QUALITY CONTROL IMPROVEMENT MONTHLY REVIEW DASH BOARD (QC-01 & QC-02) April-2020 to April- 2022

Feb -20. QUALITY CONTROL IMPROVEMENT MONTHLY REVIEW DASH BOARD (QC-01 & QC-02) April-2020 to April- 2022.

ASPIRE The Idea Engine QUALITY CONTROL - ACULIFE.

It makes job easier. It increases output. It improves quality. It reduces cost. It eases the burden of supervision. ADVANTAGE.

CONTENTS. Idea Owner Site Coach (Ravindra & Hemadri) Master Coach (Prahalad Mane ) Site SPOC (Rushang & Bhoomi) Idea Implementer.

5. Ideas Categorization. IL1 Specific ideas identified based on fact base, brainstorming etc. IL2 Idea refined based on benchmark constraints , exploring options, trending or analyzing historical data IL3 Idea accepted in principle by business heads/ customer managers for detailed validation and responsibility identified IL4 Idea implementation in progress IL5 Idea implemented and tracking impact.

6. Idea Generation. AutoSave E] 9 Aspire Idea Log - Excel Search Help Aculife Laptop (029) AL Share File Clipboard 626 Home Insert Calibri Page Layout 10 Font Formulas Data Review View 12B Wrap Text. Merge & Center Alignment cz Comments Ideas Ideas IDEAS GENERATED IN QUALITY CONTROL Status S ecific ideas identified based on fact base, brainstormin etc. Idea refined based on benchmark constraints . e lorin o •ons, trerdi or ana zin historical data Idea acce din ringi Ie b tn•siness heads/ customer man ersfor detailed validation ard res onsibilit Idea im lementationin ro Tess Idea im lemented and trackin im act Conditional Format as Cell Formatting v Table v Styles v Styles 0-10 min saving IO- 30 min saving 30 min savin A ualit or safet related im ment Oesi n. GMP or olic constraints Site level im act hence need consensus from other Needs assessment arnd investment apprcwal Internal decision execution b site Insert Format Cells artment or need some en ineerin de Sort& Find & Filter v Select v Editing n and then Feas;• Idea Targ Current Statu 12 Idea N' 2 oat 12.06.2020 Idea log Dep QC2 QC2 Categ General 96 Number Feasibilit Impa Malti Malti Idea Ovne seial Nex •ev•e Idea Implementa Plan SOP has been Micr 0b iologg Microbiology • As per current sop AUSCH/CRP'QCSi218. sample receipt register for microbiology lab. different register is maintained for sample recipt in microbiology lab ard different entry is taken for bic&rden. sterility. BET. LPC Moderate and MLT. •After barin storming new design is prepared for sample receipt logbcm>k which cover all test in single entry with all traceability Which save time for sample receipt. • current sop AUSCF+CRP'QCSQ12. Bioburder, testing procedure for bulk and pre sterile samples stated . bioburden testing performed by spread plate method for that sample filteration is not possible. The sample name is Nirpid 20 Nirpid and prc•pofol injection. •After brainstorming , discussion and trail it is concluded the filteration is possible by using ddent. • Using this filtration for above said samples, we can reduce marwal intervention , get more acut ate result instead of spread plate method using muarnum arrunnt of sample. as for spread plate methcd minirrwm quantity is tested as representative of whole sam I ml of sam while for fi t ion method 301071202 revis•ed and made effective as per Idea 07-12-2020 Complet i oate 07-01-2020 07-06-2020 sop has been revisved and made effective as per Idea Sheeti Type here to search completed completed ENG 17-09-2020.

Feb -20. Quality control improvements. Sr.No Improvement proposed / implemented Work simplification attachments 1 Display of Visual AIDS for easy references to analysts Idea owner : Prahalad Idea Executor : Bhoomi & Amish Fish bone , do’s and don’t s display in lab Displayed on 10 th April in both labs.

Sr.No . Improvement proposed / implemented Work simplification attachments 2 Start of QC Oath and to share learning from investigation both at QC-01, and QC-02 lab Idea owner & Executor : Prahalad This covers easy learnings and stay aware on cGMP requirements, like data integrity, online reporting, GDP, safety precautions followed by root cause of non conformance along with preventative measure to other analysts. QC Oath is schedule on day first of each week ( 10 to 15 minutes) QC-02, implemented on 13/04/2020 QC-01, Completed on 15/04/2020.

