Quality Assurance

Quality Assurance

&
&
Quality Control
Quality Control
In Pharma
In Pharma
Industry
Industry
Dr. Basavaraj K. Nanjwade
Dr. Basavaraj K. Nanjwade
M.Pharm., Ph. D M.Pharm., Ph. D
Associate Professor of Pharmaceutics Associate Professor of Pharmaceutics
Department of Pharmaceutics Department of Pharmaceutics
KLE University, Be!aum " #$%%&%, Karnata'a, (ND(A KLE University, Be!aum " #$%%&%, Karnata'a, (ND(A
E)mai* E)mai* +'nanjwade,yahoo.co.in +'nanjwade,yahoo.co.in
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QC
GMP
QA

(t is the sum tota of the
or!ani2ed arran!ements
with the o+jective of
ensurin! that products
wi +e of the 3uaity
re3uired for their
intended use
QA

(s that part of 4uaity
Assurance aimed at
ensurin! that products
are consistenty
manufactured to a
3uaity appropriate to
their intended use
GMP

(s that part of 56P
concerned with sampin!,
specification 7 testin!,
documentation 7 reease
procedures which ensure
that the necessary 7
reevant tests are
performed 7 the product is
reeased for use ony after
ascertainin! it8s 3uaity
QC

QA
QA
and
and
QC
QC
9 4- is that part of 56P
which is concerned with
sampin!,
specifications, testin!
and with in the
or!ani2ation,
documentation,and
reease procedures
which ensure that the
necessary and reevant
tests are carried out
9 4A is the sum tota of
or!ani2ed
arran!ements made
with the o+ject of
ensurin! that product
wi +e of the 4uaity
re3uired +y their
intended use.

QA
QA
and
and
QC
QC
9 :perationa
a+oratory
techni3ues and
activities used to
fufi the
re3uirement of
4uaity
9 A those panned
or systematic
actions necessary
to provide
ade3uate
confidence that a
product wi satisfy
the re3uirements
for 3uaity

QA
QA
and
and
QC
QC
9 4- is a+ +ased 9 4A is company
+ased

Determine impurity level in
relevant batches
1
Acceptance criterion = A or
B
(as appropriate)
Is
impurity also
a
degradation
product?
Is
A or B
greater than the
qualified
level?
Acceptance criterion = qualified
level
or establish ne qualified level
!
"stimate ma#imum increase in impurity
at retest date using data from relevant
accelerated and long$term stability
studies
Determine ma#imum li%ely level as&
A ' increase in degradation product at
appropriate storage conditions(
()et this = B)
*"+
*"+
,-
,-
ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A
NEW
DRUG SUBSTANCE
1
.elevant batches are those from development/ pilot and scale$up studies(
!
.efer to I01 2uideline on Impurities in ,e Drug +ubstances
Definition& upper confidence limit = three times the standard deviation of batch analysis data
Determine mean ' upper
confidence
limit for the impurity ()et this = A)

Does
degradation
occur during product
manufacture?
"stimate ma#imum increase in
degradation product at shelf life using
data from relevant accelerated and
long$term stability studies(
()et this = D)
Determine ma#imum li%ely level as
drug substance acceptance criterion
!
(
((A or B)

' 0 ' D)
Is
ma#imum
li%ely level greater
than the
qualified
level?
"stimate ma#imum increase in degradation
product during manufacture from relevant
batches
1
( ()et this = 0)
Acceptance criterion = ma#imum li%ely level(
Acceptance criterion = qualified
level
or establish ne qualified level
3
or ne storage conditions
or reduce shelf life(
,-
,-
*"+
*"+
ESTABLISHING ACCEPTANCE CRITERION FOR A DEGRADATION PRODUCT IN A
NEW DRUG PRODUCT
1
.elevant batches are those from development/ pilot and scale$up studies(
!
.efer to Decision 4ree 1 for information regarding A and B(
3
.efer to I01 2uideline on Impurities in ,e Drug 5roducts(

