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VOL. 4, ISSUE 3 (2019)
Process validation of sertraline film coated table
Authors
Govind Lovanshi, Deepak Kumar Gupta, Raju Choukse, Rakesh Patel
Abstract
The main Purpose of this study is to generate the sufficient data to establish the documentary evidence to confirm that the above Dosage form can be manufactured on commercial scale meeting all its quality attributes in a consistent manner. The study includes the validation of critical steps of manufacturing such as blending, compression and blister packing all process validation batches had been manufactured and validated in full compliance with cGMP requirement Based on the results of the validation data, it shall be concluded that the manufacturing process as it consistently produces the product of predetermined quality parameters. Hence it can be concluded that the manufacturing process of Sertraline hydrochloride 50 mg tablet was validated and was approved for routine production.
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Pages:23-30
How to cite this article:
Govind Lovanshi, Deepak Kumar Gupta, Raju Choukse, Rakesh Patel "Process validation of sertraline film coated table". International Journal of Pharmaceutical Science and Research, Vol 4, Issue 3, 2019, Pages 23-30
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