Ds.prz.0065 - Glimepirid 4mg Tbl.- Srp.eng.- V.3.0

1

Dosije o proizvodnji serije Master Batch manufacturing record

Naziv/Name:Glimepirid 4mg tableteGlimepiride 4mg tablets

Oznaka/verzija/Number/Version:DS.CIR.0/3.0ifra meuproizvoda/Code of intermediate:81928Serija/Batch:

Pripremio-la/Prepared by:Potpis/Signature: Datum/Date:

Lansirao-la/Launched by:Potpis/Signature: Datum/Date:

Oznaka /Verzija:Number/Version:DS.CIR.0/3.0Naziv/ Name:Glimepirid 4mg tableteGlimepiride 4mg tablets

ifra meuproizvoda/Code of intermediate:81928Serija/ Batch:

Lansirao-la/ Launched by:

Datum/Date:

Zdravlje LeskovacSrbija/Serbia

Ime/Funkcija/ Name/Function

Datum/ Date

Potpis/ Signature

Pregledao/Reviewed by:T. Cvetkovi/direktor Sektora proizvodnjeT. Cvetkovi/ Production director

D. Sojevi/koordinator kvalitetaD. Sojevi/ Quality co-ordinator

Odobrio/Approved by:S. Tvrdorijeka/direktor Sektora kvalitetaS. Tvrdorijeka/ Quality director

I. PROIZVOAKA FORMULA/MANUFACTURING FORMULA

SASTAV JEDNE SERIJE/BATCH COMPOSITION: 1 000 000 tableta/1 000 000 tablets 180,0 kg Glimepirid 4mg granulat/ 180,0 kg Glimepiride 4mg granulate

ifra granulata/Code of granulate: 81924

ifra/CodeSastav 1 tbl.,mg/Weightper tabl.,mgPolazni materijali, Naziv/ Name of ingredientsStandard/StandardKontrolni broj/Control no.Verifikovao kon.broj (inicijali)/Control no. verified by (initials)Koliina po seriji, kg/Weight per batch, kg

teorijski/theoreticalstvarna/actual

AKTIVNA SUPSTANCA/ ACTIVE SUBSTANCE:

709504,00Glimepirid, mikronizirani /Glimepiride, micronisedInterna specif./In house standard............................4,00

PUNIOCI U FAZI GRANULACIJE/EXCIPIENTS WHICH ARE TO BE USED DURING GRANULATION:

70944138,00Laktoza, monohidrat 350/Lactose monohydrate 350Ph.Eur.............................138,0

709461,80Pigment prah PB-20978, plavi/Pigment blend PB-20978, blueInterna specif./In house standard............................1,80

7095425,0Mikrokristalna celuloza PH 101/Microcrystalline Cellulose Type 101Ph.Eur.............................25,0

709512,00Povidon K 30 / Povidone K 30Ph.Eur.............................2,00

709538,00Natrijum skrob glikolat, tip A/Sodium starch glycolate, Type APh.Eur.............................8,00

81778N/A1Preiena voda / Purified waterPh.Eur.............................34,2

Prorauni/Calculation:Napomena/Note:1Isparljiva materija koja se uklanja tokom proizvodnje/ Volatile substance, evaporates during manufacture

Kontrolisao/Controlled by:....................... ..................... ................ ...................... ................... ..............(ime i prezime/name) (potpis/signature) (datum/date) (ime i prezime/name) (potpis/signature) (datum/date)


SASTAV JEDNE SERIJE/BATCH COMPOSITION: 1 000 000 tableta/1 000 000 tablets180,0 kg Glimepirid 4mg granulat/ 180,0 kg Glimepiride 4mg granulate

ifra granulata/Code of granulate: 81924

ifra/CodeSastav 1 tbl.,mg/Weightper tabl.,mgPolazni materijali, Naziv/ Name of ingredientsStandard/StandardKontrolni broj/Control no.Verifikovao kon.broj (inicijali)/Control no. verified by (initialsKoliina po seriji, kg/Weight per batch, kg


PUNIOCI KOJI SE DODAJU U FAZI HOMOGENIZACIJE/EXCIPIENTS WHICH ARE TO BE USED DURING BLENDING:

709521,20Magnezijum stearat/Magnesium stearatePh.Eur.............................1,20

Prorauni/Calculation:Napomena/Note:

Kontrolisao/Controlled by: ....................... ..................... ................ ...................... ................... ...............(ime i prezime/name) (potpis/signature) (datum/date) (ime i prezime/name) (potpis/signature) (datum/date)


SASTAV JEDNE SERIJE/BATCH COMPOSITION: 1 000 000 tableta/1 000 000 tablets180,0 kg Glimepirid 4mg tablete /180,0 kg Glimepiride 4mg tablets

ifra tableta/Code of tablets: 81928

ifra/CodeSastav 1 tbl.,mg/Weightper tabl.,mgPolazni materijali, Naziv/ Name of ingredientsStandard/StandardKontrolni broj/Control no.Verifikovaokon.broj(inicijali)/Control no. verified by (initials)Koliina po seriji, kg/Weight per batch, kg


TABLETIRANJE/COMPRESSION:

81924180,00Glimepirid 4mg granulat/Glimepiride 4mg granulateInterna specif./In house standard..............180,0

Prorauni/Calculation:Napomena/Note:

Kontrolisao/Controlled by: ....................... ..................... ................ ...................... ................... ...............(ime i prezime/name) (potpis/signature) (datum/date) (ime i prezime/name) (potpis/signature) (datum/date)

II. TEHNOLOKI POSTUPAK/TECHNOLOGICAL PROCESS

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 TABLETA/ DISPENSING OF RAW MATERIALS FOR 1 000 000 TABLETS

Mere zatite/Safety precautions:

- U toku rada nositi zatitnu masku, rukavice i naoare./ Wear prevention mask, glasses and gloves.

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 TABLETA/ DISPENSING OF RAW MATERIALS FOR 1 000 000 TABLETSPoetak faze/Start of dispensing:

Datum/Date:Vreme/Time:Potpis/Signature:

FAZA ODMERAVANJA SIROVINA/DISPENSING OF RAW MATERIALS

1.1 Priprema/Checking Izvrio/Proverio/Performed/Checked by:

1.1.1 Proveri/Check: - Prisustvo listi o raienosti linije/ Line clearance checklist

............/............

1.1.2 Proveri status opreme za odmeravanje/Check equipment status for dispensing:

Oprema/EquipmentInv.br./SystemI.D.NoDnevnici/zapisi/datum/Logbooks No/dateIzvrio/Proverio/ Performed/Checked by:

Digitalne vage do 30kg Weighing balance up to 30kg13635............/............

