i at NA STANDARD OPERATING PROCEDURE Navan Pharmaceuticals Ltd. Rupshi, Narayangani, Bangladesh LE: SAMPLING OF INTERMEDIATE, BULK, FINISHED & RETENTION SAMPLE —~T 2 T. ument No. | sOP/np/aasoas tssue Date October 14, 2019| RevisionNo| 06 _| Y Quality Assurance Review Date | October 13, 2022| Page 1 0f7 ~ v oT ye jeer ae Effective Date O1JAN2020 | copy No. copy || rtment — . \ OBJECTIVE ” ~ |] te ensure the cocumested procedure for sampling of intermediate, bulk, finished and retention samples. 2 q SCOPE \ | This procedure is applicable for sampling of intermediate, bulk, finished and retention samples are rnanufactured by Navana Pharmaceu'icals Ltd, DEFINITION oe in-process Control . — = Checks performed during prodictior in order to monitor and, # necessary, to adjust the process to | ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded a8 a part of in-process control. I Intermediate Product partly processed product that must undergo further manufacturing steps before it becomes 2 bulk ‘ product. » Bulk Product 1 Any processed material in loose form that has completed all processing stages up to, but excluding final packaging. | Finished Product ‘a tinished dosage form that has undergone all stages of manufacture, including packaging in its final container and labeling, “ Retention Sample 7 sample collected as part of the origine! sampling praess and reserved «tthe testing. Th ‘ catemtion sample shoulé be sufficient to allow for at feast two confirmatS@y/4nalyses, in 5 nape sat. reations may require om or more retention amples, ach af wich shou sna identified, packaged and sealed. id be Separately | 2.0 REFERENCE ries, No. 929, 2005, Annex 4NaVANA STANDARD OPERATING PROCEDURE _Navana Pharmaceuticals Ltd. Rupshi, Narayanganj, Bangladesh AMPLING OF INTERMEDIATE, BULK, FINISHED & RETENTION SAMPLE Document No. SOP/NP/QA/01S Issue Date October 14, 2019] Revision No| _06 | Rev.05, November 30, 2018 | Effective Dat 11 JAN peer ‘Supersedes ate | O1JAN2000 CopyNo. | copy Department Quality Assurance Review Date October 13, 2022| Page 2 of 7 5.0 6.0 7.0 %2_ ICH Q7A, Section 8.3, in-process Sampling and Controls 4.3. FDA, Section 21 CFR 211.110, Sampling and testing of in-process materials and drug products. 4.4 EU GMP, Annex 8, Sampling of Starting and Packaging Materials RESPONSIBILITIES 5.1 Executive / Officer, QA are responsible for in-process sampling in different stages during manufacturing and packaging of a product. 5.2. Asst. Manager, QA is responsible for the compliance of SOP. 5.3. Head of Quality Assurance is responsible for SOP approval. PRECAUTIONS 6.1 Ensure proper gowning during sampling (i.e. garments, gloves & mask). 6.2. Disinfect the sampling kit/ utensils before sampling with 70% Isopropyl Alcohol. 6.2. Ensure GMP requirements for compliance during in-process sampling. PROCEDURE 7.1. General Instruction 7.1.1 The necessary precautions must be taken when a sample is collected. 7.1.2 Wash or clean the hands properly with disinfectant agents before sampling. 7.13 Keep the hands & fingers dry, never place wet fingers on drums or containers during sampling. 7.1.4 Wear dust free hand gloves, mask and head cover properly before sampling. 7.1.5 Avoid inserting fingers or other objects in the mouth or on the lid of the container during sampling. 7,6 Minimize exposure of the container to air at the time of sampling. 7.41.7 _Use cleaned & dried sampling kit or utensils for sampling. 7.1.8 Store sampling equipment in a clean, dry and well-ventilated location. 7.1.9 After sampling carefully close all containers tightly and affix the label on sampled container or poly bag properly. 7.1.10 Make a detailed record of sampling in “SAMPLING ADVICE FORM", before sampling, then transfer to Quality Control Department for analysis. 7.2: Sampling Container 7.2.1. Use clean poly bags for sampling of intermediate or bi Qu & a Ik granules, dry powder, ee | 5 - ee repared by: Checked by, ea, F yy: _| Farahid Deeb: ‘Approved by: ____— es fer cAt Md, Tubarak Hossain Deb Narayan Biswas__——! __| A Asst. Manage ——— itpAVANA STANDARD OPERATING PROCEDURE Navana Pharmaceuticals Ltd. ina Rupshi, Narayanganj, Bangladesh wo SAMPLING OF INTERMEDIATE, BULK, FINISHED & RETENTION SAMPLE ment No.) SOP/NP/QA/OAS Tue pate | October 14,2019] Revision No] _ 06 = UT TANDOIT ASTER| Isedes Tovbs, Noverber 30, 2018| Eectve pate | PTY Copy No. iment | Quality Assurance Review Date | October 13, 2022| Page3of7 | FIT Use clean & dry vial for sampling of solid sterile powder before star filling & sealing. g of filling and after 7.23. Use clean & dry bottle or beaker for sampling of bulk liquids. 7.3. Sampling Stages | 73:1 Collect the sample in intermediate stage after completion of granulation for checking of moisture content in IPQC department. 7.32. After completion of blending collect the sample for checking of appearance and moisture content of blended materials in IPC department. 7.3.3. For validation batches and label claim <5 mg of API for tablet & capsule, the blended samples shall send to Quality Control Department for analysis. 734 Blended sample for PFS and bulk sample for liquid shall Department for analysis. 7.3.5 After completion of compression ani Control Department for analysis. 7.3.6 After completion of coating, PFS & liquid filling-seal Control Department for finished product analysis. 7.3.7 For liquid product, samples will be sent to microbiological test. 7.4.8 intermediate sample are not collected for dry powder for injection, but bulk sample of dry powder for injection are collected by vial afte filling & sealing. 