PROCESS VALIDATION OF ANTIMALARIAL DRUG: HYDROXYCHLOROQUINE SULFATE TABLETS USP 200 mg.

Vishalkumar Shashikant Modi
SSR College of pharmacy, Sayli Road, Silvassa, Dadra and Nagar Haveli, India - 396230.
Dimpi Rajesh Patel
SSR College of pharmacy, Sayli Road, Silvassa, Dadra and Nagar Haveli, India - 396230.
Parixit Rohitbhai Prajapati
SSR College of pharmacy, Sayli Road, Silvassa, Dadra and Nagar Haveli, India - 396230.
Tarasankar Basuri
SSR College of pharmacy, Sayli Road, Silvassa, Dadra and Nagar Haveli, India - 396230.
Shababano Shafiq Siddique
SSR College of pharmacy, Sayli Road, Silvassa, Dadra and Nagar Haveli, India - 396230.

Process validation ,quality assurance ,Hydroxychloroquine sulfate ,validation protocol ,

The main purpose of this research article is to study process validation of Hydroxychloroquine sulfate USP 200 mg Film coated Tablets. Validation is a very important step for producing a quality product. The various critical parameter is carried out at different stage of manufacturing process of tablets and if each step is properly validated then quality finished product is produces. This process validation gives the assurance of the product. In this present study the revalidation proce ss is carried out as the batch size had been increased. The various parameter involved are sifting, dry mixing, wet granulation, drying, milling, lubricating, compression and coating and this parameter are properly identified and evaluated as per validat ion protocol. Its result indicates that process validation data gives the high degree of assurance that the process produces the product meetings its predetermine specification and quality attributes.

6 , 2 , 2016