Digitalne vage do 300/600kg Weighing balance up to 300/600kg13636............/............

Komore za odmeravanjeDispensing booth14605............/............

1Crpke za odmeravanje Scoops for dispensing......................................................................................................................................................................................................................................................................../............

1Kontejnerii/Containers for dispensed material............/............

1ostalo/other:

1ostalo/other:

1Runo upisivanje inventarnih brojeva ureaja/System I.D.No of equipment will be written manually

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 TABLETA/ DISPENSING OF RAW MATERIALS FOR 1 000 000 TABLETS1.1.3 OZNAKE STATUSA PROSTORIJE I OPREME/ STATUS LABELS FOR EQUIPMENT AND DISPENSING BOOTH

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 TABLETA/ DISPENSING OF RAW MATERIALS FOR 1 000 000 TABLETS1.1.3 OZNAKE STATUSA PROSTORIJE I OPREME/ STATUS LABELS FOR EQUIPMENT AND DISPENSING BOOTH(continued)

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 TABLETA/ DISPENSING OF RAW MATERIALS FOR 1 000 000 TABLETS

1.2 Odmeravanje i prosejavanje/Dispensing and seavingIzvrio/Proverio/ Performed/Checked by:

1.2.1 Priloi oznaku statusa za svaki kontrolni broj i zalepi na strani ili poleini Oznake statusa sirovina u Dosijeu o proizvodnji serije./Affix status labels for every control number of raw materials in space provided on page, or back side of page Status labels of raw materials............/...........

1.2.2 Fazu odmeravanja raditi prema SOP.FRMOD 005/All operation procedures for dispensing start uo followed by SOP.FRMOD 005.........../...........

1.2.3 Postupak prosejavanja sirovina i oprema na kojoj se vri, definisan je sopom SOP.FRM.PR 336 Sejanja sirovina./Equipment and procedures for sieving, are defined with the document SOP.FRM.PR 336 Sieving of raw materials............/...........

1.2.4 Odmeravanje sirovina/ Dispensing of raw materialsParametri/ParametersIzvrio/Proverio/ Performed/Checked by:

1.2.4.1 Odmeri sledee materijale/ Dispense following materials:

Glimepirid, mikronizirani/Glimepiride, micronised 4,00 kg

Na vagi do 30kg inv.br.13635/Weighing balance up to 30kg I.D.No 13635

Kontrolni broj/Control number .............................. kg.........../...........

Kontrolni broj/Control number .............................. kg.........../...........

UKUPNO/Total:..................... kg.........../...........

Laktoza, monohidrat 350/Lactose, monohydrate 35068,0 kg

Na vagi do 300/600kg inv.br.13636/ Weighing balance up to 300/600kg I.D.No 13636

Kontrolni broj/Control number .............................. kg.........../.............


UKUPNO/Total:

..................... kg.........../.............

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 TABLETA (nastavak)/ DISPENSING OF RAW MATERIALS FOR 1 000 000 TABLETS (cont.)

FAZA/ PHASE

1.2.4 Odmeravanje sirovina (nastavak)/ Dispensing of raw materials (continued)Parametri/ParametersIzvrio/Proverio/ Performed/Checked by:

1.2.4.1 Odmeriti sledee materijale/ Dispense following materials:

Laktoza, monohidrat 350/ 70,0 kgLactose, monohydrate 350

Na vagi do 300/600kg inv.br.13636Weighing balance up to 300/600kg I.D.No 13636



UKUPNO/Total:..................... kg.........../.............

Pigment prah PB-20978, plavi/ Pigment blend PB-20978, blue1,80 kg

Na vagi do 30kg inv.br.13635Weighing balance up to 30kg I.D.No 13635



UKUPNO/Total:..................... kg.........../.............

Mikrokristalna celuloza PH 101 Microcrystalline cellulose Type 10125,0 kg

Na vagi do 300/600kg inv.br.13636Weighing balance up to 300/600kg I.D.No 13636



UKUPNO/Total:..................... kg.........../.............

Povidon K 30/Povidone K 30 2,00 kg

Na vagi do 30kg inv.br.13635/

Weighing balance up to 30kg I.D.No 13635



UKUPNO/Total:..................... kg.........../.............

Natrijum skrob glikolat, tip A/ 8,00 kg

Sodium starch glycolate, type A

Na vagi do 30kg inv.br.13635/

Weighing balance up to 30kg I.D.No 13635



UKUPNO/Total:

..................... kg

.........../.............

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 tableta (nastavak)/ DISPENSING OF RAW MATERIALS FOR 1 000 000 TABLETS (cont.)

FAZA/ PHASE

1.2.5 Odmeravanje za homogenizaciju/ Dispensing for blendingParametri/ParametersIzvrio/Proverio/ Performed/Checked by:

1.2.5.1 Odmeriti sledee materijale/ Dispense following materials:

Magnezijum stearat/ 1,20 kgMagnesium stearate Na vagi do 30kg inv.br.13635/Weighing balance up to 30kg I.D.No 13635Kontrolni broj/Control number .........Kontrolni broj/Control number .........UKUPNO/Total:

........................ kg........................ kg........................ kg

........../....................../....................../............

1.2.6 Upii ifru i kontrolni broj upotrebljenih kesa za odmeravanje:/Write code and control number of used food safety bags for dispensed material: ifra/Kontrolni broj/ ............................... Code/Control number ifra/Kontrolni broj/ ............................... Code/Control number ifra/Kontrolni broj/ ............................... Code/Control number ifra/Kontrolni broj/ ............................... Code/Control number

........../..........

........../..........

........../..........

........../..........

1.2.7 Upii oznaku mesta paletnog materijala/ Write palette mark of dispensed material: Oznaka paletnog mesta/..........................Palette mark:

1.2.8 U sluaju odstupanja od tehnolokog propisa popuni i priloi zapis Izvetaj o devijacijama./In the case of deviation, write and attach Deviation report to the Batch Record.

Napomena/Note:

..................................................................................................................

....................................................................................................................................................................................................................................

