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7/29/2019 Qualification vs Validation and Good Cold Chain Management Practices
$ RafikH. Bidwa is a TecfnicalAdvisoro Sensileclfnc.H€ s [rc Chair f ü|e Phannffi*icd ColdChainDiscussion lotp.Parent€ralttw Associatim. rBisharaetired rqr hisposition s Dircclor, Hlity Knowleq€ /hnagflst andTecinicalsuppo( oaEli illy adCqnpanyn tectfiber 2ü)4 afrera 35-year are€r riltr ie corpory. He eceir,€d PfiD rqn Rrü|e UnivelsiE,ndiam,USA.
Historically,he ermsqualification'and validation'have een sedinterchangeablyithinhecold hainndustry,hishas ed o a significantamount f confusionn hepharmaceuticalndustry,hich ould eavoidedbystandardisinghedefinitionsf bothqualification'and validation',
codeofrdb.l R.guldld6 (CrS (1)
Marh 2003 FDA 83 ciritimi \he shipflenrbt nd ol finßned vbls fM ore s& ro anorls is rc! ya Elidaled"ocrober oo4Fo A443 c[.rlon:"5hippir4validariswas eficienf (7)
The ParcnteralDrug Association PDA) 'Cold chainguidance or medicinalproducts naintaining thequality of temperature-sensitive edicinal Foductsthrough the transportationenvironment' 8), allows
ftrms to develop heir ovn processes nd also tomaintainalignmentwith CDER's Generalhinciples
of hocess Validation 9):
a Component ualification CQ) - establishingconfidence hat aücillary componentsare
capableof operatingwithin established imits
and tolerancesI Operationqualification (OQ) - establishing
confidence hat the process s efective and
reproduciblea Performancequalification (PQ)
establishingconfidencethough
apFopriate testing that the product
producedby a specific prccessmeetsall
release equirementsor functionality
The three qualification components are the
foundation ofqualification andvalidation. As these
two terms are frequently misuse4 it is imporiantto first understand how both qualificarion and
validation have been defined by tbe PDA
Pharmaceuticalold ChainDiscussion roup:
Qualification: a documented testing that
demonstrateswith a high degreeof assunnce hata specific process will meet its pre-determined
Table1 comparison f GmdStomgpPracticesGSP)ttersröGood ransporrdion ractices GIP)
that are expected o be typical for the t ?e of packagebasedon
a number of factors, ncluding:
a Temperature onditions at origin and destination
a Seasonalemperature winter verzus summer)
a Load configurationsa Tnnsport routes and modes(ovemight air,
groun4 intemational and so on)a Total duration of transit
O Duration nd ocation fhandling
and stop-overpoints
I Product andling
By studying these va ables in multiple combinations,an
organisations able to gain a level of confidence egarding
how their packaging,processesand actions of their
conhacted service providerswill work togetherwith the
common goal of safeguardinga product during storage
and distdbution.
while quality principles ar e used to reliably qualify
the cold chain distributionprocess,t is to be acknowledged
that even a qualified process s subject to change over
time. Therefore, periodic and appropriatemonitoring is
recommended. The frequency and type of monitoring
will be based on the specific conditions of a given
distributionprocess.
USP <1079> good storage and shipping practices for
qualification of cold equipment or stores states:"Quatification procedures on a regulat basis should be
independently conducted on equipment in cold storesto guarantee suitability and proper functioning. Theprocedure should demonstrate the temperature profile
for for both air and product tempemtures when empty as
well as when loaded," Furthermore, as listed in USP<1079>, "the Presqiption Drug Marketing Act of 1987
and 2l CFR Part 203, Prescription Drug Marketing,
and Part 205, Guidelines fo r State Licensing
of Wholesale PrescriptionDrug Distdbutors, provide the
necessary egulationsand guidance or several egs of the
distribution chain for the prescription drug. The
GIP
Off-site
Handling of pmduct Static
Manufacturerconrols On-site
Environmental mpact Easier o cofnol.{essvarialrle
Documentation compreressranda'd
y?"J;jg ü.:ill';"Regulatoryequnemenrs Have €en tandard Recent xp€ctationsy
for CGMPl::uratory
asenc,esas
While qualification is used to provide a high degree of
assurancehat a processs replicable under anticipatedvariable
ranges,validation is used o describehow a systemwill perfotm
underhighlycontrolled onditions.
Based on the definitions above, it is easy to see how these
definitions are interchanged.However, the key difference is
determinedby whether or not theprocessunder review operates
under'highly controlled' onditions.
The manufacnring environment operates under cGMP-basedprocessesnd- by definition - is 'highly controlled'.Therefore,
manufacturing prccesses can be 'validated'. However, the
distribution environment s widely variable and"dependsupon a
rangeoffactors includingpointsoforigin and destination,article
and container sensitivities o col4 accidental reezing or heat,
transit mode (such as ait truclq sea" or combination), time,