Comparison of Process Parameter of Lab Batches, Scale-Up Batches Exhibit Batches Commercial Batches

Authors

  • Rajaguru R Research Scholar, Department of Pharmaceutics, GITAM University Rudraram, Patancheru Mandal, Telangana, Hyderabad-502329, Telangana, India
  • Shalini G Department of Bioinformatics, The Tips Global Institute af?iliated to Bharathiar University, Coimbatore–641046, Tamil Nadu, India
  • Sai Priya R Department of Bioinformatics, Bharathiar University, Coimbatore–641046, Tamil Nadu, India
  • Sutheesh T Department of Pharmacy, Malla Reddy Institute of Pharmaceutical Sciences, Maisammaguda, Dhulapally, Post Komapally, Medchal Mandal, Secunderabad- 500100, Telangana, India
  • Naveen Kumar P Department of Pharmacy, Malla Reddy Institute of Pharmaceutical Sciences, Maisammaguda, Dhulapally, Post Komapally, Medchal Mandal, Secunderabad- 500100, Telangana, India

Abstract

The aim of the present work is to evaluate the critical process parameters and techniques and improve the quality and reduce cast and scaling up time. The pharmaceutical industry R & D refers to the process of successful progress from drug discovery to product development. The need to the target market are identified alternative product concept are generated and evaluate and single concept of selected for future development. The concept is a description of the from function and features a product and a usefully. The Scale up is the process as define to increasing the batch size or increasing different physical parameter the output of volume. The old process scale up techniques doesn’t involve studying the critical process parameters (Raw Process). The scale up batches industry to improve quality of the product in moving from Scale up batches/Exhibit Batches and validation batches. To improve the batches quality scale up of a process Transformation of small scale lab batches into commercial scale depended on experience and probability and involving the more technique. Due to this probability of success is less understanding of critical process parameters and process enables control of critical step process parameter during manufacturing and successful transformation from lab scale to Exhibit batches and commercial batches.

Keywords:

Scale up, Exhibit Batch Validation, Commercial Batches, R&D Process

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Published

2021-06-17

How to Cite

Rajaguru R, Shalini G, Sai Priya R, Sutheesh T, & Naveen Kumar P. (2021). Comparison of Process Parameter of Lab Batches, Scale-Up Batches Exhibit Batches Commercial Batches. Future Journal of Pharmaceuticals and Health Sciences, 1(3), 45–55. Retrieved from http://pharmasprings.com/index.php/fjphs/article/view/49

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Original Articles