Zavretak faze odmeravanja/End of dispensing stage:

Datum/Date:

Vreme/Time:

Potpis inenjera odmeravanja/Signature of dispensing engineer:

Datum/Date:

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 tableta/DISPENSING OF MATERIALS FOR 1 000 000 TABLETS1.3 OZNAKE STATUSA SIROVINA/STATUS LABELS OF RAW MATERIALS


Datum/Date:

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 tableta/DISPENSING OF MATERIALS FOR 1 000 000 TABLETS1.3 OZNAKE STATUSA SIROVINA (nastavak)/STATUS LABELS OF RAW MATERIALS (continued)

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 tableta (nastavak)/ DISPENSING OF MATERIALS FOR 1 000 000 TABLETS (continued)1.4 OZNAKE ODMERENIH SIROVINA/THE LABELS OF DISPENSED MATERIAL


Datum/Date:

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 tableta (nastavak)/ DISPENSING OF MATERIALS FOR 1 000 000 TABLETS (continued)1.4 OZNAKE ODMERENIH SIROVINA (nastavak)/THE LABELS OF DISPENSED MATERIAL (cont.)


Datum/Date:

PRVA FAZA/PHASE ONE: ODMERAVANJE MATERIJALA ZA 1 000 000 tableta (nastavak)/ DISPENSING OF MATERIALS FOR 1 000 000 TABLETS (continued)1.4 OZNAKE ODMERENIH SIROVINA (nastavak)/THE LABELS OF DISPENSED MATERIAL (cont.)


Datum/Date:

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION


- U toku rada nositi zatitnu masku, rukavice i naoare./ Wear prevention mask, glasses and gloves.

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION

Poetak faze/Start:

Datum/Date:

Vreme/Time:

Potpis/Signature:

FAZA PRIPREME GRANULATA/GRANULATION

2.1 Priprema/Checking Izvrio/Proverio/Performed/Checked by:

2.1.1 Proveri/Check:Prisustvo liste o raienosti linije/Line clearance checklist

........./.........

2.1.2 Proveri status opreme za granulaciju/Check status of granulation equipment:

Oprema/EquipmentInv.br./ SystemI.D.NoDnevnici/zapisi/datum/ Logbooks No/dateIzvrio/Proverio/Performed/ Checked by:

1Pokretni sud za pripremu rastvora/Mobile solution vessel........./.........

Brzi mea Diosna 600/High shear mixer Diosna 60000332........./.........

Suare GLATT WSG-200 CD/Fluid Bed Dryer-GLATT WSG-20000327........./.........

Kran za podizanje i izvrtanje GLATT WSG-200 sa pripadajuim kolicima/ Pillar Hoist-FBD Bowl inventar 01660........./.........

1Pokretni rotacioni mlin LB Bohle Turbo Sieve- BTS 200 Ex/Rotary mill Turbo Sieve BTS 200 Ex Bohle........./.........

1Buck IBC kontejnera za prihvat prosejanog granulata zap.600l/ Intermediate Bulk Container IBC 600l........./.........

Buck IBC blender-a SP 1000/ Buck IBC blender SP 100014642........./.........

Podna vaga SARTORIUS IF S4-600 RN-NCE/Weighing balance SARTORIUS IF S4-600 RN-NCE14727........./.........

2Runo sito veliine otvora 180 m/ Hand sieve 180 m........./.........

2Runo sito veliine otvora 250 m/ Hand sieve 250 m........./.........

1ostalo/other:........./.........

1ostalo/other:........./.........

1 Runo upisivanje inventarnih brojeva ureaja/System I.D.No of equipment will be written manually2 Runo upisivanje serijskih brojeva sita/Serial number of sieves will be written manually

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION (continued)2.1.3 OZNAKE STATUSA PROSTORIJE I OPREME/STATUS LABELS OF EQUIPMENT AND GRANULATION ROOM

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION (continued)2.1.3 OZNAKE STATUSA PROSTORIJE I OPREME (nastavak)/STATUS LABELS OF EQUIPMENT AND GRANULATION ROOM (continued)

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION (continued)2.1.3 OZNAKE STATUSA PROSTORIJE I OPREME (nastavak)/STATUS LABELS OF EQUIPMENT AND GRANULATION ROOM (continued)

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION (continued)2.1.4 OZNAKE UPOTREBLJENIH SIROVINA/THE USED LABELS IN GRANULATION

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION (continued)2.1.4 OZNAKE UPOTREBLJENIH SIROVINA (nastavak)/THE USED LABELS IN GRANULATION (continued)

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION (continued)2.1.4 OZNAKE UPOTREBLJENIH SIROVINA (nastavak)/THE USED LABELS IN GRANULATION (continued)

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA/GRANULATION OPERATION (continued)

2.2 Suvo meanje granulata ubrzom meau DIOSNA P600/ Dry blending of material in high shear mixer DIOSNA P600Izvrio/proveriodatum/vreme/Performed by/Checked by:/Date/Time:

2.2.1 Izaberi sa glavnog ekrana funkciju, za rad sa ureajem HSM u runomreimu rada./Choose a function from main screen for manual adjusment of parameters......... / ................ / ........

2.2.2 U brzi mea DIOSNA P600 inv.br. 00332 ubaci odmerene materijale uprvoj fazi prema taki 1.2.5.1 sledeim redosledom:/ Add the following items, which are dispensed according to Phase one, point 1.2.5.1, into DIOSNA P600 I.D.No 00332 into prescribed order: - Laktoza monohidrat/Lactose monohydrate- Glimepirid mikronizirani/Glimepiride, micronised- Laktoza monohidrat/Lactose monohydrate- Pigment prah PB-20978, plavi, prosej kroz runo sito veliine otvora180 m i dodaj u DIOSNU/Sieve pigment blend PB-20978 blue throught 180 m hand sieve, and add to DIOSNA. - Mikrokristalna celuloza PH 101/Microcrystalline cellulose Type 101- Povidon K 30/Povidone K 30- Natrijum skrob glokolat,tip A/Sodium starch glycollate type A

Napomena/Note: Malu koliinu pigmentnog praha PB-20978, plavog, koja zaostane na situ ne dodavati u DIOSNU./ The remaining small quantity of pigment blend PB-20978 blue which does not pass through the sieve should not be added to DIOSNA.

........ / ................ / ........

2.2.3 Umeavanje granulata u brzom meau/Parameters in DiosnaVrednost/Opseg (Jed.)/Value/Range (Unit)Ostvarenavrednost/Actual valueIzvrio/proveriodatum/vreme/Performed by/Checked by:/Date/Time:

2.2.3.1 Homogenizuj materijale prema zadatim vrednostima/Mix Diosna contents according to parameters:vreme predmeanja/time of mixingbrzina meaa/mixer speedbrzina sekaa/chopper speed

3 min 95 5 rpm 84010 rpm

...... min...... rpm...... rpm

........ / ................ / ........

