Design Qualification protocol of AHUDescrição completa
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Autoclave is used for wet sterilization of various items
Product Design Analysis
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Product design, also known as industrial design, combines the knowledge of design, engineering, and manufacturing processes to create functional products. It may contain tests in order to determine whether their products meet all requirements, and th
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Authors: A. K. CHITALE, R. C. GUPTA PHI Learning Private Limited
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BF Biosciences Limited
VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
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DESIGN QUALIFICATION
Name "!itten B#$
At%o!i*ed B#$
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E#ectro!ic$ Tech!icia!
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Lead Leade! e! Te Tec%ni c%nica ca&& Va&i Va&ida dati tion on G!o' a) M&haa' Tahir ("a#
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DQ
Co!' Co!'o! o!at ate e Va&ida &idatio tion n G! G!o o' '
Dr.,a# Na$ir
Director Tech!ica#
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DQ
INSTRUCTIONS FOR DOCUMENTATION COM+LETION
## +erforer$ a!' reviewer$ &$t co+#ete &a#ificatio! for$ &$i!g the fo##owi!g g&i'e#i!e$: Co+#ete a## ite$ o! a for i! f&##4 e5ce+t the o+tio!a# coe!t6$ $ectio!. Doc&e!t a!2 'eviatio! fro 'efi!e' +rotoco#$ a!' acce+te' re$&#t$. *w!er a++rova# of +rotoco# 'eviatio!$ &$t "e 'oc&e!te' "efore fi!a# a++rova# $ig!at&re$ ca! "e o"tai!e'. 7rite a''itio!a# coe!t$ o! a! a''e!'& $heet whe! there i$ !ot e!o&gh $+ace o! a for to accoo'ate a## coe!t$. 0$e the$e three $te+$ whe! a''i!g a! a''e!'& $heet. 1.
N&"er the +age a#+ha!&erica##2.
3.
(!itia# a!' 'ate a''itio!$.
.
(!$ert the a''e!'& $heet "ehi!' the origi!a# +age.
Ma9e a## e!trie$ i! +era!e!t "#ac9 or "#&e "a## +e!.
CORRECTING ENTRIES (f 2o& !ee' to a9e correctio!$ o! a for4 &$e the +roce'&re$ 'e$cri"e' "e#ow:
CORRECTING SHORT ENTRIES To correct a $hort e!tr2 $&ch a$ a $i!g#e wor' or te$t re$&#t; o! a for: 1.
Draw a 'iago!a# #i!e4 "otto #eft to &++er right4 thro&gh the i$$ e!tere' or i!correct i!foratio!.
3.
7rite the correctio! to the &++er right of the origi!a# e!tr2.
.
=.
(!itia# a!' 'ate the cha!ge.
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DQ
INSTRUCTIONS FOR DOCUMENTATION COM+LETION
CORRECTING LONG ENTRIES To correct a #o!g e!tr2 or i!foratio! "#oc9 o! a for: 1.
Draw a 'iago!a# #i!e4 "otto #eft to &++er right4 thro&gh the i$$ e!tere' or i!correct i!foratio!.
3.
7rite the correctio! o! a $e+arate a''e!'& +age.
.
=.
(!itia# a!' 'ate the cha!ge$.
>.
N&"er the +age a#+ha!&erica##2
?.
P#ace the a''e!'& +age "ehi!' the origi!a# +age.
MAR,ING ELEMENTS THAT ARE NOT A++LICABLE Mar9 each e#ee!t caref&##2 accor'i!g to the i!$tr&e!t$ "e#ow4 $o that it wi## "e c#ear that the e#ee!t i$ &!!ece$$ar2 a!' that 2o& have !ot $9i++e' or forgotte! the e#ee!t. 1.
Draw a 'iago!a# #i!e4 "otto #eft to &++er right cor!er4 thro&gh the e#ee!t that i$ !ot re&ire'.
3.
7rite the #etter$ N Not ++#ica"#e;4 2o&r i!itia#$4 a!' the 'ate a"ove the #i!e. (!c#&'e coe!t$ a"ove the #i!e or o! the for to 'oc&e!t the rea$o! the e#ee!t i$ !ot re&ire'.
The +erforer a!' reviewer &$t $ig! a!' 'ate a## for$4 a$ &$&a#4 eve! whe! +art or a## of the for i$ ar9e' @NA. N OTE : ALL ORIGINAL ENTRIES MUST REMAIN LEGIBLE AFTER ANY CORRECTIONS HAVE BEEN MADE .
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INSTRUCTIONS FOR DOCUMENTATION COM+LETION
CAUTION The fo##owi!g co!'itio!$ re&ire @re-&a#ificatio!AB 7he! a (!$tr&e!t o'ificatio! ha$ "ee! co+#ete'4 it affect$ the i!$ta##atio! &a#ificatio!. 7he! the $oftware or firware ha$ "ee! &+gra'e' or cha!ge' 7he! thi$ (!$tr&e!t i$ "ei!g reove' fro where it wa$ origi!a##2 i!$ta##e'.
RE-CALIBRATION . RE-CERTIFICATION REQUIREMENTS The fo##owi!g co!'itio!$ re&ire @re-ca#i"ratio! re-certificatio!B or a +re-'eteri!e' +erio' of tie or &$e. fter a!2 i!or $ervice ha$ "ee! 'o!e or re+#acee!t or +art$. 7he! thi$ (!$tr&e!t i$ "ei!g reove' fro where it wa$ origi!a##2 i!$ta##e'.
