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Master Production Record vs

Batch Production Record

http://www.pharmweb.net/forum/0068/2005/msg00046.html

I've attached 21 CFR 211.186 "Master production and control records" and

211.188 "Batch production and control records" belo so that !ou can revie

the F# re$uire%ents verbati%.

Man! or&aniations re(er to the photocop! o( the Master )roduction and

Control Record *M)CR+ as the "batch record" even thou&h this is strictl! not

the case. ,hile the Batch )roduction and Control Record *B)CR+ does include

a photocop! o( the M)CR- it also includes %an! other thin&s- such as

laborator! results- line clearin& reports- e$uip%ent cleanin& lo&s

reports- labelin& in(o- etc.

I( !ou are atte%ptin& to strea%line !our batch record or/(lo- andparticularl! i( !our tr!in& to ri&orousl! %odel and or auto%ate it- !ou

ill $uic/l! encounter the parado0 o( callin& ever!thin& the "batch record."

*.&. Fro% a data entit! data %odelin& standpoint- ho do !ou discri%inate

beteen the ra photocop!- the lotnu%bered photocop!- the photocop!

inscribed ith data- and the %anila (older holdin& the photocop! and all o(

the other ite%s3+

,e have (ound it use(ul to use the ter% "ispatch )roduction and Control

Record" *)CR or "dispatch record"+ to re(er to the lotnu%bered- speci(ic

photocop! o( the M)CR that ill beco%e a part o( the B)CR. In or/(lo

%odelin& ter%s- the )CR is an output o( the 4chedulin& process- a data

ele%ent o( the )roduction process- and a "child" data ele%ent o( the

"parent" B)CR.

I hope !ou (ind this use(ul.

4incerel!-

5ho%as uinn- CI44)- ###

)resident- 5he 7ollis roup- Inc.

t$uinn9hollis&roup.co%

.hollis&roup.co%

v: 61;88?; (: 61;2>+ # co%plete list o( co%ponents desi&nated b! na%es or codes su((icientl!

speci(ic to indicate an! special $ualit! characteristic

*A+ #n accurate state%ent o( the ei&ht or %easure o( each co%ponent- usin&

the sa%e ei&ht s!ste% *%etric- avoirdupois- or apothecar!+ (or each

co%ponent. Reasonable variations %a! be per%itted- hoever- in the a%ount o(

co%ponents necessar! (or the preparation in the dosa&e (or%- provided the!

are usti(ied in the %aster production and control records

*?+ # state%ent concernin& an! calculated e0cess o( co%ponent

*6+ # state%ent o( theoretical ei&ht or %easure at appropriate phases o(

processin&

*=+ # state%ent o( theoretical !ield- includin& the %a0i%u% and %ini%u%

percenta&es o( theoretical !ield be!ond hich investi&ation accordin& to

211.1

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*A+ ,ei&hts and %easures o( co%ponents used in the course o( processin&

*?+ Inprocess and laborator! control results

*6+ Inspection o( the pac/a&in& and labelin& area be(ore and a(ter use

*=+ # state%ent o( the actual !ield and a state%ent o( the percenta&e o(

theoretical !ield at appropriate phases o( processin&

*8+ Co%plete labelin& control records- includin& speci%ens or copies o( all

labelin& used

*A.

#n additional co%%ent. I didn't see the ori&inal $uestion and don't ish to

en&a&e in se%antics. 7oever- dependin& on !our production process it %a! be

convenient to have several unitar! operations (or hich !ou %a! ant to have

several B)R. I( !ou (ind !ou have to add %an! anne0 docu%ents to each B)R

!ou should criticall! evaluate hether its ori&inal MB)R docu%ent is (ull!

co%plete or relevant. Finall!- to discri%inate beteen all the di((erent

docu%ents that need to be included I ould call the dispatch record%entioned belo a *uni$uel! nu%bered+ )roduction ossier hich hen co%plete

should include :

DI( appropriate- a cop! o( the relevant )rocessin& Instruction*s+ and sop*s+

Dco%pleted B)R *there %a! be %ore than one i( the process co%prises several

unitar! steps+

Dall supportin& (or%s or record or e$uivalent ith re&istered data etc

Da report on the batch

5here ill be an e$uivalent Control ossier (or the C testin& part.

4tephen Bron

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MBR and BPR Defined

http://www.instantgmp.com/blog/mbr-and-bpr-definedPosted on May 19, 2014by Kelly Waters

All c!P manufacturers are re"u#red to $eep !aster %atch

&ecords '!%&s( and %atch Product#on &ecords '%P&s( #n order

to comply w#th )*A regulat#ons.

Master Batch Records+ also $nown as !aster

!anufactur#ng )ormulas+ are general manufactur#ng#nstruct#ons. ,ach un#"ue formulat#on must ha-e #ts own !%&

and should #nclude:

dent#cat#on of product name.

%#ll of !ater#als+ deta#l#ng the we#ght+ measure or count

of each component needed to manufacture the batch.

,"u#pment l#st.

omponent l#st. 1tatement of theoret#cal y#eld at each step #n the

manufactur#ng process.

,pected y#eld of the n#shed product.

1pec#c #nstruct#ons for each state #n the manufactur#ng

process.

1ampl#ng and test#ng procedures.

nstruct#ons for manual operat#ons.

3he purpose of an !%& #s to ensure that all proper

#ngred#ents are added and that each step #n the process #s

completed.

Batch Production Recordsare cop#es of the !aster %atch

&ecord. 3he %P& documents the when+ how+ by whom+ w#th

http://www.instantgmp.com/blog/mbr-and-bpr-definedhttp://www.instantgmp.com/2014/05/19http://www.instantgmp.com/author/kwatershttp://www.instantgmp.com/blog/mbr-and-bpr-definedhttp://www.instantgmp.com/2014/05/19http://www.instantgmp.com/author/kwaters

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what tools and #n what en-#ronment a product was

produced.3he %atch &ecord #s where operators record spec#c

lot numbers as well as the spec#c we#ghts+ measure or count

of #ngred#ents and components actually used to produce that

spec#c batch.

h#le the !aster %atch &ecord ser-es as a template for the

manufactur#ng process+ the purpose of a %P& #s to show that

each spec#c batch of product was created #n accordance to

the !%& and also epla#n all de-#at#ons that may ha-e

occurred dur#ng product#on of any g#-en batch. 3he %atch

&ecord ser-#ces as a controlled record of the process #n order

to ma#nta#n traceab#l#ty of raw #ngred#ents and manufactur#ngpract#ces.