Is the drug product a solid
dosage form or liquid
containing undissolved
drug substance?
,o drug substance particle
si6e acceptance criterion
required for solution dosage
forms(
1( Is the particle si6e critical to dissolution/
solubility/ or bioavailability?
!( Is the particle si6e critical to drug product
processability?
3( Is the particle si6e critical to drug product stability?
7( Is the particle si6e critical to drug product
content uniformity?
8( Is particle si6e critical for maintaining
product appearance?
+et Acceptance 0riterion
,o Acceptance 0riterion
.equired
If *"+ to any
If ,- to all
,-
*"+
SETTING ACCEPTANCE CRITERIA FOR DRUG SUBSTANCE PARTICLE SIZE
DISTRIBUTION

INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA FOR
POLYMORPHISM
IN DRUG SUBSTANCES AND DRUG PRODUCTS
Drug +ubstance
1(
!(
,-
*"+
0onduct polymorphism
screen on drug substance(
,o further action
0an
different polymorphs
be formed?
2- 4-
0haracteri6e the forms&
e(g(/ $ 9$ray 5oder
Diffraction
$ D+0 :
4hermoanalysis
$ ;icroscopy
$ +pectroscopy

INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA FOR
POLYMORPHISM
IN DRUG SUBSTANCES AND DRUG PRODUCTS
!(
3(
2- 4-
,-
,-
*"+
Do the
forms have
different properties?
(solubility/ stability/
melting point)
Is drug
product safety/
performance or
efficacy affected?
,o further test or
acceptance criterion
for drug substance
*"+
+et acceptance criterion
for polymorph content
in drug substance

INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA FOR
POLYMORPHISM
IN DRUG SUBSTANCES AND DRUG PRODUCTS
3(
*"+
,-
,-
*"+
Does
drug product
performance testing
provide adequate control if
polymorph ratio changes
(e(g(/ dissolution)?
"stablish acceptance criteria
for the relevant performance
test(s)(
;onitor polymorph form during
stability of drug product(
,o need to set acceptance criteria
for polymorph change in drug
product(
Does a
change occur
hich could
affect
safety or
efficacy?
"stablish acceptance criteria
hich are consistent ith
safety and:or efficacy(
Drug 5roduct $ +olid Dosage <orm or )iquid 0ontaining =ndissolved Drug +ubstance
=nderta%e the folloing processes only if technically possible
to measure polymorph content in the drug product(

ESTABLISHING IDENTITY, ASSAY AND ENANTIOMERIC IMPURITY PROCEDURES
FOR CHIRAL NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS CONTAINING
CHIRAL DRUG SUBSTANCES
*"+
A,D .A0";I0
0onsider the need for
verifying chiral identity in
drug substance release
and:or acceptance
testing(
Is the ne
drug substance
chiral
1
?
0hiral identity/ assay
and impurity
procedures
are not needed(
*"+
A,D -," ",A,4I-;".
,eeded for drug substance specification&
!

$chiral identity
3
$chiral assay
7
$enantiomeric impurity
8
,eeded for drug product specification
>
&
$chiral assay
7
$enantiomeric impurity
8

,-
1
0hiral substances of natural origin are not addressed in this 2uideline(
!
As ith other impurities arising in and from ra materials used in drug substance synthesis/ control of chiral quality could be established alternatively
by applying limits to appropriate starting materials or intermediates hen ?ustified from developmental studies( 4his essentially ill be the case hen
there are multiple chiral centers (e(g(/ three or more)/ or hen control at a step prior to production of the final drug substance is desirable(
3
A chiral assay or an enantiomeric impurity procedure may be acceptable in lieu of a chiral identity procedure(
7
An achiral assay combined ith a method for controlling the opposite enantiomer is acceptable in lieu of a chiral assay(
8
4he level of the opposite enantiomer of the drug substance may be derived from chiral assay data or from a separate procedure(
>
+tereospecific testing of drug product may not be necessary if racemi6ation has been demonstrated to be insignificant during drug product
manufacture and during storage of the finished dosage form(

