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SEPTEMBER 2013

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Project: POTABLE WATER SAMPLING FREQUENCY REDUCTION Production units : Gemba :QCM Lab Location : 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

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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

Previous After 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. 10.3 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 = 247.2 hr. per year

Total Cost = 82,584/- Total Time = 123.6 hr. per year

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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 BMRs revised

Campus BMRs - 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 BMRs -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 16-17 pages

Before

Lengthy BMR

Media preparation separate for each

stage

After

Reduced pages

Combined media preparation for all

stages

Reduced

documentation

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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

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Process Map Before & After Kaizen

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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 55508 INR

Replaced the cotton with the screw cap bottles

Cost savings 1st year 35252 INR Cost savings 2nd year onwards - ~ 1 lakh

INR choking of the return air grills of the

Biosafety cabinet with cotton fibers is avoided

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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

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Project :HARMONIZATION OF PCG SOPs Production units : NA Gemba :QCM Lab Location : campus

Status : Before Kaizen Actions Taken During Kaizen

Results & Benefits Summary

20 SOPs for the MCB and WCB were being maintained Procedure was common but the documents were maintained strain wise

SOPs 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

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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

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Thank you

QC MICROBIOLOGY