7.3.9 Collect bulk sample of liquid inject vessel after mixing. send to Quality Control d encapsulation samples shall send to Quality ling samples will be sent to Quality Microbiology Department separately for tion or eye drops by sampling probe from process 73.10 Collect final sample of liquid injection or eye drops after filling & sealing with filled container (e.g, ampoule, vial or plastic container). 7.3.1 After completion of all manufacturing step the Quality Assurance Personnel will collect, the retention sample during final packaging randomly. ° 7.3.42 The quantity of intermediate, bulk & finished products & Re 7 etention according to sample plan. eae aes 73.13 ‘At the time of intermediate, bulk & final samy , pling a "Sampli : Se yacieed HEN Ic beamional ts smnecire= a THe Ano dees el 73.44 fi Collect samples for sterility test of asepti ptically filled products i i ‘ \ represent the entire duration of filling & collect the last 5 ne mae aaas Product for endotoxin test. Collect samples for sterility test of terminally sterilized product fr tray of a load a ee Wa Tubal [pepo maou | Ody lanager, QA | BGM, QA_* — _| Wet Olt aesJAVANA STANDARD OPERATING PROCEDURE Navana Pharmaceuticals Ltd. “on Rupshi, Narayanganj, Bangladesh oo . SAMPLING OF INTERMEDIATE, BULK, FINISHED & RETENTION SAMPLE jent No. SOP/NP/QA/O15 Issue Date October 14, 2019) Revision No: 06 edes Rev.05, November 30, 2018| Effective Date | 01 JAN2070 Copyno. ASTER ftment Quality Assurance Review Date | October 13, 2022) Page 4 of 7 and collect samples for liquid borne particles and endoti test randomly. Generate requisition to QA department if PD department need any sample for their test purpose from first three batch of a new product or any other three consecutive validation batch for any product & QA department will give PD department the required sample. 73.16 7.3.17 If any department (i.e. QC, QA & PD) require further sample for analysis or validation and other purpose, Sample will be given to specific department as per proper justification and documentation, ‘Sample should be taken as per SAMPLE PLAN attached as annexure 12.2 herewith. Mf any New Product launches, after approval & before the next review date of this SOP, following guideline should be maintained. General Pharma 73.18 ‘Sample Quantity Retention Product orn core (Quantity of ae uu | apeleable | coated Tabet / ‘abley WorTablet | Filled capsule y ea capsule) 30s, 18's 20 | 20p 50 pes Tablet/ 2 s/a8is 208 | 20p5 Capsule | 207s/40's/s0/100's | 20¢ | 20pcs 605 208 90 pes 50 pes 96 pes 0 pes. 100,pes 20 pes SO pes 120 pes. pedate | ae | om | OORT Product Tyee Syrup | Anvpacksize | 100ml | N/A PFS Anypacksie | 35g | N/A cos [ Anvpacksie | 35¢ (03+01) ph. | 4 bottles: O2ph. 6 bottles NA (03401) pes |G bottles Cephalosporin/svPO Sample Quantity Product Type Pack size Corelt foun | sPpleble or Tabet only) 40 Ts 2 | a0 Retention oated/riteg | (Pes) (Pes) abe |223/8/205/605 |" 206 Capsule 52 40. ” 49 a |__| Prepared by: Name [Prepared by: | Check n Farahid Deeba ee Designation | Executive, GA Wi Tubal Hossain [pe narayan Sat Sign. & Date st: Manager, QA DGM,QA_ + ——— . ol ~———— 1G LOND SuptNAVANA STANDARD OPERATING PROCEDURE | Navana Pharmaceuticals Ltd. Tieteitemn Rupshi, Narayanganj, Bangladesh E: SAMPLING OF INTERMEDIATE, BULK, FINISHED & RETENTION SAMPLE ment No. SOP/NP/QA/015 Issue Date October 14, 2019] RevisionNo} 06 ASTER srsedes Rev.05, November 30, 2018| Effective Date | 01JAN 2020 Copy No. artment Quality Assurance Review Date | October 13, 2022| Page 5 of 7 ied Pea] (MB | Retention ProductType | Packsize suk | core | MAPCHIV® | Retant Eye/Ear/Nasal Any pack size SO mit ial Drops 100 mi N/A (10+5) Ph. 6 phials PFS <30ml 2g N/A 02 ph. 6 bottles PFS 30 mi 358 N/A 02 ph. S bottles PFS 50 ml/60 ml 45¢@ N/A 02 ph. S bottles PFS >60 mi 68g N/A 02 ph. 5 bottles Tnjection\V | Any packsize , (Powder) Avial N/A (148) pes 6 bottles Injection IM ‘Any pack size (Powder) lvial N/A (36 +5) pes 6 bottles Injection Any pack size er somi | n/a | (31+20)pes | 6 bottles ‘Animal Health Products Finished Product Type Pack Size Blend/Bulk | Product for Retention QCtest Bolus Any pack size 20g 20 Boli ACarton Powder 500 6 206 206, 100 g /Sachet Powder 1006 208. 20g 4 Sachet (Full) Powder Akg 20g 20g 200 g/ Sachet Liquid iuiter 200 mil 100 mi iter Liquid S liter 3100 mi 100 mi ‘Luter id 100 mi 100 mi 200 ml | i bottle (Full '¥ required sample quantity differs from above criteria and sample quantity requires to be changed as per QC requirement, sample quantity for those Products sh after discussion with DGM, QA. ahi RELATED DOCUMENTS \ NA \ 9.0 CHANGE CONTROL Head of the Department is only authorized to mal Control SOP. ke any changes in the SOP thr rough the Change x Prepared by: il —— - Designation Execu Md. Tuba 7 | Approved by: eration _| Executive, QA rak Hossain 5 Sign. & Date Deb Narayan Biswas__— Asst, Manager, ga DGM, QA toeSNAVANA STANDARD OPERATING PROCEDURE | Navana Pharmaceuticals Us, Rupshi, Narayanganj, Bangladesh pe E: SAMPLING OF INTERMEDIATE, BULK, FINISHED & RETENTION SAMPLE lument No. ‘SOP/NP/QA/O1S Issue Date October 14, 2019] Revision No} 06 - TE yersedes Rev.05, November 30, 2018 | Effective Date | O1JANZ02 | CopyNo | ooy partment. Quality Assurance Review Date October 13, 2022| Page 6 of 7 1.0. UST OF DISTRIBUTION SI] Division/Department/Section Copy | Si. jion/Department/Section | Copy