gdp module

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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#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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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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