BMR Sugar Coated Placebo Tablets

Page 1 of 19 BATCH MANUFACTURING RECORD PRODUCT NAME: FORM: BATCH SIZE: PACKAGING: BOTTLE:

CAP:

Sugar-Coated Placebo (Sugary V®) Tablets

BATCH NO.:

Sugar-Coated Tablets !500 tablets 100 tablets"bottle 100-#$ %&de-#out' a#ber fl&t

FMSI-15I01-01

PROCESS START AND COMPLETION TIMES Start Time: Date: Competio!

Time: Date:

APPRO"ED B#: Faer&e Carlee $uc&le $, l#&ra (Su+er.&sor)

lac* +last&c scre%-o

/u&e.ere , Cas&#+a (Su+er.&sor) 

PERSONNEL INFORMATION E$a%atio! Name

Da- 1

Po&itio! 'Ma(or)Mi!or* Da- 2 Da- 

l#&ra! F, F,

C

Su+er.&sor

Su+er.&sor

l.arado! 2,

C

C

C

a3uela! 2,

C

C

C

Cabrega! P,

C

C

C

Ma& t teace



Su+er.&sor

C

Castro! 4,




ebu6ue! 7,




ela 8osa! 4,

&s+es&g

&s+es&g" Pac*ag&g

ula%a! 2,

&s+es&g

&s+es&g

:ao! 4,

&s+es&g

&s+es&g

Floret&o! ,

Product&o

Product&o

/utlay! 4,

Product&o

Product&o

$&ba! $,

Product&o

Product&o

V&llafuerte! 2,

Product&o

Product&o

&s+es&g" Pac*ag&g &s+es&g" C &s+es&g" C Product&o" Pac*ag&g Product&o" Pac*ag&g Product&o" Pac*ag&g Product&o" Pac*ag&g

Ca'&l&g! , Cas&#+a! /,

Si+! Si+!at at%r %re e

P%!, P%!,t% t%a ait it-

Prepare/!e&&

Su+er.&sor

MANUFACTURING LOCATION: I!/%&tria P3arma,- La4orator-: Soi/& Room MA5OR E6UIPMENT: Coati!+ pa! BATCH DOCUMENT ISSUED B#:

DATE:

MASTER DOCUMENT EFFECTI"E:

SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:

F8I C8$7 $;CI$ $, $MI8 /;I7V8 , CSIMP7 CSI MP7 Date:

I!itiati$e0

Tota

Page < of 19 BATCH MANUFACTURING RECORD PRODUCT NAME:


FORM: BATCH SIZE: PACKAGING: BOTTLE:

BATCH NO.:


CAP:

FMSI-15I01-01


Time: Date:




FORMULA AND 7EIGHING RECORD CODE

MATERIAL Placebo Tablets

AMOUNT

ACTUAL AMOUNT

DISPENSED B#

CHECKED B#

!500,00 g

Seal Coating Solution 4oll&do V =>®

?9,50 g

t'aol! 95@

1=5,00 #$

Subcoating Solution Sucrose

5>>,50 g

cac&a

<<,0 g

/elat&

<<,0 g

&st&lled %ater

=,00 #$

Grossing Syrup Sucrose

>?<,50 g

Subcoat&g +o%der

A?,<0 g

Colorat (10@)

6s

&st&lled %ater

<=>,00 #$


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:

F8I C8$7 $;CI$ $, $MI8 /;I7V8 , CSIMP7 Date:

DATE

Page  of 19 BATCH MANUFACTURING RECORD PRODUCT NAME: FORM: BATCH SIZE: PACKAGING: BOTTLE:

CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




Heavy Syrup Sucrose

95,15 g

Colorat (10@)

6s

Syru+! 7F

1<,00 #$

Regular Syrup Sucrose

111,10 g

Colorat (10@)

6s

&st&lled %ater

1<,00 #$

Polishing Solution Sucrose

<0,00 g

P/ A000

0,00 g

&st&lled %ater

50,00 #$

Name o8 Di&pe!&er: BBBBBBBBBBBBBBBBBBBBBBBB

Name o8 C3e,9er: BBBBBBBBBBBBBBBBBBBBBBBBB

Si+!at%re: BBBBBBBBBBBB

Si+!at%re: BBBBBBBBBBBB

MANUFACTURING INSTRUCTION AND RECORD


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


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CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




1

Name o8 Operator: 