2.3 Suvo sejanje na pokretnom rotacionom mlinu LB Bohle Turbo Sieve BTS 200 Ex/Sreening through LB Bohle Turbo Sieve BTS 200 Ex Vrednost/Opseg(Jed.)/Value/Range (Unit)Ostvarenavrednost/ Actual valueIzvrio/proveriodatum/vreme/ Performed by/Checked by:/Date/Time:

2.3.1 Suvu masu granulata prosej na pokretnom rotacionom mlinu LB Bohle/ Discharge the blend through rotary mill Turbo Sieve BTS 200 Ex Bohle Turbo Sieve BTS 200 Ex, na situ veliine otvora/with a screeni brzini/and speed

0,8 mm 30050 rpm

...... mm...... rpm

........ / ................ / ........

2.3.2 Prosejani granulat prenesi u brzi mea DIOSNA P600/Transfer back the screened mixture to DIOSNA P600.

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/GRANULATION OPERATION (continued)2.4 Priprema rastvora za granulaciju/ Preparation solution granulationParametri/ParametersOstvarena vrednost/Actual valueIzvrio/proveriodatum/vreme/ Performed by/Checked by:/Date/Time:

2.4.1 U pokretni sud za pripremu rastvora sipaj preienu vodu /Transfer the purified water in mobile solution vessel:temperature/with a temperature of odmerenu na vagi inv.br.14602/ which is dispensed on the weighing balance I.D.No 14602 34,2 kg

205 C

............ kg

............ C

....... / ....... ....... / .......

2.5 Vlana granulacija/Wet granulation

2.5.1 Izaberi sa glavnog ekrana funkciju, za rad sa ureajem HSM u runom reimu rada/Choose a function from main screen for manual adjusment of parameters........ / ....... ....... / .......

2.5.2 Umeavanje granulata u brzom meau/ Parameters in DIOSNAVrednost/Opseg (Jed.)/Value/Range (Unit)Ostvarenavrednost/ Actual valueIzvrio/proveriodatum/vreme/Performed by/Checked by:/Date/Time:

2.5.2.1 Homogenizuj materijale prema zadatim vrednostima/Mix Diosna contents with following parameters:vreme predmeanja/pre-blending timebrzina meaa/mixer speed brzina sekaa/chopper speed

2 min 95 5 rpm 84010 rpm

...... min...... rpm...... rpm

....... / .............. / .......

2.5.2.2 Doziraj rastvor za granulaciju (bez dizne) pritiskom na taster za sprej sa sledeim parametrima/Spray water into the Diosna with following parameters:pritisak vazduha pumpe za rasprivanje rastvora/solution pump air pressurebrzina meaa/mixer speedbrzina sekaa/chopper speeddo utroka celokupne koliine rastvora/ until the whole amount of water is sprayed.

3,50,5 bar 95 5 rpm 84010 rpm 34,2 kg

...... bar...... rpm...... rpm ....... kg

2.5.2.3 Umeavaj granulat pri sledeim parametrima/Mix wet granulate with following parameters:broj obrtaja meaa/mixer speed broj obrtaja sekaa/chopper speedvreme umeavanja/mixing time

955 rpm 100010 rpm 2 min

...... rpm ...... rpm ...... min

Napomena/Note:

...........................................................................................................................

...........................................................................................................................

...........................................................................................................................

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/GRANULATION OPERATION (cont.)

2.5.2.4 Praenje parametara procesa vlane granulacije (na svaki minut)/Checking of wet granulation parameters (on every minute)

Prit.vazd.pum.za rast./barSolution pump airpressure (bar)Brzina sek. (rpm)/Chopper speed(rpm)Brzina me. (rpm)/Mixer speed(rpm)Protok rast.(kg/min)Binder solution flow rate(kg/min)Pritisaku rast.(bar)Pressurein fluid(bar)Vremeprocesa(min)/Duration(min)Opter.me. (A)/ Mixer load(A)Izvrio/ Proverio/Performed/Checked by:

Zad.Set

Ostv.ActualZad.Set

Ostv. ActualZad.Set

Ostv.ActualKol. rast. (kg)/Amount of solution (kg)

Faza predmeanja/Pre-blending phase

Faza nanoenja rastvora za granulaciju/Spraying water phase

Faza umeavanja granulata/Mixing phase

Zavrne take granulacije u DIOSNI P600/ Granulation end points at DIOSNA P600:Opseg/RangeIzvrio/proverio/datum/vremePerformed by/Checked by:/Date/Time:

vreme predmeanja/pre-blending time ............. minvreme dodavanja rastvora za granulaciju/time of spraying all water: ............. minumeavanje granulata/mixing of granulate: optereenje meaa/mixer load ............. A 2 min 52 min Kao inf./for info only

................/..................................../....................

FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/GRANULATION OPERATION (continued)

2.6 Sejanje vlanog granulata/ Wet granule screeningVrednost/Opseg (Jed.)/Value/Range (Unit)Ostvarena vrednost/ Actual valueIzvrio/proveriodatum/vreme/Performed by/Checked by:Date/Time:

2.6.1 Vlanu masu granulata prosej na pokretnom rotacionom mlinu LB Bohle Turbo Sieve BTS 200 Ex/Screen wet granule through rotary mill Bohle Turbo Sieve BTS 200 Ex Bohle, na situ veliine otvora/with a screeni brzini/and speed

10,0 mm 700-750 rpm

...... mm ...... rpm

........ / ................ / ........

2.6.2 Prosejani granulat prihvati u kolica ureaja Glatt WSG 200/Transfer screened granulate to the FBD-Glatt WSG 200 bowl.

Napomena/Note:

.....................................................................................................................

.....................................................................................................................

.....................................................................................................................

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/GRANULATION OPERATION (continued)

2.7 Suenje granulata/Drying in FBD

2.7.1 Faze u suenju granulata/ Parameters in FBDVrednost/Opseg (Jed.)/Value/Range(Unit)Ostvarena vrednost/Actual valueIzvrio/proveriodatum/vreme/Performed by/Checked by:/Date/Time:

2.7.1.1 Izaberi sa glavnog ekrana funkciju, za rad sa ureajem FBD, u automatskom reimu rada i zadaj podatke za fazu predmeanja/Choose a function from a main screen for automatic adjusment of parameters:- protok ulaznog vazduha/inlet air flow rate- ulazna temperatura vazduha/inlet air temperature- vreme suenja/time of drying

7000300 m3/h 353C 52 min

For info.only

For info.only

For info.only

........./................./........