Sr.No . Improvement proposed / implemented Work simplification attachments 3 Demonstration purpose of pipette rinsing and observations Idea owner : Prahalad Idea Executor : Meet / Monalisa After pipette rinsing , analyst should visually inspect the pipette for any droplet adhere to wall of the pipette . Should avoid using such pipettes . For effective cleaning once the results are reviewed the pipette shall be kept for soaking in plastic cylinders filled with Teepol solutions, same should be easy available on analyst work bench. This will also avoid breakages of pipette in wash room. Completed QC-02, 13/04/2020 QC 01, 15/04/2020.

Sr.No . Improvement proposed / implemented Work simplification attachments 4 Demonstration purpose of pipette rinsing and observations in IPQC2 Idea owner& Demonstrater : Prahalad After pipette rinsing , analyst kept pipette in cylinder after use. This will also avoid breakages of pipette in wash room. Completed QC-02 05/05/2020.

Sr.No . Improvement proposed / implemented Work simplification attachments 5 Earlier the muffle furnace was on platform outside the fume hood in wet chemistry lab. Idea owner : Prahalad Idea Executor : Kirit It is shifted in fume hood to avoid direct contact with hazardous smoke. Completed QC-01, 06/05/2020.

Sr.No . Improvement proposed / implemented Work simplification attachments 6 Earlier there is not cupboard in guest change room entry. Idea owner : Prahalad Idea Executor : Rushang Install new cupboard , so Guest/auditor can easily wear apron /shoe cover. Compliance the entry/exit procedure. Completed QC-02, 05/05/2020.

Sr.No . Improvement proposed / implemented Work simplification attachments 7 Designated location for PPE and safety kit Idea owner : Prahalad Idea Executor : Shailesh Earlier PPE and safety kit was place inside the room. New location is identified for easy retrieval and use. The person can easily find the safety accessories in critical situation. Completed QC-02, 05/05/2020.

Sr.No . Improvement proposed / implemented Work simplification attachments 8 Controlled temperature FP sample room (R.No.: 189) not within temperature range (Higher side) Idea owner : Shailesh Idea Executor : Shailesh Immediately inform engineering person and rectify the problem and now it is within specified limit . Completed QC-01, 05/05/2020.

Sr.No . Improvement proposed / implemented Work simplification attachments 9 Reagent bottle stopper with name. Idea owner : Prahalad Idea Executor : Monalisa Earlier bottle stopper are not name So it may change during analysis and give false results/molarity. Currently all bottle stopper identified by solution number so it can not change and stop interchange of stopper event. Hence lab event is reduce. Completed QC-02, 05/05/2020 Completed QC-01, 06/05/2020.

Sr.No . Improvement proposed / implemented Work simplification attachments 11 RSD in UPLC is not achieved QC does not getting %RSD in the UPLC 12000250 product Nirmix peri The sample withdraw rate found 30, trail to be taken with 10 or 20 RSD found achieved and is below 0.5% against limit of NMT 2.0% ( 21/05/2020) 12 Retention time variation ( Shimadzue instrument) Drop in BP found in between analysis. Cleaning of inline mobile phase filters was the cause. Inline filters shall be cleaning on start of the week. Format shall be prepared as an immediate CA demonstration was provided to all analysts w.e.f. 01/06/2020 ( Amish and Haresh) 13 Brain stroming / Idea generation session Idea owner : Prahalad Idea Executor : Bhoomi We have started idea generation session under title “ Aspire Idea engine” in month of June-2020. This help analyst / doer to come out with there ideas on work simplification. At most 10 ideas are collected / logged and under IL1 to IL4 evaluation. Implemented idea 3 IL5.

Sr.No . Improvement proposed / implemented Work simplification attachments 10 Evaluation and Reduction in calibration frequency based on historical trend data Idea owner : Prahalad Idea Executor : Bhoomi & Kale Monthly, Three monthly instrument calibration data compilation and evaluation ( 22 instruments identified). This work simplification will reduce calibration cost ( chemical , standard etc) A: Inhouse calibrated instruments Phase Ia : 22 instruments ( 19/08/2020) Phase Ib : 24 instruments ( 19/11/2020) B: External calibrated instruments Phase II : 39 Instruments ( 19/01/2021) Phase Ia : inprogress Allocated / assigned activities. Draft justification and risk assessment shared with team. ( TCD 19/07/2020).

