A Review on qualification of the tablet compression machine

Avinasha S (1) , Gangadharappa H V (2) , Hemanth Kumar S (3) , Gowrav M P (4)
(1) Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru, Karnataka-570015, India, India ,
(2) Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru, Karnataka-570015, India, India ,
(3) Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru, Karnataka-570015, India, India ,
(4) Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru, Karnataka-570015, India, India

Abstract

Validation is the art of designing and practicing the designed steps alongside with the documentation. Validation is one of the most important steps in maintaining & achieving the quality of the final product group after batch. The qualification of the equipment and systems are planning to carry out the tests and record the tests. We cannot be manufacturing the product, without equipment. If the equipment is validated, we can ensure that our product is of the top-quality. Validation of the equipment is known as Qualification. To making different kinds of dosage forms, various equipment’s are used. Here, this article concentrates on the equipment qualification for the Tablet compression machine. It gives in detail, qualification steps of the equipment, which is used for the manufacturing process through wet granulation. Qualification, an ideal step for equipment validation, is the action undertaken to demonstrate the intended use and performance of the utilities and equipment.  The individual steps of qualification such as design, installation, operational and performance qualification, were done in order to qualify the equipment. Blueprint of equipment validation was also included and the tablets were tested for physical parameters such as appearance, punch Shape, punch diameter, upper punch, lower punch, hardness, weight variation, friability, and thickness.

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Authors

Avinasha S
avi053196@gmail.com (Primary Contact)
Gangadharappa H V
Hemanth Kumar S
Gowrav M P
Avinasha S, Gangadharappa H V, Hemanth Kumar S, & Gowrav M P. (2020). A Review on qualification of the tablet compression machine. International Journal of Research in Pharmaceutical Sciences, 11(2), 1961–1967. Retrieved from https://ijrps.com/home/article/view/1040

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