Process Validation of Loperamide Hydrochloride B.P 2 MG Tablets. Prospective and Retrospective Process Validation

      Аннотация: 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. 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. Process validation of Loperamide Hydrochloride B.P 2 mg tablets, Initial 3 consecutive process batches of same size method, equipment and validation criteria were taken (for Prospective study), The review and study of the commercial minimum 10 batches data for Retrospective Study. The feedback of process validation 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.

Ключевые слова: trend analysis, Process Validation, Loperamide Hydrochloride, Quality System