To survive in demanding market and still to be successful, it is necessary to achieve high level product quality. It is derived from careful attention to a process design, control of the process, and in-process and end-product testing. Due to the complexity of today''s medical products, routine end-product testing alone often is not sufficient to assure product quality, So for this, the manufacturing process need to be controlled as integrated level and a good understanding of the processes and their performance is important. The process breaking down each individual steps, determine critical and non-critical steps. Every critical step should be scientifically planned and executed and documented appropriately in order to have effective and efficient. So here we go on the Prospective type of process validation of Loperamide Hydrochloride B.P 2 mg tablets, Initial three consecutive process batches of same size method, equipment and validation criteria were taken. The feedback indicated that this process is implemented as intended to use and data provide high degree of phenomenal assurance that the manufacturing process produce product that meet its predetermined specification and quality attributes.
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