Sr.No . Improvement proposed / implemented Work simplification attachments 14 In house gas purification system for AAS Idea owner : Prahalad Idea Executor : Shailesh In house gas purification system was installed for AAS instrument gas system. It is cost saving initiative. It is earlier done by external vendor but developed in house and installed and working satisfactory. Photograph 15 Removal of intermediate stability station sample for all product. Idea owner : Ilisha & Rahul Idea Executor : Rahul QA stablity cell raised the CCN for removal of intermediate condition for all products. Removal of approx 400 sample per year. Per sample analysis cost is 5000rs , So 20 lakhs per annum saving with subsequent year. NA.

Sr.No Improvement proposed / implemented Work simplification attachments 16 Implementation of auto titration burette instead of manual burette. Idea owner : Prahalad Idea Executor : Rajesh This is saving time and increase more accuracy of titrimetric analysis. This lead to increase accuracy, secure solution stability and decrease error. Photograph 17 TOC test incorporate in BP instead of oxidizable substance. This will increase more compliance and product authentic data for TOC analysis of SWIF product..

Sr.No Improvement proposed / implemented Work simplification attachments 18 Easy assess for solid chemicals in weighing room Idea owner : Prahalad Idea Executor : Shailesh We had a separate area to store solid chemicals in wet chemical area . Analyst carry the bottle of chemicals in balance room and then he has to go and keep again in wet area . To avoid unrequired analyst move area to area , the required solid chemicals are kept in balance room Photograph 19 Cleaned / dried glassware segregation Idea owner : Prahalad Idea Executor : Ravindra After cleaning of glassware's are stored intact in a separate glass room area. This helps analyst to easily pick up the specified glassware's etc.

Sr.No Improvement proposed / implemented Work simplification attachments 20 Manual stamping of serial numbering is done on bound books. Any missing number during stamping was any issue also position varies Idea Owner : Prahlad Idea Executor : Moreshwar Word format – printer is in place , werein all those pages are charged on printer and automatically the numbering is done by printer Photograph 21 Log book for FTIR shall be obsoleted and e-sign facility shall be incorporated in the new template. Idea owner : Ravindra Idea implementer : Bhoomi FTIR instrument already attached with Lab solution software, and all data logs captured in the Lab Solution software, so there is no need of log book for extra work. 2. Tiamo - inprogress , 3. UV – Inprogress , 4. HPLC – Inprogress , 5. GC – Inprogress , 6. Balance – Inprogress , 7. Pass box, 8. pH meter 8. Column usage . TCD : Dec2020 Progress: FTIR – Implemented.

Sr.No Improvement proposed / implemented Work simplification attachments 22 Effective utilization of the space between the 2 balance table Idea owner : Ravinder singh Idea implementer : Bhoomi In weighing area, utilize space between two balance table by placing a 15 mm PVC sheet which can be used for keeping weighing boats, 1% Teepol solution for soaking of weighing boat. Balance area arranged properly and make area neat and clean. Labelling on acrylic hood itself to avoid gumming the instrument.

Sr.No Improvement proposed / implemented Work simplification attachments 23 Working table upgrade to fix the computer desk top and CPU under table Idea owner : Rushang Idea implementer : Rushang In QC documentation room, computer CPU and desk are on top of the table. The CPU need to located under table by drilling table top to connect the CPU system under table. Completed 24 Video training module development: Idea Owner & implementer : Prahalad Video module for critical operation to develop e.g. pipetting, balance , weighing operation etc to easy understand the technique to analyst and develop his skills Pipette, Balance Weighing operation, 21 cfr , HPLC, Water content, 25 LCD display of melting point not functioning Cost of display 3.0 lacs, as actual as per vendors quotation . Instrument display need to procure from new jersey. Inspected same by prahlad sir , all PCB IC ports removed and trimmed the wire for proper connectivity and then checked all IC ports . The Display found functioning satisfactory . No need to replace the display. 3 lacs saving ( 26/12/2020 ).

Sr.No Improvement proposed / implemented Work simplification attachments 25 Abnormal TOC results, vendor told to replace catalyst which cost around 1 lac Inspected the CO2 absorber and OXY-trap line . Replace CO2 absorber and manually cleaned / activated the oxytrap line. Improvement in base line and also TOC results found normal / trend. Saved 1 lac price of catalyst as actual 26 For Raman calibration , vendor standards were used those are chemicals and costing of same is 1.2 lac / year Those calibration standards are pure chemical / ACS grade and after verifying the same was procured locally and total cost is 18 thousand only.

