Process Validation of Loperamide Hydrochloride B.P 2 MG Tablets

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Details

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.

Autorentext

My Self the Quality Management Fellow,Believing in Quality & Ever Focus on Innovation and improvisation of Quality related system.Quality is never an accident it is always the results of high intention, sincere effort, intelligent direction and skillful execution, it represents the wise choice of many alternatives."Quality Can Earn Money"

Weitere Informationen

  • Allgemeine Informationen
    • Sprache Englisch
    • Autor Nilesh Kanani , Hasumati Raj , Laxmikant Jaiswal
    • Titel Process Validation of Loperamide Hydrochloride B.P 2 MG Tablets
    • Veröffentlichung 22.05.2013
    • ISBN 3659400734
    • Format Kartonierter Einband
    • EAN 9783659400735
    • Jahr 2013
    • Größe H220mm x B150mm x T7mm
    • Untertitel Prospective and Retrospective Process Validation
    • Gewicht 173g
    • Genre Medizin
    • Anzahl Seiten 104
    • Herausgeber LAP LAMBERT Academic Publishing
    • GTIN 09783659400735

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