Name o8 C3e,9er: BBBBBBBBBBBBBBBBBBBBBBBBBB

Si+!at%re: BBBBBBBBBBBBBBB

Si+!at%re: BBBBBBBBBBBBBBB

PROCEDURE C'ec* t'e Plat $og! ad eter deta&ls of follo%&g 1,1 Pre.&ous e6u&+#et use Product atc' 7o, ate

DATE

TIME

OPERATOR

1,< $ast e6u&+#et cleado% ate < Mo&tor t'e follo%&g Te#+erature 8elat&.e Du#&d&ty  Ebta& clearace fro# Product&o Su+er.&sor ad C t'at e6u&+#et ad %or* area are clea ad ready for use, Ma&teace C clearace Prod, Su+er.&sor clearace , > Scree ad dedust tablets, 5 Seal Coat&g


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


CHECKER


CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




a,

++ly 50 #l of seal coat&g solut&o ra+&dly ad allo% t'e tablets to roll! %&t' 'ad ag&tat&o! &f ecessary! +er#&tt&g t'e solut&o to s+read %ell o.er t'e et&re tablet bed, 1st ++l&cat&o <d ++l&cat&o rd ++l&cat&o

b,

Per#&t t'e tablets to roll ut&l t'ey beg& to beco#e tac*y! res&st se+arat&o! ad ad'ere to eac' ot'er ad to t'e +a, t t'&s +o&t t'e tablets s'ould be dusted %&t' asbestos-free talc ut&l t'ey ust lose t'e&r tedecy to ad'ere to oe aot'er, $et t'e tablets roll for  to 5 #&utes to +re.et agglo#erat&o, T&#e Started T&#e ded

Total T&#e , 'g'fdtutf&ygou&g&ygb&ugb&ugu&'u& c, t t'&s +o&t t'e +a s'ould be ogged at  #&ute &ter.als for 15 #&utes, T&#e Started ,

,


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


Page = of 19 BATCH MANUFACTURING RECORD PRODUCT NAME: FORM: BATCH SIZE: PACKAGING: BOTTLE:

CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




d,

e,

f,

g,

', =

1st Iter.al <d Iter.al rd Iter.al >t' Iter.al T&#e ded (5t' Iter.al) ry t'e tablets for oe 'our %&t' t'e +a sto++ed! t'e eG'aust o! ad a su++ly of cold a&r &troduced &to t'e bed, T&#e Started T&#e ded Total T&#e C'ec* t'e a.erage tablet t'&c*ess ad record t'e#, .e, Tablet T'&c*ess ++ly subse6uet sealcoats us&g t'e sa#e tec'&6ue, ;se t'e sa#e a#out of solut&o as t'e +rocess &s re+eated, 8e#o.e tablets fro# +a ad dedust t'e#,

Has' t'e +a fro# ay trace of sealcoat&g ad allo% to dry,

Subcoat&g


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


Page ? of 19 BATCH MANUFACTURING RECORD PRODUCT NAME: FORM: BATCH SIZE: PACKAGING: BOTTLE:

CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




a,

8etur t'e tablets to t'e +a ad set t'e +a & #ot&o, Tur t'e eG'aust o ad do ot a++ly to t'e tablet bed, b, 8a+&dly %et do% t'e tablets %&t' a++roG&#ately >0 #$ of %ar# subcoat&g solut&o, Volu#e of Solut&o c, St&r t'e tablets %ell by 'ad to s+read t'e l&6u&d o.er t'e tablets as ra+&dly ad u&for#ly as +oss&ble, d, llo% t'e tablets to roll ut&l t'ey s'o% s&gs of be&g tac*y, T&#e Started T&#e ded Total T&#e ;&for#ly dust t'e tablets %&t' subcoat&g +o%der (+re.&ously +assed t'roug' s&e.e o, A0 ut&l t'ey roll freely

e,

llo% t'e tablets to roll for a add&t&oal 15 to <0 #&utes to set subcoat, T&#e Started T&#e ded


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


Page A of 19 BATCH MANUFACTURING RECORD PRODUCT NAME: FORM: BATCH SIZE: PACKAGING: BOTTLE:

CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




f,

g,

',

Total T&#e C'ec* t'e a.erage tablet t'&c*ess ad record t'e#, .e, Tablet T'&c*ess ++ly subse6uet subcoats us&g t'e sa#e tec'&6ue, ;se less solut&o as t'e +rocess &s re+eated (0 #l for t'e secod coat ad <0 #l for t'e succeed&g coats), llo% #ore dry&g t&#e bet%ee coats, <d ++l&cat&o (#$) ry&g T&#e rd ++l&cat&o (#$) ry&g T&#e t' > ++l&cat&o (#$) ry&g T&#e 5t' ++l&cat&o (#$) ry&g T&#e =t' ++l&cat&o (#$) ry&g T&#e

fter subcoat&g! lea.e t'e tablets o.er&g't, o ot a++ly a&r, T'e tablets #ay be +er&od&cally ogged,


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:



CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




?