MICROBIOLOGICAL QUALITY ATTRIBUTES OF DRUGS MICROBIOLOGICAL QUALITY ATTRIBUTES OF DRUGS
SUBSTANCE AND EXCIPIENTS SUBSTANCE AND EXCIPIENTS
(s the dru! su+stances;e<cipient
-apa+e of supportin! micro+ia
5rowth or via+iity
(s the dru! su+stances;e<cipient
=terie>
Does dru!
su+stances;e<cipient
=ynthesis;processin! invove
=teps which inherenty
?educe microor!anisms>
Esta+ish micro+ia imit acceptance
-riteria
As per the harmoni2ed pharmacopoeia
mono!raph
Are monitorin!
6icroor!anism;indicator eves
-onsistenty +eow acceptance criteria
Leves>
@est ots on a s'ip)ot +asis for
6icro+ia imits and freedom from
-ompendia indicator or!anisms.
@est each ot for micro+ia imits
and freedom from compendia
indicator or!anisms.
Provide supportin! data. 6icro+ia
Limits acceptance criteria and
testin!
6ay not +e necessary
No further micro+ia imits testin! or
Acceptance criteria are necessary
Esta+ish micro+ia imit acceptance
criteria
As per the harmoni2ed pharmacopeia
mono!raph
Does scientific evidence demonstrate that
?education steps resut in microor!anism eves
Aacceptance criteria imits Band the a+sence of
-ompendia indicator or!anismsC
(n the dru! su+stance;e<cipient>
Provide supportin! data.
6icro+ia imits acceptace
-riteria and testin!
6ay not +e necessary
DE=
DE=
DE=
DE=
DE= N:
N:
N:
N:
N:

1
(
@hat type of drug release acceptance criteria are appropriate?
Is the dosage
form designed to produce
modified release?
*"+
"stablish drug release acceptance criteria(
"#tended release& multiple time points
Delayed release& to stages/ parallel
or sequential
Is drug solubility
at 3A B C(8D0 high throughout
the physiological p1 range?
(Dose: solubility E !8C m)
(p1 1(! $ >(F))
,-
0ontinued on ne#t page(
2enerally single$point dissolution
acceptance criteria ith a loer limit
are acceptable(
Is dosage form
dissolution rapid?
(Dissolution G FCH in 18 minutes
at p1 1(!/ 7(C/ and >(F)
1as a relationship been
determined beteen disintegration
and dissolution?
2enerally disintegration acceptance
criteria ith an upper time
limit are acceptable(
*"+
,-
*"+
*"+
,-
,-
SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT DISSOLUTION

!( @hat specific test conditions and acceptance criteria are appropriate? Iimmediate releaseJ
Does
dissolution significantly
affect bioavailability?
(e(g(/ have relevant developmental
batches e#hibited unacceptable
bioavailability?)
Attempt to develop test conditions and acceptance
criteria hich can distinguish batches
ith unacceptable bioavailability(
*"+
,-
*"+
,-
*"+
,-
Do changes in
formulation or
manufacturing variables
affect dissolution?
(=se appropriate ranges(
"valuate dissolution
ithin p1 1(! $ >(F)
Are these changes controlled
by another procedure and acceptance
criterion?
Adopt appropriate test conditions
and acceptance criteria ithout
regard to discriminating poer/ to
pass clinically acceptable batches(
Adopt test conditions and acceptance criteria
hich can distinguish these changes(
2enerally/ single point acceptance criteria
are acceptable(
SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT DISSOLUTION

3(
*"+
,-
,-
*"+
*"+
,-
*"+
,-
Are bioavailability
data available for batches
ith different drug release rates?
Is drug release independent of
in vitro test conditions?
0an an in vitro / in vivo
relationship be established?
(;odify in vitro test
conditions
if appropriate()
=se all available stability/ clinical/ and
bioavailability data to establish
appropriate acceptance ranges(
=se the in vitro / in vivo
correlation/ along ith
appropriate batch data/ to
establish acceptance ranges(
Are acceptance
ranges G!CH of the
labeled content?
5rovide appropriate
bioavailability data
to validate the
acceptance ranges(
<inali6e acceptance
ranges(
SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT DISSOLUTION
@hat are appropriate acceptance ranges? Ie#tended releaseJ

MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE
DRUGS PRODUCTS DRUGS PRODUCTS
Does the dru! product contain
Antimicro+ia preservatives or possess
(nherent antimicro+ia
activity
(s the dru! product a dry dosa!e form
Be.!. soid ora or dry powderC>
Does scientific evidence demonstrate
5rowth inhi+itory properties of the
Dru! product>
6icro+ia imits acceptance criteria and testin!
6ay not +e necessary
Esta+ish preservative chemica acceptance criteria and
Perform preservative effectiveness vaidation of product
-ontainin! ess than or e3ua to the minimum specifie
Preservative concentration, or demonstrate the inherent
Antimicro+ia activity of the dru! product.
Esta+ish micro+ia imit acceptance criteria
As per the harmoni2ed pharmacopoeia
6ono!raph.
Perform micro+ia imits testin! on a
Lot)+y)ot +asis.
Do production ots consistenty meet
6icro+ia imits acceptance criteria>
Perform s'ip)ot testin! for micro+ia
Limits, or provide scientific justification for
no routine micro+ia imits testin!.
No
No
No
No
DE=
DE=
DE=
DE=

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Quality Assurance (QA) Management
Procedure

H!/ (! /r#(% S(a"&ar& O'%ra(#"-
H!/ (! /r#(% S(a"&ar& O'%ra(#"-
Pr!0%&)r%
Pr!0%&)r%
9 =:P descri+es standard =:P format
that you can use immediatey for
your 3uaity procedure.
9 =:P has instructions on how to write
a forma operatin! procedure for
your systems which your peope can
foow everyday.

A** D!0)m%"($C*a$$#.#0a(#!"$,
A** D!0)m%"($C*a$$#.#0a(#!"$,
D%.#"#(#!" a"& A''r!4a* Ma(r#3
D%.#"#(#!" a"& A''r!4a* Ma(r#3
9 (n this =:P you wi find a type of 3uaity
and @echnica;6aster fie documents to
+uid up a !ood 3uaity mana!ement
system for your manufacturin! sites,
definition of documents, their
cassification, approva re3uirements and
retention re3uirements.
9 @his procedure has schematic dia!rams for
your understandin! of how different types
of documents are prepared and stored in a
typica documentation.

Q)a*#(, D!0)m%"(a(#!" Ma"a-%m%"(
Q)a*#(, D!0)m%"(a(#!" Ma"a-%m%"(
a"& Cha"-% C!"(r!*
a"& Cha"-% C!"(r!*
9 @his =:P descri+es how to !enerate new
3uaity documents or chan!e contro of
e<istin! documents, review of 3uaity
documents, sateite fie mana!ement, roe
of document author, approver, document
contro officer and sateite fie
administrator.
9 (n this =:P you wi aso find num+erin!
systems of different 3uaity documents i'e
audit fies, =:P8s, forms, manuas, trainin!
fies, 4A a!reements, project fies etc and
their effective archivin! system.

D!0)m%"(a(#!" R)*% .!r GMP
D!0)m%"(a(#!" R)*% .!r GMP
D!0)m%"($
D!0)m%"($
9 @his =:P descri+es the principes to
+e foowed in 56P documents, entry
of data and information, si!nature
re3uirements and correction
techni3ue of incorrecty entered data
or information.

Q)a*#(, D!0)m%"(a(#!"C!"(r!*,
Q)a*#(, D!0)m%"(a(#!"C!"(r!*,
Tra02#"- a"& D#$(r#+)(#!"
Tra02#"- a"& D#$(r#+)(#!"
9 (n this =:P you wi find mainy the roe of document
contro officer durin! the initiation, creation,
circuation and approva of new 3uaity reated
documents.
9 (t aso descri+es the procedure of modification and
review of e<istin! document usin! a documentation
data+ase.
9 6ana!ement of e<istin! and superseded documents
is aso a art of this procedure.
9 Dou wi see a the forms referred durin! the
instruction are attached at the end of the procedure.

Pr%'ara(#!", Ma#"(%"a"0% a"&
Pr%'ara(#!", Ma#"(%"a"0% a"&
Cha"-% C!"(r!* !. Ma$(%r D!0)m%"($
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9 @his =:P particuary focused on the mana!ement
of master fie documents i'e specifications,
contro methods, raw materias, finished !oods
and pac'a!in! specification and test reports,
formuation, sta+iity fies etc re3uired to !enerate
durin! the product re!istration in the mar'et.
9 @his =:P !ives instruction on their creation,
chan!e contro, num+erin! system, approva
re3uirements and maintenance in a simpe master
fie data+ase.
9 Dou wi see a the forms referred durin! the
instruction are attached at the end of the
procedure.