2.7.1.2 Po zavretku faze predmeanja promeni parametre za suenje granulata/When the phase of pre-blending is finished, change the drying parameters:-temperatura ulaznog vazduha/inlet air temperature -protok ulaznog vazduha/inlet air flow rate-interval otresanja filtra/shaker interval time -trajanje otresanja filtra/shaker duration time

-temperatura proizvoda/product temperature

602C

3000100m/h

60 s 6 s

382 C

......C

..... m/h

..... s..... s

......C

2.7.2 Faza hlaenja granulata/ Cooling phaseVrednost/Opseg (Jed.)/Value/Range(Unit)Ostvarena vrednost/Actual value

2.7.2.1 Nakon zavretka faze suenja iskljui FBD i ostavi granulat da se hladi 1minimum /After the end of drying phase leave the granulate to cool on standing for1 not less than

10 2min

For info. only

1idealno vreme hlaenja je oko tridest minuta/ target cooling time is thirty minutes

2.7.3 Parametre procesa suenja kontrolii neprekidno i belei na svakih 15 minuta./Control drying parameters, continously and record values every 15 minutes.

2.7.3.1 Praenje parametara procesa suenja/Control of FBD parameters

Vreme/ TimeTemp.ulaz.vazd.(C)/Inlet air temperature (C)Temp.izlaz.vazd./Outlet air temperatureKol.ulaz.vazd. (m/h)/ Inlet air flow rate(m/h)Temp. proizvoda/ Product temperatureIzvrio/Proverio/Performed/Checked by:

Zadata/ SetOstvarena/ ActualZadata/ SetOstvarena/ Actual

Faza predmeanja granulata u FBD/Pre- blending phase at FBD

Faza suenja granulata u FBD/Drying phase at FBD

Faza hlaenja granulata u FBD/Cooling phase at FBD

Zavrne take suenja u FDB/End points at FDB:Opseg/ RangeIzvrio/proverio datum/vremePerformed by/Checked by:/Date/Time:

- suenje granulata/drying:temp.proizvoda/product temperature ......... C

izlazna temperatura vazduha/outlet air temperature ........ C

vreme suenja/drying time ............. min382 C

kao inf./for info.only

kao inf./for info.only

2.7.3.2 Nakon zavretka procesa granulacije, odtampaj izvetaj o radu ureaja i priloi ga uz dosije o seriji/Attach all attained printouts from the granulation stage, to the Batch Record.

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA(nastavak)/GRANULATION OPERATION (cont.)

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/GRANULATION OPERATION (continued)

2.7.4 Odreivanje sadraja vlage/ Loss on dryingVrednost/Opseg (Jed.)/Value/Range (Unit)Ostvarena vrednost/Actual valueIzvrio/proveriodatum/vremePerformed by/Checked by:/Date/Time:

2.7.4.1 Suvi granulat, u koliini od 1kg, prosej na pokretnom rotacionom mlinu LB Bohle Turbo Sieve BTS 200 Ex/Screen approx. 1 kg of dried granule through LB Bohle Turbo Sieve BTS 200 Exna situ veliine otvora/with screeni brzini/and speed

0,8 mm35050 rpm

....... mm....... rpm ........./......... ........./.........

2.7.4.2 Uzmi uzorak granulataradi ispitivanja ostatka vlage na vlagomeru Sartorius MA 150 inv.br. 01691 na temperaturi od /Take a. granulate sample and perform moisture test on moisture balance Sartorius MA 150 I.D.No 01691 atCiljana vlaga granulata je u opsegu od/Final moisture riding before sieving of whole lot should be between

105C

1,0 2,0 %

.......... C

........... %........./......... ........./.........

2.7.4.3 Ukoliko je neophodno nastavi suenje granulata pri istim parametrima do postizanja zahtevanog ostatka vlage/If moisture result is outside limit, continue drying until LOD is whithin limits.

Napomena/Note:...............................................................................................................................................................................................................................................................................................................................................................

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/ GRANULATION OPERATION (continued)

2.7.5 Prosejavanje/ Sieving

2.7.5.1 Pokretni sud sunice GLATT WSG-200 privrsti za levak pripadajueg krana za podizanje i izvrtanje, podigni i izvrni./Load FBD Glatt WSG 200 bowl onto Pillar Hoist.

2.7.5.2 Postavi pokretni rotacioni mlin LB Bohle Turbo Sieve BTS 200 Ex ispod otvora levka krana za podizanje i izvrtanje. /Place rotary mill LB Bohle Turbo Sieve BTS 200 Ex below Pillar Hoist-FBD Bowl inventar.

2.7.5.3 Izmeri prazan IBC kontejner na digitalnoj vagi i zabelei koliinu./Weigh empty IBC container on digital balance and record attained value.Nakon merenja, odtampaj, overi i zalepi nalepnicu na poleini dosijea o seriji./After measuring, verify and affix printout to the back side of Batch Record............ kgIzvrio/proverio datum/vreme/Performed by/Checked by:/Date/Time:

2.5.4.3 ........./................../.........

2.7.5.4 Postavi IBC kontejner za prihvat prosejanog granulata ispod rotacionog mlina LB Bohle Turbo Sieve BTS 200 Ex./Place IBC container below rotary mill LB Bohle Turbo Sieve BTS 200 Ex.

2.7.5.5 Stavi motor rotacionog mlina u pogon i lagano otvori blendu levka kako bi omoguio ravnomeran dotok granulata./Start on rotary mill motor, open valve and continously fill hopper with granulate.

2.7.6 Sejanje suvog granulata/ Sieving-continuedVrednost/Opseg (Jed.)/Value/Range (Unit)Ostvarenavrednost/Actual valueIzvrio/proveriodatum/vreme/Performed by/Checked by:/Date/Time:

2.7.6.1 Osueni granulat prosej na pokretnom rotacionom mlinu LB Bohle Turbo Sieve BTS 200 Ex,/Pass dried granulate through rotary mill LB Bohle Turbo Sieve BTS 200 Ex, na situ veliine otvora/with a screeni brzini/and speed

0,8 mm 35050 rpm

.......mm.......rpm

........./................../.........

2.7.6.2 IBC kontejner sa prosejanim granulatom izmeri na digitalnoj vagi i zabelei koliinu. Nakon merenja, odtampaj, overi i zalepi nalepnicu na poleini dosijea o seriji./ Weigh mass of IBC container with milled granulate on digital balance and write attained value. After measuring, verify and affix printout to the backside of Batch Record. ....... kg

Napomena/Note:...............................................................................................................................................................................................................................................................................................................................................................