&,

8e#o.e t'e tablets fro# t'e +a ad dedust t'e#,

,

Has' t'e +a fro# ay traces of subcoat&g solut&o ad allo% to dr y,

/ross&g a,

8etur t'e tablets to t'e +a ad set t'e +a & #ot&o,

b,

Tur t'e eG'aust o t'e a++ly %ar# a&r to t'e tablet bed,

c,

++ly 0 #$ of gross&g solut&o & a t'& steady strea# to %et t'e tablets u&for#ly, Volu#e of Solut&o

d,

St&r t'e tablets %ell by 'ad to s+read t'e l&6u&d o.er t'e tablets as ra+&dly ad u&for#ly as +oss&ble, 1st ++l&cat&o <d ++l&cat&o


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:



CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




rd ++l&cat&o >t' ++l&cat&o 5t' ++l&cat&o =t' a++l&cat&o ?t' ++l&cat&o At' ++l&cat&o e,

llo% t'e tablets to roll %&t' 'ot a&r ad eG'aust o ut&l dust ust beg&s to a++ear & t'e a&r abo.e t'e tablet bed, T&#e Started T&#e ded Total T&#e

f,

C'ec* t'e a.erage tablet t'&c*ess ad record t'e#, .e, Tablet T'&c*ess

g,

++ly subse6uet gross&g syru+ us&g t'e sa#e tec'&6ue Color&g #ater&al ca be added at t'&s stage %&t' cocetrat&o of color cot&ually &creased, T'e #aG&#u# color cocetrat&o s'ould be atta&ed at t'e last stage of

,

',


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:



CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




gross&g, &,

8e+eat t'e +rocess ut&l t'e tablets are reasoably s#oot' ad u&for#ly colored to t'e des&red t&t, 8ecord t'e a#out of FC colorat added, #t, of Color&g Mater&al 7ET T'ere s'ould be o t&#e la+se bet%ee t'e /ross&g stage ad t'e Dea.y Syru+ coat&g +'ase,

A

Dea.y Syru+ Coat&g a

++ly 0 #l of 'ea.y syru+ solut&o & a t'& steady strea# to %et t'e tablets u&for#ly, Volu#e of Dea.y Syru+

b,

St&r t'e tablets %ell by 'ad to s+read t'e l&6u&ds o.er t'e tablets as ra+&dly ad u&for#ly as +oss&ble 1st ++l&cat&o <d ++l&cat&o rd ++l&cat&o


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


Page 1< of 19 BATCH MANUFACTURING RECORD PRODUCT NAME: FORM: BATCH SIZE: PACKAGING: BOTTLE:

CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




>t' ++l&cat&o c,

llo% t'e tablets to roll %&t' 'ot a&r ad eG'aust ut&l dust beg&s to a++ear & t'e a&r abo.e t'e tablet bed, T&#e Started T&#e ded Total T&#e

d,

C'ec* t'e a.erage tablet t'&c*ess ad record t'e#, .e, Tablet T'&c*ess Tur off t'e 'ot a&r co#+letely ad reduce t'e a&r eG'aust of t'e +a,

e,

9

8egular Syru+ Coat&g a

Set t'e +a & #ot&o! tur off 'ot a&r ad reduce eG'aust of t'e +a&,

b

++ly 15 #$ of t'e regular syru+ solut&o & a t'& strea# to %et t'e tablets u&for#ly, Volu#e of 8egular Syru+


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


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CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




c

St&r t'e tablets %ell by 'ad to s+read t'e l&6u&d o.er t'e tablets as ra+&dly ad u&for#ly as +oss&ble, 1st ++l&cat&o <d ++l&cat&o rd ++l&cat&o >t' ++l&cat&o

d

C'ec* t'e a.erage tablet t'&c*ess ad record t'e#, .e, Tablet T'&c*ess

e

8e+eat t'e +rocess ut&l des&red color &s atta&ed,

10 F&&s'&g a,

llo% t'e tablets to roll %&t' eG'aust s'ut off co#+letely,

b,

++ly t'ree to four coats of 15 #l regular


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


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CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




syru+ solut&o ra+&dly %&t'out +er#&tt&g t'e tablet bed to frost or beco#e dusty, 1st ++l&cat&o <d ++l&cat&o rd ++l&cat&o >t' ++l&cat&o

c,

fter t'e a++l&cat&o of t'e last coat! s'ut off +a %'&le tablets are st&ll da#+,

d,

2og t'e +a  of a tur e.ery #&ute for t'e eGt 15 #&utes, T&#e Started <d Iter.al (t&#e) rd Iter.al (t&#e) >t' Iter.al (t&#e) 5t' Iter.al (t&#e) =t' Iter.al (t&#e) ?t' Iter.al (t&#e) At' Iter.al (t&#e)