D%4#a(#!" R%'!r( S,$(%m
D%4#a(#!" R%'!r( S,$(%m
9 (t is a re!uatory re3uirement to capture a sorts
of deviations evoves in your systems in order to
maintain the continuous improvement to your
processes and systems.
9 @his =:P descri+es how to cate!ori2e the
deviations +etween production, audit, 3uaity
improvements, technica deviations, customer
compaints and environmenta, heath and safety
deviations.
9 (t descri+es the mana!ement responsi+iities of
initiatin! deviation, capture data, anaysis,
investi!ation, determination of assi!na+e causes,
!eneration of mana!ement report and initiatives to
+e ta'en on corrective and preventative actions.

Sh%*. L#.% !. Pr!&)0(
Sh%*. L#.% !. Pr!&)0(
9 @his simpe =:P descri+es the
meanin! of shef ife and provides on
how to interpret shef ives and
stora!e conditions for your raw
materias from the -ertificate of
Anaysis, determinin! e<piry date for
your finished products +y use of raw
materia date of manufacturin! and
their shef ives.

V%"&!r S%*%0(#!" a"& E4a*)a(#!"
V%"&!r S%*%0(#!" a"& E4a*)a(#!"
9 @his =:P descri+es the procedure to +e
foowed durin! the vendor assessment
and vendor evauation for purchasin! of
raw materias, critica and non critica
pac'a!in! components, a+oratory
suppies, en!ineerin! suppies and
imported finished !oods from the vendor.
9 @hese instructions are essentia for
approvin! prospective vendor.

V%"&!r C%r(#.#0a(#!"
V%"&!r C%r(#.#0a(#!"
9 @his procedure aim to descri+e the process
+y which a vendor may +e certified to
suppy materias or services.
9 @his procedure appies to vendors that
suppy a materia or service to +e used at
any sta!e of manufacture +y operations.
9 Eere you wi !et the roes of each
department in the process to certify an
approved vendor.

Pr!&)0( C!m'*a#"( Pr!0%&)r%
Pr!&)0( C!m'*a#"( Pr!0%&)r%
9 @his procedure covers the receipt, o!!in!,
evauation, investi!ation and reportin! system of
a compaints received from customers for the
mar'eted products.
9 @his =:P contains step +y step instruction to +e
foowed in the customer compaint mana!ement
i'e num+erin! of compaint, re!istration,
evauation of compaints, determination of
assi!na+e cause for the compaint deviation,
impementation of corrective and preventive
actions, trendin! of compaints and handin! of
counterfeit products.

A"")a* Pr!&)0( R%4#%/
A"")a* Pr!&)0( R%4#%/
9 @his procedure provides a !uideine
to annua product review which is
re3uired to +e performed for each
product produced for the commercia
mar'et to evauate data, trends and
to identify any preventative or
corrective action that woud ead to
product 3uaity improvements and
report them to mana!ement.

R%/!r2 Pr!0%&)r%
R%/!r2 Pr!0%&)r%
9 @his =:P contains the step +y step instruction to
+e foowed when the rewor' of an in)process or
competed finished !ood is re3uired.
9 @his =:P covers the rewor's of in)process
manufactured !oods where new +atch num+er is
introduced for the rewor'ed part and rewor' of
manufactured finished !ood 'eepin! the same
+atch num+er.
9 @his =:P aso descri+es how to create rewor'
protocos for each individua case.

A)(h!r#7%& P%r$!"
A)(h!r#7%& P%r$!"
9 @his simpe procedure descri+es the
accreditation, accounta+iities and
responsi+iities of an Authori2ed
person, responsi+e for reease of
finished !oods for sae.

Pr!&)0( I&%"(#.#0a(#!" a"&
Pr!&)0( I&%"(#.#0a(#!" a"&
Tra0%a+#*#(,
Tra0%a+#*#(,
9 @he purpose of this =:P is to define the
method used for the identification of a
contri+utin! materias that coud affect
product 3uaity and to ensure their fu
tracea+iity.
9 Eere you wi find instruction on a the
records and documents used for the
identification and tracea+iity of incomin!
raw materias and out !oin! finished
!oods.