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/ GRANULATION OPERATION (continued)2.7.7 OZNAKE STATUSA PROSTORIJE I OPREME ZA FAZU HOMOGENIZACIJE/STATUS LABELS FOR EQUIPMENT AT BLENDING PHASE

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/ GRANULATION OPERATION (continued)2.7.8 OZNAKE UPOTREBLJENIH SIROVINA ZA FAZU HOMOGENIZACIJE/ THE USED LABELS IN BLENDING PHASE

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/ GRANULATION OPERATION (cont.)FAZA/ PHASE

2.8 Homogenizacija/ Dry blending

2.8.1 Pripremi oznaku Nije analizirano-ZP.FRM.017 za IBC kontejner u kome e biti skladirana serija granulata i oznai IBC kontejner./Prepare label Not analysed ZP.FRM.017 and affix it to IBC container, in which granulate will be stored.

Postupak/ ProcessVrednost/Opseg (Jed.)/Value/Range (Unit)Ostvarenavrednost/Actual valueIzvrio/proveriodatum/vreme/ Performed by/Checked by:/Date/Time:

2.8.2 Magnezijum stearat odmeren u prvoj fazi prema taki 1.2.6.1 prosej kroz runo sito veliine otvora 250m i dodaj u IBC kontejner sa prosejanim granulatom, zatvori i osiguraj poklopac IBC kontejnera, i homogenizuj granulatu jednom smeru na/Magnesium stearate which is dispensed according to Phase one, point 1.2.6.1 , screen through 250 m hand sieve and transfer to IBC container and blend on

5 min 10 rpm

............ min ............ rpm .........../....................../...........

2.6.4 2.8.3 Po zavrenoj homogenizaciji paljivo otvori poklopac na IBC kontejneru i uzmi uzorak granulata 2.6.5 radi ispitivanja ostatka vlage na vlagomeru Sartorius MA 150 2.6.6 inv.br. 01691 na temperaturi od/ After blending, take a blend sample and perform moisture test on moisture balance Sartorius MA 150 I.D.No 01691atCiljana vlaga granulata je u opsegu od/Final moisture riding should be between

105 C

1,0-2,0 %

.............. C

.............. % .........../....................../...........

2.8.4 IBC kontejner sa granulatom izmeri na digitalnoj vagi inv.br.14727 i zabelei masu na predvienom mestu na oznaci Nije analizirano ZP.FRM.017./Weigh mass of IBC container with blend, on digital balance I.D.No 14727 and write attained value on the marked place at the label Not analysed -ZP.FRM.017............... kg .........../....................../...........

2.8.5 Odtampaj nalepnicu sa podacima o izmerenoj koliini granulata, overi zalepi u Dosije o seriji./After measuring, verify and affix weighing printout to the back side of the Batch Record.


Napomena/Note:......................................................................................................................................................................................................................................................................................................................................................

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/GRANULATION OPERATION (continued)2.8.7 OZNAKE SA KOLIINAMA DOBIJENOG GRANULATA/THE LABELS WITH AMOUNT OF GRANULATE

DRUGA FAZA/PHASE TWO: PRIPREMA GRANULATA (nastavak)/GRANULATION OPERATION (continued)FAZA/ PHASE

2.9 Proraun prinosa/ Accounting of yield of granulateParametri/ParametersIzvrio/ Performed by:

Teorijska koliina/Material input (a):kg

Koliina odobrenog granulate/Approved amount of final blend (b)kg

Odbaena i uzorkovana koliina/Rejected and taken for analysis (c)kg

Prinos/Yield (%): 96100%%

bPrinos/Yield % = x 100 = x 100 = ............... % a

Proraun/Accountability:

b+c Prinos/Yield % = x 100 = x 100 = ............... % a

2.9.1 Upii ifre, kontrolne brojeve i brojeve PE kesa za prihvat granulata/Record codes, control No and numberof PE bags for granulate: ....................................................................................................................................................................................................................................................................................

Napomena/Note:

..................................................................................................................

..................................................................................................................

..................................................................................................................

Zavretak faze granulacije/End of granulation stage:

Datum/Date:

Vreme/Time:

Potpis inenjera Pogona proizvodnje/ Signature of production engineer:

Datum/Date:

TABLETIRANJE ODOBRENO/ COMPRESSION APPROVEDTABLETIRANJE NIJE ODOBRENO/COMPRESSION

NOT APPROVED

QP/delegirana osoba/QP person/Qualified person:

......................................................................................................

(ime i prezime/name)(potpis/signature)(datum/date)

TREA FAZA/PHASE THREE: TABLETIRANJE/COMPRESSION


- U toku rada nositi zatitnu masku i rukavice / Wear prevention mask and gloves.

TREA FAZA/PHASE THREE: TABLETIRANJE/COMPRESSION

Poetak faze/Start:

Datum/Date:

Vreme/Time:

Potpis/Signature:

FAZA TABLETIRANJA/COMPRESSION STAGE

3.1 Priprema/Checking Izvrio/Proverio/ Performed/Checked by:

3.1.1 Proveri/Check: - Prisustvo liste o raienosti linije/ Line clearance checklist

.........../..........

3.1.2 Proveri status opreme za tabletiranje/Check status of equipment for compression:

Oprema/EquipmentInv.br./ System I.D.NoDnevnici/zapisi/datum/ Logbooks No/dateIzvrio/Proverio/Performed/Checked by:

1Maina za tabletiranjeKilian E-150+/Compression machine Kilian E-150+01531.........../.........

1Maina za tabletiranjeKilian E-150/Compression machine Kilian E-150_.........../.........

2Otpraiva tableta KRMER E 2000A-250 IR/Tablet De-duster KRMER E 2000A-250 IR.........../.........

2Detektor metala Lock Met 30+/Metal detector Lock Met 30+

2Digitalne analitike vage SARTORIUS LA 310S/Digital balancesSARTORIUS LA 310S.........../.........

2Podne vage SARTORIUS CAPS 4150GF-LCE/Balances SARTORIUS CAPS 4150GF-LCE.........../.........

2Krana za podizanje IBC kontejneraHS 1000/Pillar hoist HS 1000.........../.........

2IBC kontejner IBC container.........../.........

2Set alata/Tools set.........../.........

2ostalo/other:.........../.........

2ostalo/other:.........../.........

