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Reference: IT college

(i) List the important differences between the principles of (GLP and a relevant (ISO international standard. (ii) Outline (with examples) the important differences between the roles of (QC )and QA. (iii) Calculate the (Capability Index for the production process outlined in part b) below (The specification for this process is 45 +/ 2% w/v.) (iv) The target value for a production process producing a veterinary product is 20 mg/ml. Plot the CUSUM values from the following data obtained from five production batches. 20, 22, 19, 14, 13. (mg/ml) (V) Describe the important requirements a company should have in place to comply with GMP (vi) Write a short account on the benefits of lean Six Sigma . (vii) The following polysaccharide values ( % w/v) were obtained from 10 batches of a production process. 45.10 45.50 47.1 45.70 45.00 45.75 45.40 47.50 47.00 45.50 Using the data above plot a labelled Shewhart Quality Control Chart showing the warning and action limits. (viii) The next values obtained were 45.70 % and 47.5% values; what would this indicate about the process. (ix) List the useful indications from a process control chart that action is required to maintain a process within specification. (x) What values are plotted on a suitable graph to calculate the AQL (xi) Describe a typical sampling plan