A)&#($
A)&#($
9 @his =:P descri+es the process of
pannin!, performin!, reportin! and foow)
up of different audits for your systems i'e
(nterna 4uaity audit, Fendor audit,
Environmenta Eeath and =afety BEE=C
audit, EE= wor'pace inspection,
Eouse'eepin! audit.
9 @his =:P aso descri+es the process to +e
foowed +y manufacturin! personne
durin! an audit from a ?e!uatory
authority.

E3am'*%Ch%02*#$( .!r Ba(0h D!0)m%"(a(#!"
E3am'*%Ch%02*#$( .!r Ba(0h D!0)m%"(a(#!"
9 @his =:P descri+es the identification of a
documentation reevant to a production
process in the form of GBatch
Documentation -hec'istsH and to ensure
their coection +y competion of the
chec'ists +y Authori2ed Persons.
9 @his procedure is +ased on an e<ampe of
ta+et pac'a!in! process descri+ed in the
I6anufacturin!8 cate!ory.

E4a*)a(#!" !. Ba(0h D!0)m%"(a(#!"
E4a*)a(#!" !. Ba(0h D!0)m%"(a(#!"
a"& R%*%a$% .!r Sa*%
a"& R%*%a$% .!r Sa*%
9 @his procedure descri+es the process of
coection, evauation and record of +atch
reated document !enerated durin! the
production of a +atch +efore an authori2ed
person can reease the +atch for sae.
9 @his procedure is +ased on an e<ampe of
ta+et pac'a!in! process descri+ed in the
I6anufacturin!8 cate!ory.

GMP Tra#"#"-
GMP Tra#"#"-
9 @his =:P descri+es how to desi!n
and deiver 56P reated trainin! for
your manufacturin! staffs, trainin!
assessment desi!n, recordin! of
assessment and preparation of
trainin! reports.

H!/ (! Wr#(% Tra#"#"- Ma(%r#a*$
H!/ (! Wr#(% Tra#"#"- Ma(%r#a*$
9 @his simpe =:P contains instructions
on how to write trainin! materias,
identification of trainin!
re3uirements, avaia+e resources,
preparation of trainin! aid chec'ists
for your manufacturin! staffs.

H!)$% 8%%'#"- A)&#( Pr!0%&)r%
H!)$% 8%%'#"- A)&#( Pr!0%&)r%
9 @his =:P descri+es the re3uirements, chec'ists
and reportin! procedure on house'eepin! audits.
9 (ndividua chec'ist forms are attached at end of
the procedure for different areas i'e process,
a+oratory, en!ineerin! stores, warehouses.
9 @his procedure aso descri+es the handin! of
non)compiance found durin! the house'eepin!
audits.

Ma"a-%m%"( a"& C!"(r!* !. C!"(ra0( W!r2
Ma"a-%m%"( a"& C!"(r!* !. C!"(ra0( W!r2
9 @he procedure descri+es the
mana!ement and contro of contract
wor' provided +y the contractors for
pac'a!in! and finished products for
your company as we as contro of
contract wor's done +y your
company on +ehaf of others.

Cr#(%r#a .!r S!)r0#"- !. RM, Cr#(#0a*
Cr#(%r#a .!r S!)r0#"- !. RM, Cr#(#0a*
Pa02a-#"- C!m'!"%"($ a"& Im'!r(%&
Pa02a-#"- C!m'!"%"($ a"& Im'!r(%&
F#"#$h#"- G!!&$
F#"#$h#"- G!!&$
9 @he purpose of this =:P is to descri+e the process
for approva of an e<terna vendor;manufacturer
suppyin! products to your company.
9 (t covers raw materias Bincudin! +u' products
for su+sidiaries and contract manufacturersC,
critica pac'a!in! components in contact with
product and imported finished !oods.
9 @he =:P aso references affiiated documentation
detaiin! the scope of active materias used and
the approved manufacturers of these materias.