No. No. _| No. No. URANCE (MASTE oi | ues ee w/a | 10 | PRODUCTION (GENERAL) 09 copy) IMAL 02 | quauity conTRoL (GENERAL) or | a1 | PROOUCTION(ANIMy 10 HEALTH) 03 | QUALITY CONTROL 2 ICILLIN) nu CEPHALOSPORIN) 02 PRODUCTION (PENICILLIN) ‘04 | QUALITY ASSURANCE (IPOC 03 IN ( SVPO) n ceneralsoutD) 13. | PRODUCTION ( SVPO) 05 | QUALITY ASSURANCE oa aa | PRODUCTION 5 _| trac GENERAL PACKING) (CEPHALOSPORIN) 06 QUALITY ASSURANCE (IPQC os [a5 auaeroanl PRODUCT DEVELOPMENT 4 07 | QUALITY ASSURANCE S | (IPQc svPo) (08 | QUALITY ASSURANCE oO” |__| (Pac ANIMAL HEALTH) 09 QUALITY ASSURANCE os (POC PENICILLIN) 1.0 CHANGE HISTORY 3, tig, |Nameof initiator | RevisionNo. | effective date | Reason for change a [WA 00 - N/A [NA on : NA 4 Bi | wenrezaman o 1710N2013 | Document Change Mehedi asan 8 29§C2014 [Document format & text change Ma. aif 04 J onsan2oig | LB change & merger with | Navana Pharmaceuticals Ltd. a c= Prepared b ea repared by: Name Farahid Deeb: Checked by 5 [oengraion Beenie! |W. Tubarak tosis J ies a ae Sign. & Date Asst. Manager, OA, Snel EDICT Se RED cTarsreerep |. NAVANA STANDARD OPERATING PROCEDURE Navana Pharmaceuticals Ud, ee Rupshi, Narayanganj, Bangladesh E: SAMPLING OF INTERMEDIATE, BULK, FINISHED & RETENTION SAMPLE ument No. | SOP/NP/QA/015 Issue Date October 14, 2019| Revision No} 06 ersedes Rev.05, November 30, 2018 | Effective Date | O1JAN2020 | Copy No. ASTER vartment Quality Assurance Review Date | October 13, 2022| Page 7 of 7 i ith 06 | Md. Kawsar Hamid 0s a6 nov 2018 | Adlon of Animal Healt! ‘Sampling Plan. Updating document, inclusion of 07. | Farahid Deeba 06 OT JANDA |73-28 Updating Annexure 12.1,12.2 & 12.3 2.0 ANNEXURE 12.1 Sampling Advice Form, Form No. F/NP/QA/030 12.2 Finished Product Retention Sample Record F/NP/QA/061_ 12.3 SAMPLE PLAN, Prepared by: mn Farahid Deeba lecked by: Executive, Oa Approved by: Deb Narayan Biswas. rered ov Wino? NAVANA, SAMPLING ADVICE FORM Navana Pharmaceuticals Ltd. Rupshi, Narayanganj, Bangladesh [enecked on, SE TyLiolr | Areroved By Baby vt-w 4/107 19] Ref SOP No.: SOP/NP/QA/015 set Name Product code | Batch No Lot Mig. Size Pack size GA Ref. No. Be. _| [0 Local 0 _Institute | O Export (Country: ) Status: 7 [Pred 0 QA 0 PDO Microbiology “Tre [a aa 0 QC _OPD 1 Microbiology BY stage: pled Qty Container No. pled By Date Time eived BY Date Time Physical &Chemical Analysis Microbial Test 1 Description D ioo/mcjwe OD Visible foreign particle [ 0 Limit Test tobe [0 entiation 0 oT D Uniformity of WT |G Bacterial Endotoxin NU} tobe | Length/oiameter Clarity 1 Content/Assay O sterility oa Hardness © Conductivity © Uniformity of content | Others vy Thickness D Dissolution Others © Avg. filled Volume/Wt. pH cm [Dered 0 GA 0 PD _O Microbiology qo [cA DOC OPO _O Mierobiolony ast stage: ampled aty Container No. ampled BY Date Time eceived BY Date Time Physical & Chemical Analysis Microbial Test 1 Description TD Lop/mcwe 0 Visible foreign particle | CLimit Test tye | Identification 0 oT © Uniformity of WT | Bacterial Endotoxin feats}to be | Length/iameter © larity © Content/Assay Osterilty performed |G Hardness 1D Conductivity Uniformity of content | 0 Others D Thickness © Dissolution Others © Ave. Filled Volume/Wt. 0 pH ‘Status: from [Oprod 0 QAO PDO) Microbiology [Te [0 GA 0 OC OPO 0 Microbiology Test stag Sampled Qty Container No. | Sampled By Date Time Received By Date Time Physical & Chemical Analysis — Microbial Text (© Description TD LOD/MC/WC Visible foreign particle | C1 Limit Test Test{s)tobe | Identification oor © Uniformity of wT | CG Bacterial Endotoxin Bertrmeg | Length/olameter © Clarity © Content/Assay Dsteriity i i 7 © Hardness 1 Conductivity © Uniformity of content | others 0 Thiekness Dissolution Others Avg. Filed Volume/wt.__O_pH _ [Pg Ferm No: FinP/aayoag evn: 03Tyo aed 6102 ‘Pt Jeqo129 :a1eg UosIAay 20:'0N uorsinay 190/¥O/aN/4 “ON wios ‘ayep waHe) (sod) oyeq 2 ubis sojdwes uaye, | aimnsuy | (Aud) (woo) | (Aud) (wo3) (ya) | (wo) | (Aud) | (utd) | ‘ON Aq poxaya, uonuayas =| AQueND e HOdKg znodxg 1 Hodey feo on usta | “S suyaegins | 10. ~adky ‘STO/VO/ANTA0S “ON OS 24 ri FON aBed "pop wonporg Tawen BnpoHd L : 7A bya CR “Ag panosddy SPAS ta pope bulor ep 48 posedora | sae HuuedueAesen ‘ysdny piovay ajdweg uoguajey Jonpodd pays|uld anaesSAMPLE PLAN Navana Pharmaceuticals Ltd, Rupshi, Narayanganj, Bangladesh GENERAL PHARMA Sample Quantity st Generic Name “Test Sample Retention | Pack Size Brand Name no.) C82 Blend | care | coated | wow) | (nos) Same | (es) | ates) Tablet 1 | TAB-36 |Alba Tablet |Albendazole USP 20g | 50 N/A 96 48's Paracetamol 8? & Tramadol ; : 20g] 20 | 50 | 100 | 20% 2. | TAB-246 |Alkafen Tablet Hydrochloride BP : 3_[ TAB-37 [Anamet 400 Tablet [Metronidazole BP 20g | 10 | 50 300__| "00s “4_| TAB-155 |Azirox 500 Tablet Azithromycin Dihydrate USP 20g | 10 SO~ 30 18's ‘5, | TAB-207 |Arokast 4 Tablet Montelukast Sodium USP. 20g | 50 N/A 120 30's 6 | TAB-327 |Arokast 4 FT Tablet __[Montelvkast Sodium USP 20g | 50 | NA 120 | 30s | 7 7 |rao.27 lavokast4 Flash abet Montelukast sodium Use noe | 20 | so | 90 | 205 | Ta-708 [wokastS Tablet [Montelukast Sodium USP ze || WA | 20 | 305 TAU-328 [ArokastS FT Tablet [Montelukast Sodium USP zoe] 20 | 50 |» 90 | 30s J 10 [16-209 [arokast 0 Tablet [Montelulast Sodium USP 20g | 20 [50 | 30 | 305 ‘11 | TAB-146 | Arolax-i Tablet |Levosalbtamol Sulphate INN 20g | 100 N/A 200 100s. ~~ 12 | TAB-145 |Arolax-2 Tablet, |Levosalbutamol Sulphate INN 20g | 100 N/A 200 100's 13 | 1a8-242 [Asurel 10 Tablet [Prasugrel