agarwal S, Sharma M. Prospective Validation: A Review. The Pharma Innovation. 2015;4(3):1–7.
41.    Sharma A, Saini S. Process Validation in Pharmaceutical Industry: A Review. Pharma Science Monitor an International Journal of Pharmaceutical Sciences. 2013;4(3):342–54.

Recomonded Articles:

Author(s): Dipti G. Phadtare, Pawar Amol R, R.B. Saudagar

DOI: 10.5958/2231-5675.2016.00019.3         Access: Closed Access Read More

Author(s): Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani

DOI: 10.5958/2231-5675.2016.00030.2         Access: Open Access Read More

Author(s): K. Pramod, Shahid H. Ansari, Javed Ali

DOI:         Access: Open Access Read More

Author(s): G. Krishnamoorthy, C. Diana Priyadarshini, R. Senthamarai

DOI:         Access: Open Access Read More

Author(s): Sushil D. Patil, Sayali K. Chaure, Maswood Ahmed Hafizur Rahman, Prajkta U. Varpe, Sanjay Kshirsagar.

DOI: 10.5958/2231-5675.2017.00004.7         Access: Open Access Read More

Author(s): Kirthi A, Shanmugam R, Mohana Lakshmi S , Ashok Kumar CK, Padmini K, Shanti Prathyusha M, Shilpa V

DOI:         Access: Open Access Read More

Author(s): Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D

DOI:         Access: Open Access Read More

Author(s): Hamid Khan, Javed Ali

DOI: 10.5958/2231-5675.2017.00020.5         Access: Open Access Read More

Author(s): Yogita R. Indalkar, Aloorkar N.H.

DOI: 10.5958/2231-5675.2015.00028.9         Access: Open Access Read More

Author(s): Pinaz A. Kasad, K.S. Muralikrishna

DOI:         Access: Open Access Read More

Author(s): Santosh Gada, Anand Kumar Y, Saritha, C. Mallikarjuna Setty

DOI: 10.5958/2231-5675.2018.00036.4         Access: Open Access Read More

Author(s): Mansi J. Chaudhari, Suraj R. Chaudhari, Shailesh S. Chalikwar, Atul A. Shirkhedkar

DOI: 10.5958/2231-5675.2018.00008.X         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 

Popular Articles


Recent Articles




Tags