{"product_id":"software-development-and-process-validation-in-tablet-manufacturing-von-dheeraj-t-baviskar-und-d-k-jain","title":"SOFTWARE DEVELOPMENT AND PROCESS VALIDATION IN TABLET MANUFACTURING","description":"\u003cp\u003eThe quality of the final product especially with  respect to the content of uniformity is primarily  determined by homogenicity of mixture. Validation of  process has become mandatory in U.S. as per GMP  regulations and also by a court action of 1993.  Present study involves validation of mixing, drying  and compression process for the manufacturing of  Paracetamol Tablet I.P.(500 mg) Paracetamol was  mixed with starch in a mass mixer as per the  developed formula. Samples were withdrawn from  predetermined locations in the mixer at different  time intervals 4 to 16 min and assayed  spectrophotometrically. The dried granules were  mixed with lubricants consisting of Talcum,  Magnesium Stearate and Sodium Lauryl Sulphate. The  samples were withdrawn from different predetermined  locations and assayed for Paracetamol content. From  analysis of data that 10 min was found to be optimum  mixing time during mixing process. Time required for  3 Kg of material  was 29 to 30 minutes for drying  studies and different compression parameters were   comply with requirements of I.P. 96. Self developed  software Pro-Vali was found to be useful in process  validation studies.\u003c\/p\u003e\u003cdiv class=\"aw-variant-hidden-subtitle-div\" id=\"aw-variant-subtitle-9783844399745\"\u003e\u003ch3\u003eProcess Validation\u003c\/h3\u003e\u003c\/div\u003e","brand":"Autorenwelt Shop","offers":[{"title":"Softcover - 9783844399745","offer_id":39497197813853,"sku":"9783844399745","price":59.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0940\/0622\/files\/6c54c117-f883-4aac-a1c5-dde3afe9d9be.jpg?v=1737700118","url":"https:\/\/shop.autorenwelt.de\/products\/software-development-and-process-validation-in-tablet-manufacturing-von-dheeraj-t-baviskar-und-d-k-jain","provider":"Autorenwelt Shop","version":"1.0","type":"link"}