Qualification of Equipment: Bin Blender and Compression Machine

Tirunagari, Mamatha; Raheem,; Qureshi, Husna Kanwal

doi:10.22270/jddt.v2i3.170

Cited by 1 publication

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“…Quali ication is an important part of a pharmaceutical manufacturer's quality assurance system: it should exhibit that facilities are suitable for their intended use and should also guarantee that the medicinal product is of suitable quality (Tirunagari et al, 2012). The validation master plan con-trols and describes the essential responsibilities and activities for quali ication & validation (Reddy et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

A Review on qualification of the tablet compression machine

Avinasha

Gangadharappa

et al. 2020

ijrps

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Validation is the art of designing andpracticing the designed steps alongside with the documentation. Validation is one of themostimportant steps in maintaining &achievingthe 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 an 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 theTablet 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 asappearance, punch Shape, punch diameter, upper punch, lower punch, hardness, weight variation, friability, and thickness.

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Section: Introductionmentioning

confidence: 99%