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:



CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




e,

9t' Iter.al (t&#e) 10t' Iter.al (t&#e) 11t' Iter.al (t&#e) 1t' Iter.al (t&#e) T&#e eded (15t' Iter.al) C'ec* t'e a.erage tablet t'&c*ess ad record t'e#, .e, Tablet T'&c*ess

f,

$ea.e t'e tablets o.er&g't %&t' o eG'aust ad a&r a++l&es to t'e# %&t' l&d closed,

g,

8e#o.e t'e tablets fro# t'e +a ad dedust t'e#,

',

Has' t'e +a fro# ay trace of regular syru+ ad allo% to dry,

11 Pol&s'&g a,

Trasfer t'e tablets to t'e ca.as +ol&s'&g +a,


DATE:


SUPERSEDES:

Prepare/ 4-:

Appro$e/ 4-:

Pro/%,tio!:

Date:

Date:


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BATCH NO.:


FMSI-15I01-01


Time: Date:




b,

llo% t'e tablets to roll %&t' t'e eG'aust s'ut off co#+letely, T&#e Started T&#e ded Total T&#e

c,

++ly 15 #l of +ol&s'&g solut&o & a t'& strea# ad allo% t'e tablets to roll, Vol, of Pol&s'&g SolJ

d,

e,

++ly +ol&s'&g solut&o &##ed&ately ad allo% t'e tablets to roll ut&l t'ey beg& to s'&e, Vol, of Pol&s'&g SolJ T&#e Started T&#e ded Total T&#e ++ly a t'&rd coat of +ol&s'&g solut&o ad allo% t'e tablets to roll ut&l t'e solut&o s+read u&for#ly o.er t'e tablets, Vol, of Pol&s'&g SolJ T&#e Started T&#e ded


DATE:


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Page 1? of 19 BATCH MANUFACTURING RECORD PRODUCT NAME: FORM: BATCH SIZE: PACKAGING: BOTTLE:

CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




Total T&#e ++ly cold a&r to t'e tablet bed ut&l t'e des&red +ol&s' &s ac6u&red, T&#e Started T&#e ded Total T&#e 1< Calculate t'eoret&cal ad actual y&eld, ccout for losses, T'eoret&cal K&eld ctual K&eld f,

STANDARD ACCEPTABLE BULK #IELD L rrage for sa#+le of bul* +roduct to be ta*e by ,C, sa#+ler, cce+ted by AUTHORIZED DE"IATIONS FROM STANDARD PROCEDURE


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Page 1A of 19 BATCH MANUFACTURING RECORD PRODUCT NAME: FORM: BATCH SIZE: PACKAGING: BOTTLE:

CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




PRIOR AUTHORIZATION:

PRODUCTION: 

6A: 

DATE: 

DATE: 

NON;STANDARD E"ENT RECORD (Iclude eG+laat&o of ay o-stadard y&eld)

6UALIT# CONTROL APPRO"AL FOR PACKAGING


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CAP:


BATCH NO.:


FMSI-15I01-01


Time: Date:




T'&s bul* batc' of BBBBBBBBBBBBBBBBBBBBBBBBBBB atc' 7o BBBBBBBBBBBBBB 'as bee sa#+led ad tested! ad &s released for +ac*ag&g, S&ged BBBBBBBBBBBBBBB ! ual&ty Cotrol ate BBBBBBBBBBBBBBBBBBBBBBBBBBBBB

PRODUCTION CERTIFICATION +art fro# ay aut'or&3ed de.&at&os! or o-stadard e.ets! as recorded abo.e! t'&s batc' 'as bee #aufactured & accordace %&t' t'&s TCD M7;FCT;8I7/ FE8M;$! MTDE! ad 8CE8, S&ged BBBBBBBBB ! Product&o Su+er.&sor ate BBBBBBBBBBBBBBBBBBBBBBBBBBBBB


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BMR Sugar Coated Placebo Tablets

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