GOOD DOCUMENTATION PRACTICES
Pharmaceutical Documentation Presented By Dr.Safder Ali Bhatti
Assistant Manager Production
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Content of PresentationIntroductionGood Documentation needsWhy
essential?Types of documentation Constitutes of Good
documentationChanges or Amendments in DocumentationCommon
Documentation ErrorsPrinciples of Good Documentation
PracticeBenefits of Good Documentation Practice
IntroductionWhat is Documentation? Documentationis any
communicable material that is used to describe, explain or instruct
regarding some attributes of an object, system or procedure, such
as its parts, assembly, installation, maintenance and use.
Documentation provides Both;Information on when, where, who, why
& How to Complete tasksEvidence providing that the tasks have
been completed as they should be.
IntroductionGood Documentation Practice(GDP) ?GDP describes the
standards by which documentationis Created and Maintained in the
pharmaceutical industryThe basics of GDPTo meet industry Standards,
it is critical that all documentation follow GDP when it
effects:GMP processesMaterials or product identity, quality,
strength & safetyThe validated state of GMP product
manufacture, facilities, equipment, computer systems and testing
methods.
Document is information (meaningful data) and its supporting
medium, in form of paper, CD, Computer file, microfilm, x-Ray film
etcDocuments provides information or evidence or may serve as an
official record.Recordis a document stating results achieved or
provide evidence of activities performedIntroduction
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IntroductionGuidelines is a document that provides recommended
practices and instructionsPolicy is a plan or adopted course or
principle of action intended to influence and determine the
decisions or actions of an organization
Good documentation needs?Approve, review & update
documentsChange & current revision status of document
identifiedRelevant versions of applicable documents available at
point of useDocument remain legible and readily
identifiableDocuments of external origin identified and their
distribution controlledPrevent unintended use of obsolete
documents, and archiving.
Why Good Documentation is essential?In a GMP Environment,
Documentation needs to meet certain requirements to ensure Product
Quality & Product Safety.If an instruction or record is poorly
documented, then the manufacturer or Quality assurance/control of a
product can be negatively impacted, potentially reducing patient
safety.Consequently, the standards of documentation within a
company can directly impact the level of success in manufacturing
quality products that are safe as well as success during audit
situations.
Ensures documented evidence, traceability, provide records and
audit trails for investigationEnsures availability of data for
validation, review and statistical analysis.Control of Process -
Ensures all staff knows what to do and when to do it.To improve
performanceRegulatory requirements.
Why Good Documentation is essential?
Purpose of Laboratory DocumentationTo provide the basic guide
for good document practices with regard to creation, approval,
review, maintenance, correction or errors, verification and
archiving etcEnsures documented evidence, traceability, provide
records and audit trails for investigationEnsures availability of
data for validation, review and statistical analysis.Control of
Process - Ensures all staff knows what to do and when to do it.To
improve performanceRegulatory requirements.9
Types of DocumentationDocumentation may be divided
into;Documents-procedural or instructional
documentationBenefits:Reference for future use or a means to
communicate information to others.Particularly important to ensure
that knowledge is not lost when employee leaves.Ensure the Quality
& Consistency of processed/activities/manufacturing
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Types of Document Used
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Types of DocumentationRecords-evidence of
ComplianceBenefits:Provide background historyProtects intellectual
property(Evidence of an idea or a finding including the date and
the responsible person)Provide legally valid evidence
Types of Records used
What constitutes Good DocumentationClearly Written
documentation:All documents must be accurate & written in a
manner that prevents errors and ensure consistency.Using indelible
ink:All records must be filled out in indelible ink for long term
legibility. Dont use pencil or ink that can be erasedLegible hand
written entriesReviewing & approvingStaff Signatures:Hand
written Signature must be unique to the individual and listed
within the site signature register to ensure that signature is
traceable to a member of staff. Staff are not permitted to sign for
another member of staff unless delegated.Page Numbering
What constitutes Good DocumentationConcise: The document must
provide clear information that is understood by all
customersTraceable: Who recorded it, where and whyContemporaneous:
The information should be documented at the correct time frame
along with flow of eventsEnduring: Long lasting and
durableAccessible: Easily available for review.
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Changes or Amendments are made in a Compliant mannerMaking a
Legible Correction:If correction needs to be made, the original
record must still be legible:Make a single line through the
error-never use correction fluid, multiple cross- marker pen to
obscure the original record.Provide a brief comment why the change
is required(as appropriate)Initial the change so that it is clear
that the correction is deliberate.Record the date of the correction
next to the initials so that there is a record of when the change
was made.
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Making a Legible Correction:
Changes or Amendments are made in a Compliant mannerHandling
Omitted data:If an entry was omitted and must be made at a time
later than the activity was performed then:Clearly indicate the
date the activity was performed and the date the activity is
recorded on the documentation.Document an explanation to
substantiate the entry & reason for the delay in recording.Sign
& date the change.Important: Back dating of entries is not
permitted
Handling Omitted data:
Common Documentation ErrorsMissing signature and dates at the
time of activity performed.The write-overNon-uniform date and
signature entryWriting a note that activity was performed on one
day and signed for on other day.Blank spacesIllegible writingToo
many corrections
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Principles of Good Documentation PracticeA document bearing
original signatures should never be destroyed.Never falsify
informationNever you a White-out and cover-over-tapesNever
obliterate information or recordNever over-write a record.Never use
pencil all information should be completed in permanent Black or
Blue inkNo spaces, lines or fields are to be left blankNever use
symbols e.g ditto marks or arrows to indicate repetitive and
consecutive
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Benefits of Good Documentation PracticeBuild confidence in the
Quality of productReduce efforts to compliance with regulatory
bodiesAllows for achievements of required results.Correct,
complete, current and consistent information effectively meets
customers and stakeholders requirements.Enables the Production
activities to be arranged into functional patterns for specific
action.Create structures so that staff can systematically
coordinate to conduct business.
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Benefits of Good Documentation PracticeTraining of production
staff.Solve complicated problemsReduce or eliminate assumptions and
second-guessingEliminate the need to re-ask the same
questionsSpecify clear instructions for staff