ydrochloride WN | 208 | 20 | so | 100 | 20s 2 [08-243 [asuels Tablet [Prasugrel Hydrochloride WN | 20 | 20 | so | s0_| 308 [lucosamineSufate Potassium " 190-326 [Bonacerin Tabet woe | 10 | 50 | 90 | 20s es * |Chlorice USP & Diacerein BP c = Te | Taw [thence Tobit [ascorbic acid 8 2g [50 | wa | 200 | 200 17 | TAB-99 |Clonipres0.1Tablet__|Clonidire Hydrochloride USP 20g | 50 N/A 180 60's 18 [ta0-100[lonipres 0.3 Tablet” [eonis 12 HydrochiorideusP | 20e | 50 | wa | 150 | sos 35 [108-253 [Gail 5 Tablet [Tadalatuse 20g [-20-[ 50 | 100 |_#s 20 TA8-260 [cil 10 Tabled [Toda TSP 206 [-20| so] 100 | as 21 | TAs-267 |Ciafil 20 Tablet [Tadala:il USP 20g | 20 ET 100 4's 22 | TAB-42 |Clozam Tablet |Clobazam BP 20g | 50 N/A 100 1100's 23 | 148-138 |[Cvnor-10 Tablet Jamlad pine Besylate BP 208 | 50 | N/A 220_| 30’ 24 | 1Ab-137 [Cvnors Tablet JAmiod' sine Besylate BP 208 | 100 [N/A 220 | 30's 25 | TA8-117 |cvnor-A Tablet [ariodPine Besylate BP & Atenolol | 256 | 109 | N/A 120 | 60's 26 | TaB-345 [Conpan 1 Tablet (Clonazepam US? 20¢ | 100 | N/A 120 | 30's 27 | TaB-289 [Conpan 2 Tablet [Clonecepam USP 20g | 100 | WA 320 | 305 2a | Ta8-250[conpan 05 Tablet [Clonaceram USP 20g | 100 | wa [150 | S3eF {29 [ra0-335 |Colomeb Teblet__[Mebeverine verocnondeae | 208 | 20| so] ~a00 “Tso 30 | TAS-90 |Desatrol Tablet |Desloratadine BP 20g | 20 50 100-7 31 [08722 [oiewe 5 Tablet |Piogltczone yerochorde IN| 208 | 20 | so | 90 3 | a8 223 ious 30 Tablet [Pogltezonetiyerocloride WN | 208 [20 | so] 0 33 | 1a8.336 lDitarol Tablet [cholicaleiferol USP 20 | 20 | so 720 24 [1a8305 ciple Sable [nag 206 | 2030 | 0 . ‘as-a22|cipin w soo Taner [Mellorin yeTocod@e PE aia inagiytin INN . 20@ | 10 | 50 90 awa7a [Epp 10 Ta ae 2|esjoi 100 Tablet [Sitdenadi citrate USP ze | 0 | so 100 Prepared: raraia Deaba cer Fahd Desi ereced By: a. Tobarak Hossain [Anroved By Deb Narayan away pesto: Designation: Ast. Manager,0% ” lDesinaton- ogi ax ba Sane ae: ee sen & Oates E : hn TAO Rone yi | Page LofsNavana Pharmaceuticals Ltd, Fy NANA SEAN ‘Mebane Sample Guontiy ‘Test Sample 1 GenerieName tecention | pace Code Grand Name tend | core | coated | nou) | (wos) samote | (es) |Table) 37 | TAB-268 |Enjofil 25 Tablet sildenadil Citrate USP 20¢ | 20 50 100 as +38 | TAB-266 [Enjofil 50 Tablet Sildenadil Citrate USP 20g 10 50 100 a's "39 | TAB-122 |Eryrox Tablet lErythromycin Stearate BP 206 10, 50 90 30's Naproxen BP & Esomeprazole , na 20 10 50 96. 48's 40 | TA9-247 |esona 375 / 20 Magnesium Trihydrate USP 2 o Naproren BP & Esomeprazole : 2 20, 10 50 96 48's 441 | 1a8-248 |Esona 500 / 20 |Magnesium Trihydrate USP Z Esomeprazole Magnesium , f | so | 0 | oo 42 | TAB-107 |Esotac 20 Tablet trihydrate USP 208 “43 | TAB-106 [Esotac 40 Tablet [Esomeprazole Magnesium 208 | 20 50 90 30's aa [TAb-36 [Fea Plus Tablet [Porcstamol8? &caffenos? | 20¢ | 10 | 50 | 200" | 100% 75 | ta0st [Fea Tablet Paracetamol 208 [so | wa | 200_| 200 7 [Tab213 [ea xk Tablet [Paracetamol 8P 206 [a0 | 50] 400 | 00% “7 18-4 Foxacin S00 Tablet [cprofonacia Hyrochtonaeuse | 206 | 10 | 50 | 90 | 305 7a | Ta0- [rovacin Tablet [CiprofnacinHyrochionde us| 20e| 30 | 50 | 100 | 50% 15 | Ta6-306 [Fiodox 400 Tablet _[Doxofiine WN 202 [10 | 30 | 200 | sos 50 | Tan313 Ftodox 200 Tablet _[Doxofline IN 208 | a0 | so | 90 | 20s \51 [ras.aie |FilodoxsRTablet___[Doxofylline INN 2%e | 10 | 50 100 | 50% Folie Aad USP & Pyldosine s2|rasase|rotcord Tablet verochorde BP & nog | 20 | so | 90 | a0 cyanocobalamin 3 | ran3se frocard 20/50 Tb1et [pyrosemide np spronalocwonear | 208| 20 | so | 90 | avs 54 | a0. rvcaraao/s0T=bet |posemigeor,spronouctonese | 208| 20 | so | 90 | aos 35 [Ta0a07 [Satan Tatler aufloracin Sesauhyeratewy | 20g | 20 | 80] 90 | aes 56 | 7A6-253 [Gemelon [Gemifioxacin Mesylate INN. 208 | 20 50 96 6s 37 | ¥AB-242 [Glix80 Tablet [Gicanide BP 20 | so | wa | 100 | sos 58 | TAB-288 [Joytrip Tablet lHyoscine Hydrobromide BP 20g AO | NA 150_|_30's - 100 NIA, 144 48's 35 [100 251 [migra S Tabla [Fonantine 20g | 20 | so_| ase [30s | 60 [78-292 |imigra 10Tablet_[lunarine oP 208 | 20 | 30 | 90, | 30s 61 [taoa2e fetonae 100 Tablet [Ketoprofen BP anal faon| col Wacol ane 62 [TaBi26 [etonoc so Tablet [Ketoprofen a? Sop bao toe] Taso soe 2 |ranaia hindientvanier [Caer Carbonate Ph. Grade(cora =, aoe |Cholecalciferol USP 208 | 10 50 100 50's \ Ge |rana; bunacarontoner” e2Un carbonate Ph Gradeo | hotecateferot use 20g | 10 | so so | 30s | Prepared oy Faraha beste 7 Designation: Exceutive: ene checkes By: Md. Tubarak Hossain Approved By: Deb Narayan Biswas Pesan slgaton: Asst. Manager, QA [oestgnaton: OGM GA Seton ee Satna ; tele} ty TYLOLLD Peri, wrens Page 2 of 8N Navana Pharmaceuticals Ltd. NAVANA SAMPLE PLA\ Rupshi, Narayanganj, Bangladesh TAMUMEE LAST COMPAR GENERAL PHARMA ‘Sample Quantity y Test Sample , jr Generic Name Retention | Pack Site Code Brand Name ica ce aera oc sample | (Nos) | Tablet (Nos) = | TAB-72 |Levoquin S00 Tablet _ [Levofioxacin Heminydrate USP 2e| 20 | so | 96 | 24s 56 | Tab-71 [Levoauin Tablet Levofloxacin Hemihydrate USP 20¢ | 10 | 50 100 _| 20s 57 | 1A8-189 |Lipostat 10 Tablet __ [Atorvastatin Calclum USP 20g | 20 | 50 30 |_30's 68 | 1A8-190 |Lipostat 20 Tablet__[Atorvastatin Calcium USP 20g | 20 | 50 30 |_30's 69 | TA8-47 |Lopan Tablet Hyoscine Butyl Bromide BP 20g | 20 | 50 200 | 100s IMeclaine Hydrochloride USP& 3-144 [Mec Tablet 20g | 20 | 50 100 | 50's 70 | RSA [Se Pyridoxine Hydrochloride BP é 7A | Ta8-74 [Meltix Tablet [Flupentixol HCI BP 20¢ | 30 | 50 100 | 100% 72 | TAB-A74 [Metolaz Tablet [Metolazone USP 206 | 20 | 50 90 | 30s 72 | TAa8-39 [Miracal500 Tablet |Calclum Carbonate USP 20 | 10 | 50 100 | 50% [calcium Carbonate USP & 3-120 |Micacal 0 Tablet{15's ass 74 | 108120 Maca TabIEAIS) lerniecaiterol(vtamin use | 26 | 7° | 5 a [Calcium Carbonate USP & 20 | Miracal O Tablet(20' 50 30 75 |1a0-220 |iracal Toblet0') |cpoiecalfral(vitaminoyuse_| 728 | 2° 76 | TA8-40 [Miracal Tablet (Calcium Carbonate USP 20e| 50 | NA | 100. 