1 Potvrdi znakom () koju mainu koristi za tabletiranje/Confirm with the mark () which machine you use for tabletting2 Runo upisivanje inventarnih brojeva ureaja/System I.D.No of equipment will be written manually

TREA FAZA/PHASE THREE: TABLETIRANJE (nastavak)/COMPRESSION (continued)3.1.3 OZNAKE STATUSA PROSTORIJE I OPREME/STATUS LABELS OF COMPRESSION ROOM AND EQUIPMENT

TREA FAZA/PHASE THREE: TABLETIRANJE (nastavak)/COMPRESSION (continued)3.1.3 OZNAKE STATUSA PROSTORIJE I OPREME (nastavak)/STATUS LABELS OF COMPRESSION ROOM AND EQUIPMENT (continued)

TREA FAZA/PHASE THREE: TABLETIRANJE (nastavak)/COMPRESSION (continued)

FAZA/ PHASE

3.2 Priprema i podeavanje parametara/Compression stage set-upIzvrio/ Performed by:

3.2.1 Pripremi pogodne odgovarajue sudove za prihvat tableta i svaki oznai oznakom Nije analizirano-ZP.FRM.017 i obelei rednim brojevima neposredno pre prihvata tableta./Prepare suitable containers for receiving tablets, mark it with label Not analysed- ZP.FRM.017 and with ordinal numbers, before compression start.

3.2.2 Pripremi kontejner za prihvat proizvoda izdvojenog pri autokontroli i oznai ga oznakom Izdvojeno pri autokontroli- ZP.FRM.016/ Prepare suitable container for receiving of rejected tablets, which will be taken during autocontrol, and mark it with label Taken during autocontrol- ZP.FRM.016.

3.2.3 Pomou krana za podizanje IBC kontejnera, podigni i pozicioniraj IBC kontejner iznad levka za doziranje./Put the IBC container with blend on discharge station.

3.2.4 Povei mainu za tabletiranje sa crevom centralnog otpraivaa maine./Connect the tablet press with de-duster.

3.2.5 Postavi otpraiva tableta na izlazu iz maine za tabletiranje./Connect the tablet press with metal detector.

3.2.6 Izvedi test provere rada detektora metala, proputanjem kroz njega priloenih test tableta po prvom startu maine. Evidentiraj u Dnevniku rada pomone opreme svaki naredni test. Oznai posudu za prihvat odbaenih tableta sa metal detektora nalepnicom Izdvojeno pri autokontroli- ZP.FRM.016./Test the metal detector. Write down every subsequent test in appropriate logbook. Collect rejected tablets in container marked with label: Taken during autocontrol- ZP.FRM.016.

3.2.7 Izvri kontrolu rada digitalne analitike vage, priloenim tegom, na poetku svake smene i upii podatke u dnevnik kontrole rada vage./Check working of analytical balance at the beginning of every shift and write attained data in the appropriate logbook.

3.2.8 Otvori ventil IBC kontejnera sa granulatom i polako napuni dozator maine./Open the IBC bottom valve and fill hopper with granule

3.2.9 Ukljui mainu za tabletiranje./Operate the fill-o-matic and fill the feeder with granule.

3.2.10 Otvori ventil dozatora i startuj motor maine./Jog machine to fill all dies and start compression.


3.3 Podeavanje parametara/ Parameters adjustmentVrednost/Opseg (Jed.)/ Value/Range (Unit)Ostvarena vrednost/ Actual valueIzvrio/datumvreme: Performed by: Date/Time:

3.3.1 1Na displeju ureaja podesi sledee parametre/ Adjust following parameters:- glavni pritisak/main pressure- predpritisak/pre-pressure- dubina punjenja/filling depth- brzina rada maine/compression speed (No of tabl./h)

2-5 mm 2-5 mm 5-7 mm140 000 10 000tbl/h

..........mm..........mm..........mm........tbl/h

......................./.......

3.3.2 2Na displeju ureaja podesi sledee parametre/ Adjust following parameters:- glavni pritisak/main pressure- predpritisak/pre-pressure- dubina punjenja/filling depth- brzina rada maine/compression speed (No of tabl./h)

..........mm ..........mm..........mm........tbl/h

..........mm..........mm..........mm........tbl/h

......................./.......

3.3.2 Podesi sledee parametre tabletnih jezgara/Adjust tablet parameters:- prosena masa tableta/average tablet weight- donja granica mase tableta/lower limit of average tablet weight- gornja granica mase tableta/upper limit of average tablet weight- vrstina (tvrdoa)/resistance to chrushing- debljina/thickness

180,0 mg 171,0 mg 189,0 mg

40-90 N 3,0-3,5 mm

.........mg.........mg

.........mg

........N ....... mm

......................./.......

1maina za tabletiranje Kilian E 150+ /compression machine Kilian E 150+2maina za tabletiranje Kilian E 150/ compression machine Kilian E 150

TREA FAZA/PHASE THREE: TABLETIRANJE (nastavak)/COMPRESSION (continued)FAZA/ PHASE

3.4 Tabletiranje/Compression

3.4.1 Parmetre tabletiranja: debljina tableta, prosene i pojedinane mase tableta pratiti na ureajima operatera svakih 30 min i beleiti u Dosjeu o seriji./Check thickness, average, and individual masses of tablets, every 30 minutes. Write attained values in the table below. Parameters are to be checked by operators.

3.4.2 Autokontrola parametara tabletiranja/Autocontrol of tablet parameters:

Datum/as/Date/TimeKoliina uzorka (g)/Amount of sample (g)Prosena masa 20 tbl./ (mg)Average mass of 20 tablets(mg)Pojedinanemase 10 tbl./(mg)Individual massof 10 tablets (mg)vrstinapojedinane vrednosti (N)/Resistance to crushingindividual values(N)Debljina pojed.vrednosti (mm)/ThicknessIndividual values (mm)Izvrio/Performed by:


FAZA/ PHASE





FAZA/ PHASE




TREA FAZA/PHASE THREE: TABLETIRANJE (nastavak)/COMPRESSION (continued)FAZA/ PHASE



Datum/ as/Date/TimeKoliina uzorka (g)/Amount of sample (g)Prosena masa 20 tbl./ (mg)Average mass of 20 tablets(mg)Pojedinanemase 10 tbl./(mg)Individual massof 10 tablets (mg)vrstinapojedinane vrednosti (N)/Resistance to crushingindividual values(N)Debljina pojed.vrednosti (mm)/ThicknessIndividual values (mm)Izvrio/Performed by:


FAZA/ PHASE



3.4.4 Tokom procesa tabletiranja proizvedene tablete, tablete uzorkovane sa maine radi autokontrole, laboratorijske analize, procesne kontrole, izdvojene pri radu metal detektora kao i sav izdvojeni neusaglaeni proizvod odvajati u posebnu ambalau i beleiti u sledeoj tabeli:/During compression, collect all rejected material (such as tablets which are used for autocontrol, analyses, in process control, checking of metal detector) in special container. Taken amount of tablets are to be written in the table below.

