Validation Part5
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Transcript of Validation Part5
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7/21/2019 Validation Part5
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Validation | Slide 1 of 31 August 2006
Validation
Supplementary Training Modules onGood Manufacturing Practice
WHO Technical Report Series,No !"#, $%%& 'nne( )
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Validation | Slide 2 of 31 August 2006
Validation
Part 1. General overview on qualification and validation
Part 2. Qualification of HVAC and water systems
Part 3. Cleaning validation
Part . Analytical met!od validation
Part * +omputeried system -alidation
Part ". Qualification of systems and equi#mentPart $. %on sterile #roduct #rocess validation
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+omputeried systems -alidation
Part *
Supplementary Training Modules on
Good Manufacturing Practice
WHO Technical Report Series,
No !"#, $%%& 'nne( ) 'ppendi( *
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Validation | Slide 4 of 31 August 2006
Validation
O./ecti-es
To discuss -alidation of computeried systems including0
&ystem s#ecifications
'unctional s#ecifications&ecurity
(ac)*u#s
Validation+
, Hardware, Software
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Validation
GeneralValidated * level a##ro#riate
, or their use and application.
Production and quality control.
Com#uter systems used in #lanning- s#ecification-
#rogramming- testing- commissioning- document o#eration-
monitoring and modifying.
Validation+ vidence and confidence, intended use, accuracy, consistency and reliability.
11 2 1"
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Validation
General 3$4
(ot! t!e system s#ecifications and functional
s#ecifications s!ould /e validated.
Periodic 0or continuous evaluation s!ould /e #erformed
after t!e initial validation.
1) 2 1*
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Validation
ritten #rocedures for+, performance monitoring, change control, programme and
data security, calibration and maintenance, personneltraining, emergency recovery and periodic re-evaluation
uring validation- consider+, networks, manual back-ups, input/output checks, process documentation, monitoring
, alarms, and, shutdown recovery
1& 2 1#
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Validation
System specification 3+ontrol document4 4n #lace- stating+
, objectives of a proposed computer system
, the data to be entered and stored
, the flow of data, how it interacts with other systems and procedures
, the information to be produced
, the limits of any variable
, the operating programme and test programme
(Examples of each document produced by the programme
should be included) $1
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Validation
System specification 3+ontrol document4 3$4
&ystem elements t!at need to /e considered in com#uter
validation include+
, hardware (euipment!, software (procedures!
,people (users!
$$
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Validation
5unctional specification 3Performance specification4
Provide instructions for+
, testing, operating, and maintaining the system
, names of the person(s! (development and operation!
!en using com#uter systems- consideration+, location
, power supply
("luctuations in the electrical supply can influence computersystems and power supply failure can result in loss of
memory!., temperature
, magnetic disturbances "1 2 "$
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Validation
5unctional specification 3Performance specification43$4
G5P requirements for com#uter systems+
Verification and re-alidation, #fter a suitable period of running a new system
, $ndependently reviewed and compared with the systemspecification and functional specification +hange control
, #lterations made in accordance with a defined procedure, %rovision for checking, approving and implementing the
change
+hec6s, &ata checked periodically, 'onfirm accurate and reliable transfer "$ 2 ""
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Validation
Security
Production as well as in quality control
ata entered or amended * aut!ori6ed #ersons
&ecurity systems to #revent unaut!ori6ed entry or mani#ulation
of data
&7Ps for entering data- c!anging or amending incorrect entries
and creating /ac)*u#s
&ecurity #rocedures in writing)1 2 )"
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Validation
(continued)
8racea/ility is of #articular im#ortance
Audit trail+
, identify the persons who made entries
, identify the persons who made changes
, identify the persons who released material
, identify the persons who performed other critical steps in
production or control
))
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Validation
7ac68ups9egular /ac)*u#s of all files and data
, Secure storage (prevent intentional or accidental damage!
ValidationValidation #rocess s!ould include+
, %lanning
, alidation policy
, %roject plan and S)%s
*1 2 &1
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Validation
Validation 3$4
efine com#uter*related systems and vendors
Vendor and #roduct evaluated
&ystem designed and constructed
, 'onsider types, testing and uality assurance of the
software
:tent of qualification de#ends on com#le:ity of t!e system
&$
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Validation
Validation 3"4
Qualification includes+
4nstallation
valuation of t!e system
Performance
C!ange control- maintenance and cali/ration- security-
contingency #lanning- &7Ps- training- #erformance monitoring
and #eriodic re*evaluation
&"
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Validation
Validation of hard9are
A##ro#riate tests and c!allenges to t!e !ardware
%o influence of static- dust- #ower*feed voltage fluctuations and
electromagnetic interference
Hardware is considered to /e equi#ment
, focus on location, maintenance and calibration as part of
the ualification
#11 2 #1$
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Validation
Validation of hard9are 3$4
4t s!ould #rove+
A##ro#riate ca#acity
7#erational limits
, e.g. memory, connector ports, input ports
Performance under worst*case conditions
, e.g. long hours, temperature e*tremes
9e#roduci/ility;consistency
, e.g. by performing at least three runs under differentconditions
#1"
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Validation
Hard9are types
:istri.ution
system
Peripheralde-ices
Signal con-erter
+entral
Processing
;nit
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Validation
>ey aspectsTo consider
+ommand
o-errides
Maintenance Signalcon-ersion
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Validation
Validation
Reproduci.ility
+onsistencyand
documentation
@imits
Worst case
Re-alidation 5unction
Summary0 Validation re=uirements for Hard9are 3See Ta.le 1 in notes4
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Validation
Validation of Soft9are&oftware+
is t!e term used to descri/e t!e com#lete set of #rogrammes
used /y a com#uter- and w!ic! s!ould /e listed in a menu
9ecords are considered as software
'ocus s!ould /e #laced on+
, accuracy, security, access, retention of records, review,
double checks, documentation and accuracy ofreproduction
#$1 2 #$$
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Validation
=ey com#uter #rogrammes to /e identified+
, language, name, function (purpose of the programme!
, input (determine inputs!, output (determine outputs!
, fi*ed set point (process variable that cannot be changed by the
operator!, variable set point (entered by the operator!
, edits (reject input/output that does not conform to limits and
minimi+e errors, e.g. four- or five-character number entry!, input
manipulation (and euations! and programme overrides (e.g. to
stop a mi*er before time!
4dentification of aut!ori6ed #ersonnel
, to write, alter or have access to programmes #$" 2 #$)
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Validation
Validation of Soft9are 3$4 Points to .e considered may include0
, 'onsistency in performance ithin pre-established limits!
, "unction atching the assigned operational function (e.g.generate batch documentation, different batches of materialused in a batch listed!
, orst case alidation under different conditions (e.g.speed, data volume, freuency!
, epeats Sufficient number of times (e.g. replicate dataentries!
, &ocumentation %rotocols and reports
, evalidation $n case of significant changes made#$*
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Validation
@e-el
High le-el
language
'ssem.ly
language
'pplication
language
Machine
language
Summary0 Validation re=uirements for Soft9are 3See Ta.le 1 in notes4
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Validation
>ey aspects
Soft9are
de-elopment
Soft9are
security
Summary0 Validation re=uirements for Soft9are 3See Ta.le 1 in notes4
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Validation
Validation
Repeats
Worst case
:ocumentation
Re-alidation
5unction
Summary0 Validation re=uirements for Soft9are 3See Ta.le 1 in notes4
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Validation
Grou# session