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TABLE OF CONTENT /ectio!
De$cri+tio!
Page No.
1.
3.
De$ig! Q&a#ificatio! Protoco# ++rova#
=
.
(!tro'&ctio!
>
=.
*",ective
>
>.
/co+e
>
?.
cce+ta!ce Criteria
>
.
Proce'&re
>
ttache!t
8.
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Section /01 Int!odction$ De$ig! &a#ificatio! i$ the 'oc&e!te' evi'e!ce that the $2$te ha$ "ee! 'e$ig!e' correct#2 a$ +er 0R/ a!' goo' e!gi!eeri!g +ractice$. Thi$ De$ig! Q&a#ificatio! +rotoco# i$ &$e' to verif2 the De$ig! of e&i+e!t $2$te+ro,ect !ae; $2$te a$ +er 0R/4 #ocate' i! F Fio$cie!ce$ #t'
Section 201 O34ecti(e$ The o",ective of thi$ +rotoco# i$ to e$ta"#i$h the 'oc&e!te' evi'e!ce that a## 9e2 a$+ect$ of the $2$te are i! co+#ia!ce with agree' $+ecificatio!$ a!' a## fa"ricatio! a!' a!&fact&ri!g wi## "e 'o!e to eet the re&ire' $+ecificatio!$ e!tio!e' i! the 0R/.
Section 501 Sco'e$ The $co+e of thi$ +roce'&re i$ to eva#&ate the fo##owi!g "&t !ot #iite' to the$e: De$ig! of (!$tr&e!te&i+e!t/2$te a$ +er re&iree!t$. ## re#eva!t 'oc&e!t$ are $&++#ie' with 'e$ig! Note: De$ig! &a#ificatio! i$ #iite' to the 'e$ig! of $2$te co+o!e!t$ a!' attache' co+o!e!t$ a!' 'oe$ !ot i!c#&'e De$ig! of a!2 $&++ort &ti#itie$4 other tha! co!!ectio!$ at the $2$te "o&!'ar2.
i!i$h
/tore /ie :?GGGH=GGGH=>GG ? I+ $ei heretic ir coo#e' Co!'e!$i!g &!it /&ita"#e for ai!tai! te+:-J 3KC L J 8C Door $ie :GGH1GGH1GGthic9) #oori!g $i!g#e #a2er of >G P.0.Foar' E#ectric +a!e# are $ho&#' "e a$ +er 'rawi!g
Section ;01 Acce'tance C!ite!ia The acce+ta!ce criteria wi## 'e+e!'$ o! the certificatio! that the De$ig! of the roo i$ i! co+#ia!ce with the re&iree!t$ of thi$ +rotoco# a$ i!i& or e5cee'$ the re&iree!t$).
Section 901 +!oced!e The 'e$ig! of e&i+e!ti!$tr&e!t$2$te wi## "e &a#ifie' "2 'e$ig!e' ca#c&#atio!$4 eva#&atio! thro&gh 0R/ a!' co!firatio! of that the 'e$ig! co!fir$ to e$ta"#i$h $+ecificatio!$ a!' 'oc&e!t$. (f there i$ a!2 'eviatio! i$ o"$erve' wi## "e re+orte' o! the 'eviatio! for. The 9e2 $+ec$ of DQ are a$ fo##ow$:
<0/ De(e&o'ment o= URS$ /+ecificatio!$ re&iree!t$ of the &$er gro&+ wi## e$ta"#i$h the criteria of 0R/ for the e&i+e!ti!$tr&e!t$2$te. The re&iree!t$ $+ecificatio!$ of &$er gro&+ are a$: .1.1
Re&iree!t$ of Ooca# Reg&#ator2 M*I)
.1.3
Re&iree!t$ of Q&a#it2
.1.
Re&iree!t$ of E!gi!eeri!g
.1.=
.3
De$ig! Frief The co!$&#ta!t ve!'or$&++#ier wi## 'e$ig! +rovi' e the e&i+e!ti!$tr&e!t$2$te o! the "a$i$ of 0R/ a!' 'rawi!g #a2o&t +rovi'e' a!' wi## $&"it the 'e$ig! for a++rova#. o##owi!g$ are the 9e2 $te+$
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accor'i!g to which the co!$&#ta!t $&++#ier wi## $&"it the 'e$ig! $+ec$ for review a!' a++rova#. <020/ <0202 <0205
De$cri+tio!. /+ecificatio!$. Drawi!g #a2o&t.
7.3 Design Re(ie)$
The co!$&#ta!t ve!'or wi## $&"it the 'e$ig! for review. fter the review a!' a++rova# of 'e$ig!4 the co!$&#ta!t ve!'or wi## +rovi'e the fo##owi!g 'etai#$: i!a# 'rawi!g$ #a2o&t$ $+ecificatio!$
<06 Design Smma!# Re'o!t$ The De$ig! /&ar2 Re+ort wi## "e ge!erate' after the &a#if2i!g the De$ig! of i!i$h Pro'&ct co#' Roo.
<09 De(iation Re'o!t$
(f a!2 'eviatio! i$ o"$erve'4 wi## "e recor'e' i! the 'eviatio! re+ort $ee !!e5&re ). The corrective actio! wi## a#$o "e recoe!'e' i! the 'eviatio! re+ort.