3.4.5 Nakon merenja proizvedene koliine tableta, odtampaj nalepnice sa podacima u dva primerka, i jedan zalepi na kontejner za tablete, a drugi u Dosijeu o seriji./After measuring weigh of produced tablets, print attained result in two copies. Affix one copy to the back side of this sheet and the other to the container with tablets.

Datum/as/Date/TimeProizvedeno/(d) (kg)Produced(d) (kg)Izdvojeno pri autokontroli i procesni kart(f) (kg)/Taken during autocontrol and rejected material(f) (kg)Izdvojeno priradu metal detektora(g)(do 1000kom) (kg)/ Rejected during check of metal detector (g)(max 1000)(kg)Uzorkovano za analizu(e) (kg)/ Taken for analyses(e) (kg)Izvrio/ Performedby:

Datum/asDate/Time:

........................ kg

........... kg

.......... kom(kg)

........... kgKontrolisao tabl.Controlled by:

.................


3.4.6 100% VIZUELNA KONTROLA/SORTIRANJE/100% VISUAL CONTROL/ SORTING

OPIS NEUSAGLAENOSTI I KOLIINA NEUSAGLAENOG PROIZVODA1/ Description of discrepancies and quantity of offset product: ....................................................................................................................................................................................................................................

Broj Izvetaja o devijaciji:/ Number of deviation report:

Datum:/ Date:Potpis:/ Signature:

FAZA/ PHASE

Na osnovu opisa neusaglaenosti definisanog od strane kontrole u procesu izvriti:/ According to described descrepancies defined by in-process control should be carried out:

100% VIZUELNU KONTROLU / VISUAL CONTROL SORTIRANJE/ SORTING (zaokruiti operaciju/ encircle operation)

Datum:/ Date:

Potpis:/ Signature:

Datum/vreme poetka:/Date/time of biginning:

DatumDatearaBatchKontejnerContainerKoliina (kg)/ Amount (kg)PotpisSignatureStatus1StatusPotpis1Signature

PoetnaStarted

PregledanaCheckedIzdvojenaOut of specific.

Datum/vreme zavretka:Date/time of ending:

..................Ukupno (kg):Total:

................................................................

1 Popunjava kontrola u procesu/ fill in in-process control

TREA FAZA/PHASE THREE: TABLETIRANJE (nastavak)/COMPRESSION (continued)3.4.7 KOLIINA PROIZVEDENIH TABLETA/THE LABELS WITH PRODUCED AMOUNT OF TABLETS

TREA FAZA/PHASE THREE: TABLETIRANJE (nastavak)/COMPRESSION (continued)3.4.7 KOLIINA PROIZVEDENIH TABLETA (nastavak)/THE LABELS WITH PRODUCED AMOUNT OF TABLETS (continued)


FAZA/ PHASE

3.5 Proraun prinosa tabletiranja u odnosu na dobijenu koliinu granulata/ Accounting of the theoretical yield, according to tablet blendingParametri/ParametersIzvrio/ Performed by:

Koliina odobrenog granulata/Approved amount of granulate (b)kg

Ukupna koliina odobrenih tableta/Total amount of tablets (d+e+f+g)kg

Koliina odobrenih tableta/Approved amount of tablets (d)kg

Uzorkovana koliina/Amount taken for analyses (e):kg

Izdvojeno pri autokontroli i procesni kart/Taken during autocontrol and rejected material(f)kg

Izdvojeno pri radu metal detektora/Rejected during check of metal detector (g)kg

Izdvojeno pri vizuelnoj kontroli/ Taken for visual control (h) kg

Oekivani prinos (%), ne manji od 95 %/Expected yield (%), not less than 95%:%

dPrinos/Yield % = x 100 = x 100 = ............. % b

Proraun/Accountability:

(d+e+f+g+h)Prinos/Yield % = x 100 = x 100 = ............. % b

3.5.1 Upii ifre, kontrolne brojeve i brojeve PE kesaza prihvat tabletnih jezgara./ Record codes, control No and nubers of PE bags for tablet cores....................................................................................................................................................................................................................................................................................................................................................

Napomena/Note:

.................................................................................................................

.................................................................................................................

.................................................................................................................

Zavretak faze tabletiranja/End of compression stage:Datum/Date:

Vreme/Time:

Potpis inenjera Pogona proizvodnje/ Signature of production engineer:

Datum/Date:

III. PREGLED DOSIJE-a O PROIZVODNJI SERIJE/ REVIEW OF BATCH MANUFACTURING RECORD

Odgovorna osoba/Responsibile person:

1. Rukovodilac Pogona proizvodnje/Solids production chief officer:

..................................................................................................


PAKOVANJE ODOBRENO/ PACKAGING APPROVEDPAKOVANJE NIJE ODOBRENO/

PACKAGING NOT APPROVED

QP/delegirana osoba/QP person/Qualified person:

..................................................................................................


ISTORIJA IZMENA/HISTORY OF CHANGES

Brojkontrole izmene/Change Control No.Verzija/VersionRazlog izmene/ Reason for changeDatum izdanja/Date of issuing

KID08/0587/KID08/09981.0Priprema dokumentacije za noviproizvod Glimepirid 1mg tableta(eksterni transfer proizvoda)/Preparing of documentation for new product Glimepiride 1mg tablets (product transfer)20.02.08.24.03.08.

KID08/3120/KID08/31672.0Usaglaavanje dokumentacije/Documentation update02.10.08.03.10.08.

KI10/05863.0Izdavanje dvojezinog dosijea iUsaglaavanje dokumentacije/Issuing of bilingual document and documentation udate15.07.10.

Datum primene/Effective date: Datum prestanka vaenja/Expire date:

Kontrolisan dokument/Ne kopirati bez dozvole/Controlled document/ Do not copy without permission Strana/Page 1 od/of 54

Datum primene/Effective date: Datum prestanka vaenja/Expire date:

Kontrolisan dokument/Ne kopirati bez dozvole/Controlled document/ Do not copy without permission Strana/Page 54 od/of 54

Documents

Ds.prz.0065 - Glimepirid 4mg Tbl.- Srp.eng.- V.3.0