Sree Karumuri, Swathi (2012) Process Validation Of Griseofulvin Tablets. Masters thesis, Sankaralingam Bhuvaneswari College of Pharmacy, Sivakasi.
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Abstract
The present study is “Process Validation of Griseofulvin”. The company is involved in the manufacturing and distribution of a wide range of Pharmaceutical products. The present study “Process Validation of Griseofulvin 375 mg Tablets”, is designed in meeting the US-FDA requirements to scientifically prove that the finished product meet its predetermined specifications and Quality attributes. The major objective of the study is to systemically conduct the validation studies pertaining to the manufacturing activities of Griseofulvin 375 mg Tablets. A validation protocol is established and based on that each stage of manufacturing process is to be monitored. Three consecutive batches of Griseofulvin should be validated. Samples are to be collected from respective stages and appropriate tests are to be carried out depending on the validation protocol. Results of all the tests are to be recorded, compared and based on that documentary evidence should be established to confirm that the manufacturing process of Griseofulvin consistently meet its predetermined specifications and Quality attributes. All the raw materials used in the manufacturing of Griseofulvin 375mg Tablets, were tested as per the given specifications and the results were within the limits. Hence the validation of raw materials was concluded. The equipment used in the manufacturing of the Griseofulvin 375mg Tablets were checked for their Installation, Operation and Performance Qualification and concluded. The dry mixing time of 5 minutes is concluded as validated mixing time at fast speed. The desired granular mass was obtained between impeller amperage 1.8-2.0 amps. Resultant granules after drying and milling have desired flow properties. All the three batches resulted in granules with desired flow and compaction, which is evident from data of compression tablets. Hence the granules stage of Griseofulvin 375 tablet is concluded as validated at impeller amperage of 1.8-2.0 amps. According to observations during drying for all three batches, it was concluded that only air drying the granular material after granulation is required till the LOD is NMT 1.0%. The blending time of 30 minutes is concluded as validated blending time at slow speed of blender for Griseofulvin 375 blending, when the process is performed in 2000 litres capacity Octagonal blender for a batch size of 537.6 kg. From the dissolution profile it was concluded that the compression process was validated. From the weight build up it was concluded that the validation of coating was concluded. From the finished product results it was concluded that the process validation of Griseofulvin 375mg Tablets was concluded.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Griseofulvin Tablets; Griseofulvin 375 mg Tablets |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 26 Sep 2017 06:27 |
| Last Modified: | 26 Sep 2017 06:27 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/3334 |
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