77 | tap140 |Miracal-m Tablet |Calcium, vitarninD & Multimineral | 20g | 30 | 50 105 [Thiamine Mononitrate USP, 78 | 118-163 [vio Tablet Pyridoxire Hydrochloride 8° & | 20 | 20 | 50 100 | 50's cyanocobalamin BP 79 | 708-230 |Myobac- 10 Tablet [Baclofen USP 20g | 100 | NA 30 | 30s 80 [18-228 |Myobac-5 Tablet |Baclofen USP 20g | 100 | WA | 120 | 30s 81 | TAB-96 |Naltrax25 Tablet [Naltrexone Hydrochloride USP 208 | 20 | 50 100 | 10s | — 82 | TAB-37 [NaltraxS0Tablet [Naltrexone Hydrochloride USP 206 | 20 | so 300 [10s 83 | TAG-271 [Nauset 8 Tablet lOndansetcon iydrochloridese | 20e | 20 | 50 90+ | 30s aa | TAB-98 |NavixTablet [clopidogrel Bisulphate USP 206 | 20 | 50 90 | 30% [clopidogrel Bisulphate USP & 85 |1A8-139|NovicPlusTablet |S np 20g | 20 | 50 30 | 30's 6 | TA0-114 |Naxo 250Tablet___[Naproven 6P 20g | 10 [so [100 | sos 87 | TAB-113 [Naxo 500Tablet [Naproxen BP 206 | 10 | 50 100 | 50's 88 | 1AG-254 [Nestor 10 [Rosuvastatin Calcium BP 20¢ | 20 | 50 100 [20° 7 89 | 1A8-255 [Nestor IRosuvastatin Calcium - 7 josuvastatin Calcium BP 208 | 20 | so 80 | 30 4 TAB-53 |Normaten Tablet [Atenolol BP 206 | 50 | wa] 100] 00" Vitamin A (Beta carotene)Ph. Grade = 91 | 148-38 |Noxid Tablet Vitamin C BP(Ascorbic Acid) & 20) bic. e| 20} so 7 vitamin Es? aoe | ae etformin Hydrochloride BP 20 33 | TaB35 [met 500 T ei © 10 | 22 met 500 Tablet [Metformin Hydrochloride BP 206 | a0 ‘94 [7a8-134 Jw-met 850 Tablet [Metformin Hyérochloride BP 20) 30 300__| 50 | e | 30 [50 100 | 50's [Prepared ty: Faranid Deeba erckad yt Towab Honan apoB OaS Newent \sst. Manager, QA Designation: DGM, QA, _ Becton: eed i Page 3 of 9A. a NAVANA SAMPLE PLAN Navana Pharmaceuticals 114, . Rupshi, Narayangan), Bangladesh GENERAL PHARMA Sample Quantity Test Sample 2 Code Brand Name Generic Name E retention | Pack Size No. stend | core | costes | “wes | (os sample | won) | rable en) 127] TAa-S4 [Spark Tablet |Sparfloxacin INN 20g | 20 50 100 10's Table |Doxylamine Succinate USP & 20 20 50 10° 28 |TAB-333 simon Tablet |Pyridoxine Hydrochloride BP 8 oe SH [zs] tase ermnranet [Asin oP me | @ | a | a00 | aos /130| TAB-277 |Tabis 2.5 Tablet |Bisoprolol Fumarate USP 20g | 30 50 150 30's 131) ra8314 rab Pus Tablet _|ssoprotol Fumarate USP aoe | 30 | so | 150 | 30s 132| TAB-278 |Tabis 5 Tablet Bisoprolol Fumarate USP 20g | 30 50 150 30's 133 | TAB-315 |Tabis Plus 5 Tablet |Blsoprolol Fumarate USP 20g | 30 50 150 30's 134] TAB-221 |Talopram 10 Tablet — |Escitalpram Oxalate USP 20g | 20 50, 90 30's — [35[ 798-220 [Tetopram S Tablet |Esctalpram Oclate USP 208 | 20 [50 | 120 | 20% [:36|ta0-224 [Teron 2 Tablet [Tolterodine Tartrate USP 208 | 30 | 30 | 150 | avs 137] TaB-126 [Toma Tablet____|ketotfen Fumarate BP 208 | 30 | 50 | 200 | a00's 138 [118354 frorcox60 Tablet [toriocib NN 202 | 20 | so | 90 | aos 139 | 1A8.353 [Toreox90Tablet __|toriocio NN 208] 20 | so | 90. | aoe 14i| 100-65 [Train Tablet cetiine oinydrochiondesP | 208 | 20 | so | 100 | 200s {242 TaB-214 [Tynaxie Tablet Bromazezam BP. 20e | 50 | N/A 90 30's [43 [ 148-175 |Urinide Tablet Bumetanide oP 208 | 100 |N/A 100 | 20's 14a) tae 232 [Urinidess Tablet __[aumetaniée oP 20¢ [30 | so | 120 | aos 125 | Tat-363 Vaspee WR Tablet [Trimeteidine yerochiondea? | 20e | so | s0_| 90 | 30's 146| TA8-70 [vomitop Tablet Domperdone Maleate BP 20g | 20 | so | 00 | 100 147) TAB-88 |Xanax-0.25 Tablet |Alprazolam USP 20g | 100 N/A 200 1100's asl TaB-a9"[xonacoS0 Tablet [Alprazolam USP 206 | 100 | WA | 150] sos 149| Tab-t21 [zerodoiTablet Aceclofenae OF 202 [20 | so | 100] sos Capsule ~ Sample Gua si ext Sample No.| 28° Brand Name Generic Name att ner - wens | cow | cnn | “ern | Psksie sama | en) | “Ho 1 |CaP-250|Clincin 300 Capsule —_|Clindamycin Hydrochloride BP 208 | N/A 50, 90 30's [2 |car-209]cincin 150 capsule [ctindamycin Hydrochloride 8° | 208 | WA| 50 po] 30: | [checked by: td, Tubarak Hossain [Approved By: bcb Narayan biwas Designation: Asst. Manager, QA Designation: DGM, QA a: |Sign & Date: sign & Date: | 4 re Tite ® Vor unas Page 5 of 97 ‘= NAVANA SAMPLE PLAN A‘ home Pharmaceuticsls Ltd, ; \upshi, Narayangan), Bangladesh anv LATCH MEN GENERAL PHARMA i —_——— ‘Sample Quantity | Test Sample S\| code | rand Name Generic Name wow | cow Tome] etn | reste No. paul | wos) | (Nos) sample | (Nos) | (vos) J [capcoi [DinacTACapsule [Diclofenac Sodium 8P 20g [wa] 50 300 — | 1005 + [car-375 [Dextac 30 Cepsule_[Dexlansoprazole INN wa | N/a | 50 30, | 30's J [car-376 [Destac 60 Capsule __[Dexlansoprazole INN wa [wa | 50 a20__|_24's [Esomeprazole Magnesium onl eee = 5 |car-295 lesotac 20 capsule Srrnvdrate USP ya | wy 120 s [Esomeprazole Magnesium 7 | cap-296 |esotac40 capsule — |rrinydrate USP wa | wal 50 90 | 30s [Dried Ferrous Sulfate USP & Folic ; ul nia | w/a] 50 120 | 60's 8 | CAP-02 |Fef TR Capsule acid USP Vt 9 | caP-110 |Flubiotic 250 capsule |Flucloxacilin Sodium BP 20g | WA] so | 100 | 205 30 | cap-t11 |Flubiotic $00 Capsule |Fluctoxacillin Sodium BP 20g | N/A| 50 a2 | 28 11 |caP-203 |Imigra 10 Capsule _[Flunarizine Hydrochloride OP 20g | WA| 50 150 | 30's 12 | car-94 |imigra Capsule Flunarizine