gdp module
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8/19/2019 GDP Module
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8/19/2019 GDP Module
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ObjectivesAcquire basic knowledge of Good Documentation Practices
Unlock the potential of individual using the document
Amplify the value of your product Build condence in your quality
Good Documentation helps to save the papers
educe the e!orts to compliance with regulatory bodies Good documentation enables to achieve the results that
you are seeking for"
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#hat is Documentation $
%o Document each Activity you perform having
one &o' Documentation is a Process' #hich
comprises of (ollowing ) * ecording of Data *
Approval of Documents * +ssuance and Disposal
of Documents * etrievability of Documents *
Presentation of Documents * eview of
Documents
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Good DocumentationPracticesGood Documentation practice GDP ,ight*rst*
time- approach for the document is GDP .to
ensure identity' authenticity and accuracy of
records"/+f your Document says -#hat actions
took place in the development or manufacturing
of product so that anyone' including auditor or
inspector has documented evidence that you
did e0actly what you said 1 that is GDP"
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%he purpose ofdocumentationProof of fact
ecord
egulatory requirement"
2uality maintenance and improvement .Better
risk management and robust quality systems/"3ontrol the processes .esource optimi4ation /
-5our documentation is an advertisement foryour work1"
6nd User requirements"
%o improve performance"
6nables important messages to be
communicated clearly and accurately"
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(DA statement should drilled into you from day one
-+f you didnt document it' then it didnt happen1"7n one hand do the work' 7n other make the
document"
Use indelible .water*resistant/ blue or black ink"
&ever use #hite ink to remove errorDo not use pencil or felt*tipped marker"
&ever overwrite or 8cribbled the entry" 9ust singlecut the error with sign and date"
&ever leave space or blank in the document andDraw a diagonal line through any blank elds orempty spaces at the bottom of a page and include&:A along with your initials and date"
;ow to acquire GDP $
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What are the Common Document Error
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8/19/2019 GDP Module
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#hy Documentation $
3ost for Good Documentation"
3ost for Poor:&o Documentation"
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Incompleteness of documentDocument which doesn=t has sign and date of the
approval consider as the incomplete document"
All documents shall be signed by the originator"
&o signature pads' scanned signatures' orduplicated original signatures shall be used toreplace a handwritten signature by the personsigning"
Documents shall be signed in permanent ink"
8pecimen 8ignatures shall be kept throughout thelife of the document"
%he local date shall be used to date documents"
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Documentation life cycleDocument creation > Approval) * %he process
owner or the authori4ed person should write as perthe specic format and template and circulate thedocument after getting approval of 2A"
Document use > Data collection) * esponsibility of
all technicians' engineers' scientists' operatingpersons who are trained and authori4ed to collectand record data"
Data ?erication) * esponsibility of supervisors'
managers and all individuals trained > authori4edto review data" ecord eview > Productdisposition : Approval) * esponsibility of 2A orthose trained > authori4ed to review records
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ecord Archiving)*ecords are Accessible' etrievable' 8ecure is the
responsibility of 2A > relevant departments"
ecord Destruction) * As per 87Ps that directs the
destruction of documents
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3reating the Documents$
During implementation' all &ew Processor documentation is created andProcedure tested by all impacteddepartments"
All 3hange to an e0isting documentationis reviewed' Process or Procedureupdated' and tested by all impacteddepartments"
Annually' review all documentation to
ensure it is accurate" Use as Periodiceview part of continuous processimprovement cycle to evaluate need forchange"
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#here documentation $
Documentation during Pro@ect Design' Documentation during 3onstruction Phase'
Documentation during 3ommissioning and start*up'
Documentation during 2ualication and?alidations'
Documentation during 3ommercial Production'
Documentation during %esting and elease'
Documentation for egulatory submissions" Documentation beyond
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8/19/2019 GDP Module
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GDP standards Document creation3ontemporaneous with the event they describe"
#hen electronically produced' the documentation
must be checked for accuracy"
(ree from errors"
(or some types of data' the documentation must be
in a format that permits trend evaluation Document
approval"
Approved' signed' and dated by appropriate
authori4ed personnel"
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GDP guidelines
(or ;andwritten entries adequate space is to be providedfor e0pected handwritten entries"
;andwritten entries are in indelible ink"
3ritical entries must be independently checked .second
person veried/"
&o spaces for handwritten entries are left blank * if unused'
they are crossed out or ,&:A, .or similar te0t/ entered"
Ditto marks or continuation lines are not acceptable"
A stamp in lieu of a handwritten signature is not
acceptable "
+f electronic signatures are used on documents' they should be
authenticated and secure"
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3orrections:Additions +n ecord
8ingle line through the information that needs to be
corrected" All corrections or additions shall be signed and dated" 8hould not to scribble out the original data' use
white out or write over data " +n Document 7nly personnel who have already been
approved to write or make changes to document cancorrect or add to documents"&on*typographical error corrections or additions
indicating a change in data or acceptance status
require a comment" %ypographical error is routed through full document
3hange control" Document 3reation and 3hangeequest form"
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Attributes of a good document
C attributes of a good document
o Accurate
o 3lear
o 3omplete
o 3onsistent
o +ndelibleo egible
o %imely
o Direct
o Authentic
o Authori4ed
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