Author(s): Anushka Sathe, Shinde Ganesh S, Jadhav Ravindra S, Khule Shubham, Madhvi Joshi, Bhawar Kartik, Gade Supriya, Kharat prapti, Bhoir Bhumika, Diksha Bhande

Email(s): Email ID Not Available

DOI: 10.52711/2349-2988.2026.00032   

Address: Anushka Sathe1, Shinde Ganesh S1*, Jadhav Ravindra S2, Khule Shubham1, Madhvi Joshi1, Bhawar Kartik1, Gade Supriya1, Kharat prapti1, Bhoir Bhumika1, Diksha Bhande1
1Department of Pharmaceutics, Institute of Pharmacy, Loni.
2Department of Phgarmacognosy, Institute of Pharmacy, Loni.
*Corresponding Author

Published In:   Volume - 18,      Issue - 2,     Year - 2026


ABSTRACT:
Current Good Manufacturing Practices (cGMP) form the backbone of quality assurance in the pharmaceutical industry, ensuring that medicinal products are consistently manufactured and controlled to meet established standards of safety, efficacy, and quality. cGMP encompasses a comprehensive set of regulatory principles covering all stages of pharmaceutical production, including facility design, equipment qualification, material control, validated manufacturing processes, documentation systems, and quality management practices. Regulatory authorities such as the USFDA, WHO, EMA, and CDSCO enforce cGMP requirements to minimize risks that cannot be detected through final product testing alone, including contamination, mix-ups, deviations, and data integrity failures. Over time, cGMP has evolved from a prescriptive compliance model to a science- and risk-based quality system integrating modern concepts such as Quality by Design, Quality Risk Management, Process Analytical Technology, and continuous improvement. Global harmonization of GMP standards through WHO, ICH, PIC/S, and national regulations has facilitated international regulatory convergence and strengthened oversight of global supply chains. This review outlines the fundamental principles, regulatory frameworks, and key components of GMP, with emphasis on quality management, validation, documentation, personnel, premises, and inspection systems. Understanding and effective implementation of cGMP are essential for maintaining regulatory compliance, ensuring consistent product quality, and protecting patient health.


Cite this article:
Anushka Sathe, Shinde Ganesh S, Jadhav Ravindra S, Khule Shubham, Madhvi Joshi, Bhawar Kartik, Gade Supriya, Kharat prapti, Bhoir Bhumika, Diksha Bhande. Review on Current Good Manufacturing Practices. Research Journal of Science and Technology. 2026; 18(2):232-8. doi: 10.52711/2349-2988.2026.00032

Cite(Electronic):
Anushka Sathe, Shinde Ganesh S, Jadhav Ravindra S, Khule Shubham, Madhvi Joshi, Bhawar Kartik, Gade Supriya, Kharat prapti, Bhoir Bhumika, Diksha Bhande. Review on Current Good Manufacturing Practices. Research Journal of Science and Technology. 2026; 18(2):232-8. doi: 10.52711/2349-2988.2026.00032   Available on: https://www.rjstonline.com/AbstractView.aspx?PID=2026-18-2-15


REFERENCES:
1.    Ravishankar Ahirwar. Good Manufacturing Practices (GMP) compliance in the pharmaceutical sector. Int J Innov Eng Res & Manag. 2025; 12(2):51–55. 
2.    Jameela Helen Jacobs, Margret Chandira R, Deepu S, Benny KJ. A glance to the story of Good Manufacturing Practices for pharmaceuticals. J Biomed Pharm Res. 2020; 9(3). doi:10.32553/jbpr.v9i3.752
3.    Pallavi Gorukanti, Satheesh Jogala, Narender Boggula, Sucharitha Makula. Good Manufacturing Practices and documentation in pharmaceutical production: a comprehensive review. Asian J Pharm Res Dev. 2025; 13(6):86–95. doi:10.22270/ajprd.v13i6.1676
4.    Shinde G, Godage RK, Jadhav RS, Manoj B, Aniket B. A Review on Advances in UV Spectroscopy. Research Journal of Science and Technology. 2020; 12(1):47-51.
5.    Akash Sharma, Vriti Gamta, Gaurav Luthra. The importance of Good Manufacturing Practices (GMP) in the healthcare industry. J Pharm Res Int. 2023; 35(18):75–90. doi:10.9734/jpri/2023/v35i187394
6.    Shinde GS, Rao PS, Jadhav RS, Kolhe P, Athare D. A review on chromatography and advancement in paper chromatography technique. Asian Journal of Pharmaceutical Analysis. 2021; 11(1):45-8
7.    Al Azawei A, Loughrey K, Surim K, Connolly ME, Naughton BD. The management of good manufacturing practice (GMP) inspections: a scoping review of the evidence. Front Med (Lausanne). 2025; 12:1687864. doi:10.3389/fmed.2025.1687864
8.    Poli M, Quaglierini M, Zega A, Pardini S, Telleschi M, Iervasi G, Guiducci L. Risk management in Good Manufacturing Practice (GMP) radiopharmaceutical preparations. Appl Sci. 2024; 14(4):1584. doi:10.3390/app14041584
9.    Shinde, G. S., Jadhav, R., Vikhe, D., & Kote, R. B.Development and evaluation of herbal fast disintegrating tablet of Achyranthes aspera linn root extract. Asian Journal of Pharmacy and Technology, 2024:14(2), 119-122.
10.    Jurun Mclean. Good Manufacturing Practices (GMP) in pharmaceuticals: Ensuring quality and safety. Int J Pharm. 2023; 13(6):3–4. doi:10.37532/2249-1848.2023.13(6).74
11.    Sanjay Kumar Jain, Rajesh Kumar Jain. Evolution of GMP in Pharmaceutical Industry. Research J. Pharm. and Tech. 2017; 10(2): 601-606. doi: 10.5958/0974-360X.2017.00118.4
12.    Hemanth KG, et al. Pharmaceutical Defects: A critical review on defects of various dosage forms and regulatory impacts. Research Journal of Pharmacy and Technology. 2020 Sep; 13(9):4505–8. doi: 10.5958/0974-360X.2020.00794.5
13.    Shinde, G. S, Jadhav R S, Tambe V B, Kote R B.RP-HPLC Method Development and Validation of Lamivudine, Zidovudine and Nevirapine in Bulk and Dosage form using UV Detector." Research Journal of Pharmacy and Technology 17.10 (2024): 5011-5015
14.    Godge RK, Shinde GS, Joshi S. Simultaneous Estimation and Validation of Dapagliflozin and Saxagliptin in Bulk Drug and Dosage Form by RP-HPLC. Research Journal of Science and Technology. 2019; 11(1):59-63
15.    Raul S, Padhy G, Mahapatra A, Charan S. An Overview of Concept of Pharmaceutical Validation. Research Journal of Pharmacy and Technology. 2014 Sep; 7(9):1081-90. 
16.    Shinde GS, Jadhav RS, Kote RB, Kadam AJ, Bankar AA. Bioanalytical Method Development and Validation of UV Spectrophotometric Method for Estimation of Metformin Hydrochloride in Urine Sample. Asian J Res Chem. 2024; 17(2):93–6. doi: 10.52711/0974-4150.2024.00019
17.    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
18.    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.
19.    Anju G, Pandey P. Process Validation of Pharmaceutical Dosages Form: A Review. Biomedical Journal of Scientific and Technical Research. 2017; 1(5):1467–75.

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