Hydrochloride BP 208 | WA |__59 1ca_|_ 50's 73 | car-é9 [Itracon Capsule leraconazolePh.Grade nia_[ w/a [50 v6 | 24's 14 | CAP-03 |tucon 150 Capsule _|Fluconazol USP 20g | N/A 50 100 10's 15 | caP-0f |Lucon 50 Capsule |Fluconazol USP 20¢ | NWA| 50 oc __| 30s 36 | caP-07 |NavacloxCapsule _|Cloxacilin Sodium BP 20e | N/A| 50 300__| 10's 17| cap-aa |Navamox 250 Capsule |Amoxycilin Tihydrate UP zoe | N/A| 50 100 | 00's 18 | car-10 |Navamox500 Capsule JAmoxycilin Trihydrate BF 20g | wal} so ao | sos 9 | caP-A2 [Norn 10 Capsule _\Nortriptyine Hydrochloride a | 20g | N/A| 50 200 | 1200's 20 | caP-13 |Nortin25 Capsule [Nortriptyline Hydrochloride ae | 20e | N/A| 50 100 | 10's 21 | cap-148 lometac 40 Capsule _ Omeprazole Ph. Grade wa | wal so 96 24's 22 | cap-ta [ometac 20 Capsule [Omeprazole Ph. Grade wa | nia | so 300 | 100s 23 | cxP-132 [Opidol 100 Capsule [Tramadol HCl BP 208 | WA] 50 300 | 20% 24 \cxr-a3i [opidolS0 Capsule [Tramadol HCI BP 20¢ | NA| 50 90 | 30's 25 |cap-295|pregan SOCapsule [Pregabalin NN 20¢ | n/a] 50 90 | 30s 2 orn Pregan 75Capsvle__[Pregabalin INN 202 | Na | 50 comma Gos 210 |Rabetac 20 Capsule _|Rabeprazole Sodium INN 20g | N/A] 50 120, | 60's \ 28 | car-1ss |pregnid Capsule [o2"bonvllron, Folie acid, Zine, lAscorbic acid & B Complex NIA | N/A 50 126 42's 23 | cap-258|Urotam capsule _[Tamsulosin Hydrochloride Ph. = Grade wal wal so so | 305 x cw 283) ares Capsule \Vtamin€, Vitamin Zinc, Copper -|: Lutein wa | wal r00 moles [Checked By: Md. Tubarak Hossain beet 5 [Approved a |Pesignation: Asst. Manager, 'v: Deb Narayan Biswas Sien & Date: = Peseration- om, aa ees Pe ein Yo aSAMPLE PLAN ‘Navana Pharmaceuticals 16, Rupshi, Narayanganj, Bangladesh GENERAL PHARMA ‘Sample Quantity ) Test Sample S' 1 code Brand Name Generic Name retention | Packsie . re ee are see | non | “to acd Feros Sete USP dine 31 | cap-17 |Zifef TR Capsule sulfate Monohydrate USP & Folic N/A | N/A 50 90 30's eid USP Liquid ae Sample Quantity, s Ten Semele | Ei] code | Brandame Generic Name aca] retention | sce i Bulk (MiB+Qc) (Nos) | fn 1 Paar Pare SPeIon th eevondzlebernste ? com | o2o1 | otnh. | otph. 2 | U10-147 |Arolax Syrup 100m |Levosalbutamol Sulphate INN. 100 ml 03+01, 04ph. Oiph. 3 | U10-182 |Arolax Syrup 60m! jLevosalbutamol Sulphate INN 60m 03+01 ‘O4ph. | O1ph. 4 | osp-218 |Azirox FS (20 ml) Azithromycin Oihydrate USP 348 02 ‘osph. | o1ph. = [oars [aaron PFS (95 mi) [arthromyin Dhydrate USP wee | oh ah © [p25 [paroxPFSSOmI —[aathromyeln USP a 7 | onp-287 [prox Paediawi OroPy |Ambroxol Hydrochloride BP 30m 0301 | o4ph. | Oph. = Paar fe sam i0o mt brave Ryerocionde oP Fe A + onr-ae |atonnl rop, 25 mi [simihcone USP smi conor | oaph.— | o1ph a [205 [ehewee Syrup 60 mi_[Ascorbie Aca BP com onvor | baph. | O1pn. 11| u201 [enewce syrup 200 mi [Ascorbic Acid BP oomi} opvon | apn. | oxpn. 12 | U1a-206 |chewce Syrup 200 mi Ascorbic Acid BP 200 mi 03401 O4ph. Olph. 7p | uav2es [pesatot syrup 60 mi [Desoratadine USP comt | oxo | apn. | otph 14 | osP-123 oa Dry Syrup, 100 Jervehromycin Stearate BP 116 02 o4ph. | o1ph. 7s | 11030 eo suspension 60 i [Paracetamol oP com | oxox | oan. | oxph, xual For 16 | prs2sa voor Hyarochoide USP . S- guspension \Ciprofloxacin Hydrochloride 308 03+01, O6ph. Olph. een Sop, , 17 [ospana [fubiowe Ov Syrp, _ucoxacitinSosium BP 1308 ‘ozph, | o6ph. | Oiph , orassom Cate BP & Gc Aad 18 | L1Q-385 |Kcit Oral Solution Monohydrate BP 200 mi 03+01, O4ph, | 01 ph. [taxol Solution 100 mt _|Lactulose 6720? 100m! 03-01 | oaph. | oiph. 18 | ua-80 [Laxoisotution 200 mi_ [Lactulose 67960 200mi | 03-01 | Oaph, | Oph. icles ces sori acsiora] woven Toh rear Fah esa checked By: a Tubarak Hossain [Approved by: Deb Narayan Bawa peseniton: Designation: Asst. Manager, QA Designation: OGM, QA oe Tren faleny RenreGavvery Page 7 of 9="2 NAVANA SAMPLE PLAN Navana Pharmaceuticals Ltd As hchorcontanss Rupshi, Narayangan|, Bangladest ™ GENERAL PHARMA T Sample Quantity st! Test Sample | Code Brand Name Generle Name ‘al Retention | ack sue No. ‘uk masacy | (Nos) (os) 20 | 10-279 [Nauset Syrup, 50mi__ [Ondansetron Hydrochloride BP 50 mi 03401 | o4ph. | Oph. INavaclox Ory 5. tox jum Bi 130 02 | o6ph. | o1ph. 21 | 0sp-22 [en 00m! |cloxacitin Sodium BP 8 I 22 | DRP-19 |Navamox Drop, 15 ml |Amoxycillin Trlhydrate BP ve 03401 | o4ph. | O2ph. INavamox Ory . jr n6 02 | 06ph. | o1ph. 23 | 057-24 oor oom JAmoxyeilin Trihydrate BP 8 i o Navatrim [Suiphamethoxazole PE . 60 mi 03401 | oaph. | O1ph. 24 | UA3t suspension,G0ml [Trimethoprim BP " ” 2s | ua-24a cater Suspension 59} oxofenadine HCI USP 50 ml 03401 | oaph. | orph. 26 | Ua.77 orazine syrup 100m! [zine Sulphate USP 100m! | 03+01 | o4ph. | o1ph. 27 | u1G-i86 [Orazine Syrup SOmi [zine sulphate Monohydrate USP 50 mi o3e01_|_o4ph. | Oiph. 28 | a-a4r Jorazine-B Syrup 100 mi iron, Vitamin & Comlex & Zinc room! | 03401 | o4ph. | o2ph. 29 | ua.as1 Jorazine-8 Syrup $0 mi iron, Vitamin 8 Comlex & Zine 50 mi o3+01 | oaph. | oxph, 30 | 0-317 [Patrol syrup Rupatadine Fumarate INN 100m! | 03+01 | o4ph. | orph. 30 | 10-32 [Ptacent 8 Syrup 100 m! |Vitamin & Complex room! | 03801 | o4ph. | oxph. y| 31 | Ua-33 [Ptacent 8 Syrup 200 ml [Vitamin 8 Complex 200m | o3e01 | o4ph. | oxph. 32 [ucsa1_ [pintus syrup [autamirate Citrate INN 200m! | o3+01 | oaph. | o1ph lDextromethorphan Hydrobromide 33 |ua-s4a2 Jpires 0 syrup 1BP, Levomenthol BP, 300m! | o3+01 | oaph. | orph. Diphenhydramine Hydrochloride BP |Gualfenesin BP, Levomenthol BP, 34 |uucs2n [pres m syrup Dehermdcaminerydrochirdeap| 202M! | 0301 | O4ph. | Oph. [Revam