IMPROVING THE PERFORMANCE OF PHARMACEUTICAL TABLET PRODUCTION USING SIX SIGMA METHODOLOGY (MODULATION ON DIGESTIVE ENZYME TABLET)

Each company is expected to develop specifications for their products to be accommodated with the inspection guide of pharmaceutical quality control. After product analysis for (X) pharmaceutical company it was noticed that 84.5% of defects were attributed to tablet department while 14.1% and 1.4% for ampoule and syrup departments respectively so it was valuable to solve the tablet department problems. Data was collected for three months for two types of tablets which were analgesic tablet (AT) and digestive enzyme tablet (D.E.T). D.E.T was chosen for further study due to its high percent of defect. By using six sigma methodology to analyze the collected data it was found that the major problem was in tablet microbiological test 85.9% rather than the physical problem 14.1%. D.E.T was subjected to study the variables affecting the bacterial count like raw material, process environment and microbiological analysis accuracy. It was found 66.7 of the problem caused by the variation in process environment. By using factorial design for three variables it revealed that the cleaning and disinfection methods were the most affecting factor that caused the total variation in the overall process. Seven remedies for cleaning were studied and each remedy was rated for each criterion using a special scaling system. It was noticed that the manual cleaning was the most effective method since it lowered the bacterial count of the coating solution to 285 cfu/ml and affected on sigma level to be 4.2 σ which exceeded the target (not more than 500 cfu /ml). Six Sigma methodology is a promising method for improving the pharmaceutical tablet production and achievement its quality control