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New product with three strengths: 1 0 , 2 0 , 4 0 mg tablets compressed from a common blend ( tablets are 1 5
New product with three strengths: mg tablets compressed from a common blend tablets are mg in size, all same shapeCommon granulation is manufactured using a wet granulation process and dried in a fluid bed. The dried granulation is milled and then blended with a lubricant before being compressed into tablets. They are not coated.All strengths will be equally in demand, and the sales team will require two batches per strength at the time of product launch.All requirements for completion of Stage of process validation are done and documented.Also, all equipment and facilities are installed and qualified for use.Critical Quality Attributes identified for the product are tablet assay, content uniformity, and dissolution. The Critical Process Parameters identified are the wet granulator rotor speed, comil screen size, comil speed, lubrication blend time, tablet weight, and tablet strength.Risk assessment of the process prior to the start of Stage identified blend uniformity and content uniformity of the tablets as the highest risks.Propose a Stage and Stage process validation plan for LIUthium Im not asking you to write a validation protocol, but I am asking that you outline a plan for Stage that describes and justifies the number of batches and what you will test during the manufacturing of those batches. What are the criteria for a successful completion of Stage After Stage is completed, what is your proposal for Stage What will you test? How often?
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