Six Sigma: Process of Understanding the Control and Capability of Ranitidine Hydrochloride Tablet

    Published on:
    Journal of Young Pharmacists, 2011; 3(1):15-25
    Pharmaceutics | doi:10.4103/0975-1483.76415
    Authors:

    Chabukswar AR, Jagdale SC, Kuchekar BS, Joshi VD1, Deshmukh GR1, Kothawade HS, Kuckekar AB, Lokhande PD2

    MAEER’s Maharashtra Institute of Pharmacy, MIT Campus, Paud Road, Kothrud, Pune – 411 038,

    1Department of Production, Glaxo Smith Kline Pharmaceuticals Ltd., Ambad, Nashik – 422 010,

    2Department of Chemistry, University of Pune, Pune, Maharashtra, India.

    Abstract:

    The process of understanding the control and capability (PUCC) is an iterative closed loop process for continuous improvement. It covers the DMAIC toolkit in its three phases. PUCC is an iterative approach that rotates between the three pillars of the process of understanding, process control, and process capability, with each iteration resulting in a more capable and robust process. It is rightly said that being at the top is a marathon and not a sprint. The objective of the six sigma study of Ranitidine hydrochloride tablets is to achieve perfection in tablet manufacturing by reviewing the present robust manufacturing process, to find out ways to improve and modify the process, which will yield tablets that are defect-free and will give more customer satisfaction. The application of six sigma led to an improved process capability, due to the improved sigma level of the process from 1.5 to 4, a higher yield, due to reduced variation and reduction of thick tablets, reduction in packing line stoppages, reduction in re-work by 50%, a more standardized process, with smooth flow and change in coating suspension reconstitution level (8%w/w), a huge cost reduction of approximately Rs.90 to 95 lakhs per annum, an improved overall efficiency by 30% approximately, and improved overall quality of the product.

    Key words: DMAIC, process capability, ranitidine, six sigma.

     

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