Q)a*#(, C!"0%r" I"4%$(#-a(#!"
Q)a*#(, C!"0%r" I"4%$(#-a(#!"
Pr!0%$$
Pr!0%$$
9 @his procedure contains instruction to +e foowed
when conductin! (nvesti!ations and to raise and
assess Deviation ?eport when an investi!ation or
incident (nvesti!ation occurs.
9 @his procedure is to +e used in conjunction with
=:P, which covers the approva and foow)up
activities associated with a Deviation ?eport.
9 Eere you wi find coection of information for an
incident or a deviation, steps to +e foowed for a
cross functiona investi!ation, reportin! and
impementin! of the outcomes of investi!ation.

Quality Control Laboratory
Procedures

R%(%$( Da(#"- !. Ra/ Ma(%r#a*$
R%(%$( Da(#"- !. Ra/ Ma(%r#a*$
9 @he purpose of this procedure is to
descri+e how to run the e<pired stoc'
reportJ to descri+e how to define the
re3uirements for the retestin! and
assi!nment of stora!e period for active
in!redients, e<cipients and raw materiasJ
to instruct retestin! procedure and to
determine the status of a finished !oods
+atch with a shorter shef ife.

Ca*#+ra(#!" P!*#0#%$ .!r La+!ra(!r,
Ca*#+ra(#!" P!*#0#%$ .!r La+!ra(!r,
I"$(r)m%"($
I"$(r)m%"($
9 @his =:P descri+es the cai+ration poices
of a+oratory instruments;e3uipments.
9 (t descri+es a+ein! and security
re3uirements of a+oratory
instruments;e3uipments.
9 @his =:P aso descri+es the investi!ationa
steps to +e re3uired in the case of faied
cai+ration

Ar0h#4#"- La+!ra(!r, D!0)m%"(a(#!"
Ar0h#4#"- La+!ra(!r, D!0)m%"(a(#!"
9 @his procedure descri+es retention and
disposa procedures of a+oratory
documentation, !enera a+oratory
documentation system that incudes
handin! of rejected raw materia and
finished product reports, finished !oods
certificate of anaysis, finished !oods
re!ister, raw materia certificate of
anaysis, re!ister, trend cards, procedure
for on! term document retention.

Ma"a-%m%"( !. R%.%r%"0%
Ma"a-%m%"( !. R%.%r%"0%
S)+$(a"0%$
S)+$(a"0%$
9 @his =:P descri+es the orderin!
referencin!, storin!, codin!, use and
!enera re!ister maintenance of primary
and impurity reference su+stances,
primary rea!ent reference soutions,
secondary raw materia reference
su+stance, assay testin! procedure of
secondary raw materia reference
su+stance, use of secondary raw materia
reference su+stance in the a+oratory
routine anaysis, determination of e<piry
date and re)test date of reference
su+stances.

La+!ra(!r, W!r2+!!2
La+!ra(!r, W!r2+!!2
9 @his =:P descri+es types of a+oratory
wor'+oo's, !enera and 56P re3uirements
of usin! wor'+oo's, anaytica data entry
in the wor'+oo', formattin! of a+oratory
wor'+oo's for routine testin!,
e<periments and trias, wor'+oo'
retention poicy, instruction on data entry
for incompete e<periments and additiona
data.

Cr%a(#!" !. C%r(#.#0a(% !. A"a*,$#$
Cr%a(#!" !. C%r(#.#0a(% !. A"a*,$#$
9 @he purpose of this procedure is to
define the content and format of a
-ertificate of Anaysis B-;AC and
-ertificate of 6anufacture B-;6C and
to provide !uidance for issuin! a
-ertificate of Anaysis or -ertificate
of 6anufacture and to ocate the
appropriate data re3uired for this
tas'.

Ma"a-#"- A"a*,(#0a* R%a-%"($
Ma"a-#"- A"a*,(#0a* R%a-%"($
9 @his procedure identifies the need for a
anaytica rea!ents and soutions prepared
from the rea!ents, to have an assi!ned
e<piry date and stora!e conditions
recorded on the a+e.
9 Eere you wi find the procedure for
purchase and mana!ement of anaytica
rea!ents and a+oratory prepared
rea!ents.