Sr.No Improvement proposed / implemented Work simplification attachments 27 No space to keep weighing boats, spatulas, samples in weighing room Acrylic sheet is place and fixed on the table . This additional space is convenient for placing the accessories which are used during weighing operations 28 No partition to avoid cross contamination on analyst work benches Acrylic inhouse partitions are designed and are placed on work bench. This will keep segregated analyst glasswares , etcs on work bench and thus cross contamination can also be avoided..

Sr.No Improvement proposed / implemented Work simplification attachments 29 Time consuming of analysts for mobile phase filtration. One pump available and analyst waits for his / her turn till the assembly is free At present only 1 pump is available and in 1 st shift there is a analysts queue for mobile phase filtration. One vacuum scraped pump repaired and is installed in laboratory, so same can be utilized as alternate options. Same installed beneath workbench and is made in use 23/02/2021 (Approx. cost of new pump 25K saved) 30 Milli-Q purified water system is transferred to Wet lab for easy use and avoid water spillage problem Milli-Q water is used for sample and mobile phase preparation, at present it was available in instrument room # 2 ( HPLC room) and further there was no sink , also analyst use to go in this room for water purpose. Therefore relocated the Milli-Q system in wet chemistry lab itself , by which now easy asses to analyst in wet chemistry lab for mobile pphase and sample prepartion.

Sr.No Improvement proposed / implemented Work simplification attachments 31 Balance (Range 0.800 to 5.00 kg) installed in Instrument Lab-III for water loss study purpose. Early analyst use to go in micro department for using the Top pan balance, further it is not having printer facility. Relocated PM balance from PM department and with all qualification reinstalled in QC02 lab instrument Room#1. This balance is connected with printer. (Cost of balance 1.5 lacs) 32 Separate PC installed in Instrument Lab-I for validated Excel sheet. PC validated for excel sheet , calculation and is located in documentation room for easy access to analysts.

Sr.No Improvement proposed / implemented Work simplification attachments 33 Analytical balances (which had already been purchased but had not been installed in the lab due to a printer malfunction) were installed for routine use. Balance No:12000476 Analyst no need to weight for balance and complete the work on time. Balance is installed in weighing room along with printer after completion of qualification and calibration 34 The standardisation validity of two volumetric solutions was evaluated, and the standardisation time period was extended. 1. 0.01M EDTA (Daily to 30days) 2.0.1M Ammonium thiocyanate (Daily to 15days) Standardization time saved and In-process sample release time also reduced. Cost saved : Standard Cost : 500 / titration Approximate : 15000 / month On going simplification on reducing analytical time and standard cost.

Sr.No Improvement proposed / implemented Work simplification attachments 35 Manual chemical labels are made, which is a time-consuming task. Idea owner : Prahalad Mane Idea executor : Palak Pandya An Excel sheet of labels with links is created, allowing for only one time entry and n number of labels to be prepared / printed in a single session. There is no need to manually write information on the label. For preparing 10 to 20 labels, the analyst saves at least 30 minutes of time. Implemented 36 Manual TLC to photo documentation and print Idea owner : Ravindra singh Idea executor : Phusphak When spots are visible under UV lights, photocopies of TLC plates are difficult. A spare camera (QC03) was used, and related software was installed in a PC connection via the USB port. TLC photo-image capture under UV light, which can then be easily printed from a computer.Approximately 1.0 lac was saved in instrument costs. About 1.0 lacs cost saved for new instrument..

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Sr.No Improvement proposed / implemented Work simplification attachments 39 Review of material receipts on simplification process. Idea owner : Hemadri / Ravindra Executor : Prahalad To identify multiple receipts of same material / batch numbers in a month . Based on the review material list shall be provided to purchase team for their review and necessary actions on avoiding smaller receipts. List of material 460 approx. of sept month was reviewed and provided same to Bhavin bhai on 09/10/2021 40 Taligate / satellite samples implementation Identify bulk receipts in tones for feasibility of satellite sample. This will avoid sampling each containers / bags. Risk assessment / validation from vendors shall be approached Total 32 materials identified , list is send to Bhavin bhai for needful support. 05 th oct-21.

Sr.No Improvement proposed / implemented Work simplification attachments 41 Ambient standards are stored in a room / dessicator . Furthermore, QC03 control BOD incubators have been identified, which will keep those standards at a regulated temperature. Ambient standards are placed in a dessicator , and room temperature is measured. Changing it into a BOD incubator will provide temperature data, allowing any deviations to be identified and probed. Improved standard control in terms of storage condition 42 The temperature of the reference standard is manually recorded and stored in the refrigerator. The cooling incubator with data management has been purchased and installed. This will provide greater evidence and allow for more controlled temperature monitoring..