Kids Syrup 100 [Coder oil, vitamin 8- Complex & 35 | ua m uacass | Rainateniee 100m! | o3e01 | o4ph. | orph. [Revam Kids Syrup 50 _|Cod lver oil, Vitamin 8- Complex & 36 | uaass . |r Multivitamins EI eee 37 | 05°-86 |r Ory syrup, 50 mt |Roxithromycin BP 286 oz | ospr. | oaph. 38 | waase [Spataxsyrup [Picycloverine Hydrochloride BP sOmi | 03401 | oapn. | o1ph. [29 | wa-r2s [Toma syrup 100m! |Ketotifen Fumarate OP room! | a3-01 | oaph. | oiph. Prepared By: Farahid be creed: Farah Deets [Checked By: Md. Tubarak Hossain [Approved By: Deb Narayan Biswas Sena One oA Designation: Peseaton: aan. Marager, Qk [ossunation:OGM.OR ian & Date =e sign & Date: 19/10/19 ION meee RBar over ty Page 8 of 9NAVANA SAMPLE PLAN Navana Pharmaceuticals Ltd Rupshi, Narayanganj, Bangladest GENERAL PHARMA eee eae T Sample Quantity 7 senere Test Sample S| cose | srananame eneric Name | san | ak — | erarac | ee fe 40 | uc-i87 |Toma Syrup Som! _|etotlfen Fumarate BP 50 mi 03401 | o4ph. | Otph. Gusiphenesin 8, Trprolidine 41) ua3é |tridexsyrup, 100m! [Hydrochloride BP, Pseudoephedrine 100ml | 03401 | o4ph. | Otph |Hydrochioride BP ‘2 | uaas |triain Syrup, 60m! —_|Cetirizine Dihydrochloride BP 60 mi 03401 | oaph. | oiph 3 | DRP-200 |Vomitop Drop-1Sml__|Domperidone Maleate BP 30 mi 03401 | O4ph. | O1ph. Womitop Suspension, 44) UQ76 he oP Pension, 60], mperidone Maleate BP 60ml 03+01 O4ph. Olph. 1s [uas20 |rlodoxsyup Doxoyline wn room | 0301 | O4ph. | Otph Cream & Ointment Sample Quantity s TexSomple code | Brand Name Generic Name SEE reenton No. sux | ameracr | 9 ‘won Miconazole Wrate 301 |vicofun HC cream sor | 06 | 308m 1 |c06-201 |Micofun-He Crear |8P, Hydrocortisone Acetate BP aoe _ C 206 petamethason Valera BP & 300 [stebet-t crea 35 ror | 06 sm 2 |coc-300|steber-ctcream —[eetometnason e | a 06 | 0% Cobetase Proplonate BP,Neomycin 299 |steco NN Cream 35 + m 3 |c06-289 [stecto nn cream a etn oP | oor | os | 156 |Econazole Nitrate BP,Triamcinolone “| 302 |stenide ce 35 . m 4 |coc.a02|stenide cream —_(econrone | osor | 05 | 1208 5 [c0c-303[steson cream Clobetasone autyrate 8° 356 | omar | 06 | 205m © |eoe25 [nate cream, 105 |Naftiine Hydrochloride US ase | oso | os | 106m 7 |coea0a [piroban ointment |Mupirocinuse 358 | oso | 06 | 205m & |coo-a37 |natga rear, 308 _|Naftine Hydrochloride USP 358 | oso | 06 | 305m 9 |coc-38 [steco cream cabetasol Proplonate a? 356 | carat | 06 | 109m 10 |coeaes [persab cream, 308 [Permethrin 8? 358 | csror | 06 | 30¢m 11 |cos acoder cream Luiconazote WN ae | omar | 06 | 106m 32 |co6-366 [lutider Cream [tuliconazole INN 356 03401 06 [30m Prepare (res aroha beste [Checked By: Md. Tubarak Hossain [Approved By: Deb Narayan Biswas ation Executive, GA Designation: hast Manager. QA [Desgnation: OGM, CA scree ianation: Ast Manager, . : hob Sentone eC Sere eG, Vao/ Type (1 hj top Ly Page 9 of 9Navana Pharmaceuticals Ltd, “j* NAVANA SAE esVPO Rupshi, Narayangani, Bangladesh tate Ma COM CEPHALOSPORIN# Sample Quantity Test Sample tion | Pack te LNo.| code | Brand Name Generic Name ET aed heerion) as sarple_| (wos) | (os) Tablet 1 frav.aze [Pureee!200—|cefnime teinyaratew | 206 | 40 | 40 | 52 12's lrablet 2 |rasazz JPuracef400—cerixime trihydrate sr | 20g | 40 | 40 | 52 | 22 3 [rae-cr — |Fixcef 250 Tablet [cefuroxime Axctil BP 20g | 40 | 40 | 52 | 14's 4 |raa-cz —|rixcet Soo Tablet [Cefuroxime Axctil BP 20g | 40 | 40 | 2 | a's fFixcef Plus 250 [Cefuroxime Axctil BP & : 5. ao | 40 | 52 | a's 5 [8437 Trabiet [Clavutanic Acid BP oe Fixcef Plus500 [Cefuroxime Axetl BP & , 1 og | 40 | ao | 49 | 7s e338 lrablet clavulanic Acid BP od Capsule Sample Qua sinvo.| code | Brand Name GenerleName Test Same retention | rack ste wend | care | copmite | “ony” | yosy sample_| twos) | (wos) 1 leapas [ceteares00_[Cetedroxttmononydrate| 505 | nya | aoncs | so | a's capsule usp 2 |car-og _|Duracef-200 |Cefixime Trihydrate BP 20g N/A | 40Pcs 52 22's fcap-si_|Duracef-400__[cefixime trinyarate6P | 20g | N/A | A0Pcs | s2_| a2's INavacef250 |Cefacior Monohydrate - fi 4 [ears [Caveule Kc 20g | wA | aorcs| 2 | 24's INavacef-500 |cefacior Monohydrate , 2 N/A 7 5 |cwr-os [eo sale ee og | N/A | aorcs | 52 | 24's © leary [Novalenn250— cefatodnatononvarate | 35, Tava | aopes| 52 | eos capsule BP iavalexin- exin Monohydrate 7 lcapon _(Navalenin-s00 | cefatexin Monohy eat linal faovesll Warnes capsule BP 8 foman feo cefdinir USP 20g | w/a | aopes| 2 | 22s [cefpodoxime Proxetih 9 |car.o7 — |sefox capsule 100 |e 20g | N/A | 40Pcs | 52 ns 10 |cap.o3 — |setto 250 capsule |cefradine BP 20g | wn | aorcs| s2 | 2s 11 |car-oa — |sefro-s00 capsule [cefradine OP 20g | wa | aorcs| s2 | 24's 12 ear-oe frencetcapsuie _[Ceftbuten Divdrate 20g | nya | aores| 52 | 7s [Checked By: Md. Tubarak Hossain [Approved By: Deb Narayan Biswas Designation: Ast Manager,0A.”[oesgnation? OGM, GA Sign & Date: =e Sign & Date: o ull RonenNavana Pharmaceuticals Ltd, NA SAMPLE PLAN a x NAVANA Rupshi, Narayanganj, Bangladesh Fy reso CEPHALOSPORINESVPO ‘Sample Quantity LNo.