La+!ra(!r, Wa$(% Ma"a-%m%"(
La+!ra(!r, Wa$(% Ma"a-%m%"(
9 @his simpe procedure descri+es how
to dispose off a+oratory !enerated
wastes of to<ic, e<posive, famma+e,
corrosive, o<idi2in! and +ioo!icay
dama!in! natures.

R%(%"(#!" Sam'*%$La+!ra(!r,
R%(%"(#!" Sam'*%$La+!ra(!r,
9 @he purpose of this =:P is to
descri+e the finished !ood and raw
materia sampe retention
procedures, products manufacture
and;or received onsite and;or
chemicay tested +y the a+oratory.

La+!ra(!r, S)''*#%r A''r!4a*
La+!ra(!r, S)''*#%r A''r!4a*
9 (n this simpe =:P you wi find the
procedure for approvin! a+oratory
suppiers and criteria for the
purchase of e3uipment,
instrumentation, consuma+es,
dura+es and !assware for the
a+oratory.

La+!ra(!r, R%$)*($O)( !. S'%0#.#0a(#!"
La+!ra(!r, R%$)*($O)( !. S'%0#.#0a(#!"
I"4%$(#-a(#!"
I"4%$(#-a(#!"
9 @his procedure descri+es the actions to +e ta'en +y
an anayst in the event the resut of a test does not
conform to raw materia;components or finished
products specifications for physica and chemica
tests.
9 An out of specification B::=C resut does not
necessariy mean the +atch under investi!ation fais
and sha +e rejected.
9 @he ::= resut sha +e investi!ated and the
findin!s of the investi!ation, incudin! re)test
resuts sha +e interpreted to evauate the +atch
and reach a decision re!ardin! reease or rejection.

Ra/ Ma(%r#a*$La+!ra(!r, T%$(#"-
Ra/ Ma(%r#a*$La+!ra(!r, T%$(#"-
a"& D!0)m%"(a(#!"
a"& D!0)m%"(a(#!"
9 @his =:P descri+es the procedure for
sampin!, ocation, pre)testin!,
testin! and documentation of a raw
materias and components su+ject to
test, out of specification resuts,
micro+ioo!ica tests and reease
procedure for passed raw materias
and components.

F#"#$h%& G!!&$La+!ra(!r, T%$(#"- a"&
F#"#$h%& G!!&$La+!ra(!r, T%$(#"- a"&
D!0)m%"(a(#!"
D!0)m%"(a(#!"
9 @his =:P descri+es the procedure for
sampin!, ocation, pre)testin!,
testin! and documentation of a
finished products su+ject to test,
rea!ents and standards to +e used
for anaysis, mana!ement of out of
specification resuts, micro+ioo!ica
tests and reease procedure for
passed finished !oods.

Pr%'ara(#!" a"& Ma#"(%"a"0% !.
Pr%'ara(#!" a"& Ma#"(%"a"0% !.
S(a+#*#(, Pr!(!0!*$ 9Pharma0%)(#0a*$:
S(a+#*#(, Pr!(!0!*$ 9Pharma0%)(#0a*$:
9 @his procedure descri+es the preparation and
mana!ement of sta+iity protocos for mar'eted
products.
9 @his procedure is appica+e to a protocos for
sta+iity studies on commercia products.
9 @he responsi+iity of the commercia =ite sta+iity
mana!er for creatin! and maintainin! protocos
that are re3uired for studies that came as a resut
of vaidation or process deviation.

S(a+#*#(, a"& Tr#a* T%$(#"- Pr!0%&)r%
S(a+#*#(, a"& Tr#a* T%$(#"- Pr!0%&)r%
9Pharma0%)(#0a*$:
9Pharma0%)(#0a*$:
9 @o descri+es the steps necessary to ensure the
effective contro of sta+iity and tria testin!
pro!rams of new and e<istin! products.
9 @his procedure is focused on settin! up of
sta+iity pro!rams, testin!, reportin!, !enera
sampin! procedure for sta+iity pro!rams, data
!eneration and anaysis, annua maintenance of
sta+iity, new product sta+iity procedure,
procedure for in)house trias, reportin! and
interpretation of trias and concusion of the trai
pro!ram.

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?EKE?EN-E=
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