1 SEPTEMBER 2013

2 Project: POTABLE WATER SAMPLING FREQUENCY REDUCTION Production units : Gemba :QCM LabLocation : campus Status : Before Kaizen 31 potable water sampling points tested for Total viable count and pathogens {number of tests-6] once in 15 days Evidence on the possible risk involved in reducing the testing frequency was gathered and recommendation of any control measure required on the risk identified for 31 potable water sampling points located at SFP, IFP, PFP and other facility was identified. Actions Taken During Kaizen

3 Results & Benefits Summary Process Map Before & After Kaizen Risk assessment being performed by assessing the mode of failure with control measures. Risk rating being evaluated by multiplying the risk level (severity) with available control measures. Based on the assessment sampling points was recommended for a sampling frequency of once a month PreviousAfter kaizen Total sampling points analyzed = 31 points analyzed for every 15 days Total sampling points analyzed = 31 points analyzed for every one month Media Cost : for each analysis 160/- Rs. 160 * 31 (sampling points) = 4960/- * 2 (monthly twice) = 9920/- 4960/- per month Filter paper: For Each analysis 10/- Rs 10* 155(no. of filter papers for 31 sampling points) = 1550/- (for 15 days) * 2 = 3100/- per month 1550/- per month Man Power : For each analysis 20minutes 20 * 31 (sampling points) = 620 minutes for 15 days 620 * 2 = 1240 minutes per month or 20.6 hr hours per month HDPE Sampling Bottles : For each analysis 1 bottle per sampling point = 12/- per bottle 12 * 31 = 372/- Rs. For 15 days, 372*2 = 744/- 372/- per month Total Cost = 1,65,168/- Total Time = hr. per year Total Cost = 82,584/- Total Time = hr. per year

4 Project :BMR REVISION Production units : NA Gemba :QCM Lab Location : campus Status : Before Kaizen Actions Taken During Kaizen Results & Benefits Summary Process Map Before & After Kaizen BMR is lengthy and time consuming to fill them Repetitive entries Signatures required in many place Media preparation activity stage wise Sterilization chart pasted in BMR -duplication of autoclave log book Park BMR’s revised Campus BMR’s - 16 numbers Reduction in number of pages, consolidation of raw material entry, media preparation activity for SF and IF combined, number of signatures reduced. Repetitive text removed Expected to be complete by 15/09/2013 Biological BMR’s -7 numbers Documentation time reduced by 60%; Preprinting of entries, number of signatures reduced Cost savings for paper & printing – to be estimated Reduction in Autoclave cycle therefore savings of power Manual entries reduced, thereby reducing errors, time. Eg – Tacrolimus Seed inoculum development checklist will be reduced from 27 pages to about pages Before Lengthy BMR Media preparation separate for each stage After Reduced pages Combined media preparation for all stages Reduced documentation

5 Project :CLOSED INOCULATION PROCEDURE FOR FERMENTERS Production units : SFP, IFP Gemba :QCM Lab Location : campus Status : Before Kaizen Actions Taken During Kaizen Results & Benefits Summary Small Molecules & Biologicals- Inoculation of fermenters was done using inoculation needle, which was essentially an open setup which required flaming before inoculating the fermenter Introduction of closed system, comprising of male and female connectors which are connected in a sterile manner, no exposure to the surrounding environment Biological- Replaced the glass transfer flask with the Heavy duty vacuum bottle with sterile connectors since inoculum volume is less Inoculum which is the basis for the start up for fermentation is not exposed to the external non clean environment Removal of flame- safety aspect Presence of sterile filter assures sterility

6 Process Map Before & After Kaizen

7 Project :REPLACEMENT OF COTTON PLUGS WITH SCREW CAPS Production units : NA Gemba :QCM Lab Location : campus Status : Before Kaizen Actions Taken During Kaizen Results & Benefits Summary Process Map Before & After Kaizen Cotton plugs were used for all the flasks and bottles used Cost for Cotton usage annually – INR Replaced the cotton with the screw cap bottles Cost savings 1 st year – INR Cost savings 2 nd year onwards - ~ 1 lakh INR choking of the return air grills of the Biosafety cabinet with cotton fibers is avoided

8 Project :FILTER INTEGRITY TESTING TRANSFERRED TO PRODUCTION Production units : SFP Gemba :QCM Lab Location : campus Status : Before Kaizen Actions Taken During Kaizen Results & Benefits Summary QC Microbiology was testing integrity of filters used in the fermentation as well as downstream process in production Total Number of filters tested -450 in five months Documentation involved One analyst used to be completely deputed for this activity Transferred the filter integrity testing to production since it does not involve any microbiology science Training of production personnel Reduced one man power requirement which resulted in saving 1.98 Lakhs Documentation reduced

9 Project :HARMONIZATION OF PCG SOP’s Production units : NA Gemba :QCM Lab Location : campus Status : Before Kaizen Actions Taken During Kaizen Results & Benefits Summary 20 SOP’s for the MCB and WCB were being maintained Procedure was common but the documents were maintained strain wise SOP’s reduced to 3 numbers Strain details entered in Annexure SOP preparation for new strains can be avoided Change controls reduced Maintenance of documents becomes simpler and easier to track

10 Project :STOP IN USAGE OF FLAME IN BIOSAFETY CABINETS Production units : NA Gemba :QCM Lab Location : campus/PARK Status : Before Kaizen Actions Taken During Kaizen Results & Benefits Summary Used flame for all the aseptic activities handled in the BSC Complete removal of usage of flame inside the BSC Safety compliance No disturbance in the air flow, no turbulence caused because there will be no heat generated in the cabinet Usage of gas cylinders reduced Process Map Before & After Kaizen

11 Thank you QC MICROBIOLOGY