| Code | Brand Name Generle Name Test Sample retention | ose size Blenasomple [rs (Nos)] os) \Cefcare Paediatric |Cefadroxil Monohydrate o f 205 2 Pes 06 Axis ae pee [Drop 15 ml USP ao > losp-ag _ [Ceteare PFS 100 |CefadroxiI Monohydrate 68 pean liecste ites it use 3° |PFS-18 |Duracef PFS 30 ml |Cefixime Trihydrate BP 35g 2Pcs 0s ixi's 4 |PFS-17 |Duracef PFS SO mi |Cefixime Trihydrate BP 45g 2 Pes 0s ixi's 5 |DSP-90 Duracef DS PFS 50 |Cefixime Trihydrate BP 45g 2 Pcs 0S ixt's 6 |ORP-126 Duracef Pediatrie \Cefixime Trihydrate BP 208, 2Pcs 06 ixi's Drops 21 mi 7. |pFS-53—|Fixcef PFS 70.mi_|Cefuroxime Axetll OP 68g apes | 05 | ixt’s 3 lprsa2 [NavacetPFS100 |cefaclor Monohydrate 6a ' Ns Ha e arcs | 05 | axs's 9 pests |navacer Ps eo mi | easier Monohydrate 458 2ecs | 05 | axa's Navacef Pediatric Cefaclor Monohydrate R21 20 : 10 |ore-20 [hve a 8 2rcs | 06 | at's in PFS 300 |cefalexin xa [psean [avon PFS 00 [etx Mono eB ail ercen neat 12 [osp-43__|ricicer PFS 60 mi_[Cefdinir use a5¢ 2ees | 0s | axrs 13 |prsas —|setoxprsso mi [efpedorime Prove 458 2pes | 05 | axi's 14 Jprs.an__ [FEF OSPF 200 | cofratine uP 68g 2ees | 0s | axi's EN 15 |onpas —[Sefro Pediatric |cefragine BP 208 2pcs | 06 | axt's Drop 35 mi 16 |prs-10 —|sefro prs 100ml |cefradine BP 68 2ecs | 05 | axi's PFI ‘Sample Quantity Test Sample sto.) code | Brand Name Generic Name Sea eto saan) Mem |e ‘samy fac) | (re) (Nos) vos) | wos) Icefton tg , ; ; Inecton vjna i Ceaztime terte use | avr | 05 | ax | os | axss Cefzon 250 me , Wi ap ceftaridimosterteuse | ivi | 0s | a1 | 06 | axr's cetzon S00 me Ceftazidime Sterile usp | ivial | 05 | 31 06 | axis [Checked By: Md. Tubarak Hossain [Approved By: Deb Narayan Biswas, ! Designation: Asst. Manager, QA GM, QA sign & Date: : ign & Date eT sto $BraradisonyTANCK RAM CTIMPASY “> NAVANA SAMPLE PLAN Navana Pharmaceuticals Ltd. Rupshi, Narayanganj, Bangladesh CEPHALOSPORIN+SVPO ‘Sample Quantity Test Sample No.| Code Brand Name Generic Name injection] injection | Retention | p4cy sing Bien’ {cacy | (wey | (os) | samole | Won | ines) a | ins-t23. |Esotac v injection Esomeprazole INN wa | wal wa | o6 | 1x2’s 5 | ann2a [FeCEFLSOBIVIM | cotyroxime Sodium ap | ivial | 05 | 32 | 06 | 1x1's injection 6 | ase [Fcef250mEV |cotyroximesodiumar | ivial | 05 | 31 | 06 | 1x1’ IM Injection 7 | insae [FreeF75OME — [cefuroxime Sodiumar | ivial | 05 | 31 | 06 | 1x1's VAM Injection @ | ware fintantiniecion lryarocortsone use | tial | os | 32 | 06 | tx2s 9 | ineraa [len 500MB IV NNreropenem USP tvial | 05 | 32 | 06 | ax1's injection 10 | invaz0 [9PeM2E'V- —Iryeropenem use ava | os | 31 | 06 | axy's Injection a1 | insaas [Ometaclv lomeprazole BP wa | wal na | 06 | ax1's Injection f 12 | nar ffetrotelnlestion|cefradine sterile BP avat | 05 ) 31 | 06 | ax1's 13 |_nvar_ [Bro einen cetradine stories avid | os | 31 | 06 | axis 14 | insso [Set500 BI" Lcefradine sterile BP aviat | os | 32 | 06 | ax1's as | nao [S450 ™EIM) |cephrinesteriear | rvel | os | 36 | 06 | axr's we | ina |ToReet250meIV |ceftriaxone Sodium eee Injection sterile BP Fropcef 250 me IM [Ceftriaxone Sodium a7 | ww avial | o : 422 injection sterile BP fol | Oe | som ce | we | wags [Topcef 500 meV [Ceftriaxone Sodium tw bo lon low lists Injection Sterile FTopcef 500 me IM [Ceftriaxone Sodium 19 | wa 1 vial : Injection Sterile BP CoS es Topcef 1giV _|ceftriaxone Sodium 20 | nas 1 vial : injection Sterile BP | RSF esae | cea |e Nopcef 1 gM |Ceftriaxone Sodium a | nie a " Injection Sterile BP eel | ect ee 22 HTopcet 2 Ceftriaxone Sodium 2 | mar : injection 1v Serle BP Pace | ne | 2 line7any [TOPcel Lg vet [Ceftriaxone Sodlum - os once ne aval | 05 | a: | 06 | axis 24 | n-aayany [TOPCeF 2 vet [Ceftriaxone Sodium 0 | negtion Eats aval | 05 | a1 | 06 [ans Wess eieaton: Farahid Deeba Executive, A tanerty |Checked By: Md, Tubarak Hossain JDesignation: Asst. Manager, QA \Sign & Date: |Sign & Date Pera eto “bina wry |Approved By: Deb Narayan Biswas Designation: DGM, QAMPLE PLAN Navana Pharmaceuticals Ltd NAVANA ee rups,Naryangan argos y wweniemateowrmss CEPHALOSPORIN+SVPO Injection (Liquid) ‘Sample Quantity Test Sample No.| Code | Brand Name Generic Name injection] Injection | Retention | 9,4 5. uteSample| (ac) | «ey | (Nos) {Nos)_| _(Nos) }C-Flo 100 Injection|Ciprofloxacin Lactate /SOml +100) 1 2 {nascar [Fop0 P00 inlecton| tier meaco) on | 22 | 04 | axt's ~-Flo Injecti |Ciprofic Lactate /5Oml +100) 0 2 [avannay [ERPIION [rcfoacntac veroel oa | az | oe faxes NK 50m! +300 ; 3 |in-99(aH) aReeeen Ketoprofen 8P wmis00) os | at | 20 | axt's inw- |Ketonac vet Omi +200] : n 04 Axis 4 [any _[escten ora tomrtenar nfo | 2 x 5 liwae [Lidocaine i% Lidocaine Hydrochloride [somisi00] - | 6 a injection 2mmi__ [ae ml Lidocaine 1% |Lidocalne Hydrochloride |5Om! +100} 8 ISS Hiniection 3.50 mt_|aP m | | 3 | 7 7 liniag [soeainer% ——|UdocaineHydrochiaride [Somisa00] oo [3 fog | lInjection 7 mi BP mi |Thiamine Hydrochloride vection ayn? * Pyridoxine 50m «100| 8 jin - Mylc | «S's 4) -91 lylo Injection 3m! Hydrochloride BP'+ mi 10 31 20 2xS's Cyanocobalamine BP (Ondansetron 1 9 lind -85 |Nauset Injection {Hydrochloride Dihydrate ee 06 31 20 1xs's ap INavamectin 50mt 00 20 nw Iw ° 06 : INJ-92 Injection (vet) yermectin BF ml 31 20 ixt's ino-aza [cyanocobatamine BP + |S0mi+100 - ua tan |Navasol 100 ml lButaphosphan INN mi o1 22 04 Axt's ICyanocobalamine BP + [50m| +100] 22 |rus6 ot y (2H) aveso130 m1 oe ve 2 | os faxes 13 [ure [PRO THREION etre rrometamine|OmI HOA] 30 Tes 5 Laxre 14 jin -75 JOrc 60 Injection 2 |Ketorolac Tromethamine| SOml +100} 15 36 25 axis Im USP mi 11-98 [Paniuminj 2m |Memonium Methyl {50ml+300) 45) 3 2 | 1xs's |sulfate INN. mM Phenirav 4 [N86 (any fheniraVet Toheniramine Maleate BP|°°™ 2) os | ar | 20 | axa’s +. linjection 10 mi mi I phenira Vet Som +700 Inicton com (Phesiamine waleate ar} °°!) ox | 22 | oa | tx1's Promocal Somi +200 ; Injection a mt —_Cakitriol USP mre! 20 | sa | so | axt's (Checked By: Md. Tubarak Hossain Approved By: Deb Narayan Biswas \sst. Manager, QA. GM, QA Sign & Date: : Tay ty SP uetiy DO yy