REVITAL HEALTHCARE (EPZ) LTD [Peaiment No. | 27706720 al Revision No | 02 ‘VALIDATION FOR BUSTER PACKING PROCESS Effective Date: | 01083019 Validation of Blister Packing Process Senet PATA —, icpaedb ‘oot ga Oe Gramed Lumen | Pred. Manager) ee) — eal Rapper 7 Tob Titer Signature Date: | sie Nlochoma | Gee , 05 (23/2019 | Ta Tab Te Samar Bai Lecten | @> roman) ter 5/69/2019 | Page 10f8REVITAL HEALTHCARE (EPZ) LTD | Document No. | 2106/20 Revision No | Or [ WaLibaTiOn FoR BUSTER PACKING PROCESS Contents + Introduction + Responsibilities + Equipment details + Validation + Packaging Equipment Qualification details + Installation qualification + Operational Qualification + Performance Qualification + Critical Parameters or steps + Sampling Inspection + Observation + Summary + Next validation due + Declaration Page 2 ofREVITAL HEALTHCARE (EPZ) LTD | Becument No. | 7/06/20 1. Introduction This Validation process describes in detall the activities required to execute the Validation phase ‘of quaication of REVITAL HEALTHCARE (EPZ) LTD. manufacturing facity of Mecca Devices 2. Responsibilities For this validation below persons are responsible forthe afferent tasks + QaManager Final Approval + QC Manager -Final Inspection + inspector “Inspection during trail + Production Manager “Process Verification *+ Production Supervisor Process setting Machine Setting Mold Setting + Plant Engineer(Electrician) ‘Machine installation Machine Fitness Check Maintenance of the machine Power connection of the machine Persons responsible ofthis Validation are confirming compliance withthe Infermation below: > Preparer ‘The preparer shal be the primary author ofthe document, or a delegate with an eppropriate level of understanding ofthe technical content ofthe document, The preparer signs to confirm ‘tha, to their knowledge, the document is complete, comples with the validation plan and is ‘ree fom erors. > Verifier “The verifier shal be the system owner or a delegate with an appropriate level of understanding ‘ofthe functionality ofthe equipment/system. The verifier signs o confirm tha, to ther knowledge, the document fufs all relevant testing requirements, is logical and executable and Is free from errors. > Quality Approval ‘The qually approver shall be the Qualty Manager ora delegate with an appropiate level of understanding ofthe qualty systems relevant to ths protocol. The quality approver signs to ‘confirm that the document complies with relevant quality systems can be adequately resourced in the time frame anticipated for execution and is free from errors. Page 30f8| REVITAL HEALTHCARE (EPZ) LTD [Peeument wo. |zin6720 Revision Nox | 0% { WaonTion FoR aUSTER PACKING PROCESS [ tfectve Dates | 01097035 3. Equipment Details . [Machine Name CHL Jeb ‘Machine Model — ax ~ eo [Total Load go Ew Machine Serial Number "5 2006701 [PowerRequired TS ‘Ait Consumption baa C/rin Mould Used EME SYRING 4, Validation Packaging validation is establishing documented evidence, which provide high degree of assurance that a specific packaging process performed, will consistently produce a pack, which meets predetermined specication, > Validation must be performed by person with the necessary education, background, training experience and qualification. > Validation program must be documented and approved. 5. Packaging Equipment Qualification details:- > Commissioned By REVITAL HEALTHCARE (EPZ) LTD. Cleaned, in routine operation : By REVITAL HEALTHCARE (EPZ) LTD. > The type of testing Labeling, lubrication, Power in-put et: > Number of people involved: 6 Nos > Purpose of Equipment to Pack the medical device > Target production rate 10-12 cyce/min. > location of equipment CClean Room (Blister Packing Aree) > Safety Consideration Emergency stop switch > Type of maintenance required :Preventive & Breakdown (Unfortunate) . Installation Qualification: > IQ protocol is checklist to ensure that the system or equipment is properly installed. > In this engineering drawing should be checked and updated as appropriate. 7. Operational Qualification:- > 0Q protocol will challenge to system to demonstrate that it can operate within specified parameters, > Challenge the upper and lower operating limits, to test the arocess and system. 8, Performance Qualification Page 4 ofREVITAL HEALTHCARE (EPZ) LTD | Socument No.: | 2/F106/20 “| PQ should performed in normal daily operation > Testing of each piece of equipment > Testing interaction between different pieces of equipment > Test all critical steps DELIVERY OF BLISTER FILM HEAT TREATMENT OF BLISTER FIM BLISTER FORMING FROM BLISTER FILM PRODUCT FILLING TO BLISTER L UNWINDING OF COATED PAPER PLAIN 360GSM tH PRINTING OF BATCH NUMBER, MFG. & EXP. SEALING OF BLISTER BY COATED PAPER PUNCHING/CUTTING FOR WASTAGE REMOVAL L ‘SECONDARY AND FINAL PACKAGING Page Sof 8REVITAL HEALTHCARE (EPZ) LTD | Secument No. | 206720 | Revision No.) | Ot | WAUoaTiON FoR BUSTER PACKING PROCESS Effective Date: | 01082015 BLISTER PACKAGING OPERTION LINE DIAGRAM 4 my Pea Page 60f8[REVITAL HEALTHCARE (EPZ) LTD [Becimentos J2fiosz0 Revision No. -VAIORTON FOR BUSTER PACKING PROCESS Effective Date 0.092055 9. CRITICAL PARAMETERS OR STEPS ‘VALIDATION ATE: 2 .4).281-2. aE |_ TEMPERATURE (°C) 1] TIME (SEC) FORMING | SEALING | FORMING/BLOWING | SEALING | VACUUME I 90 | 145 od janes ee |_ Io! 00 tor | 1¥o os ie = 2.00 Es 190 fa Ve og 14.00 | 122 [200 1S 23 [00 16100 12/7 [aos] 22 [zs [ro 10. SAMPLING INSPECTION. TIME QTY CHECKED ~_avRBEcT G08 200 22 Looe 200 Niel (2.00 Zoo We [1H o° 200 wi LU 00 | 200 28 11. OBSERVATION ‘Time | FORMING | SEALING | PRINTING | CUTTING | REMARK [geo | weroe| Note [oe ek [Failed 10.00 ole ole on ok Passed. v2.00 | ok ek oe ek | Passed (uioo | ee | of | oe | based 16.00] NoteEp ok [Wet eK Caled Page 7 of[REVITAL HEALTHCARE (EPZ) LTD [Beeumert No: [2706/20 Revision Wo 101 ‘VALIDATION FOR BUSTER PACKING PROCESS Effective Date: | 0:08.2019 11, SUMMARY: THE FOLLOWING PROCESS FOUND SUITABLE FOR THIS PRODUCT sy TEMPERATURE co TIME (SEC) | FORMING | SEALING) FORMINGTBLOWING | SEALING | [-tereo | re2 | Ivo] 65 iss rzio0 | U 2 | 196 ty Le [eseetedse ngcaeoee | | ee osama 12. Next validation due: after one year or prior to change the exiting paper, film or machine 13. Declaration: we all here declared that we have checked and verified the validation process and approving the above report to carry out regular’ process. Page Bf