DOCUMENTATION
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Novo Nordisk ROFE BA
Slide No. 1 • • 25.Mar.2008
GOOD DOCUMENTATION PRACTICE
(GDP)
Document No 054929
Edition 4.0
Effective Date: 01 Nov 2006
Novo Nordisk ROFE BA
Responsibilities
All employees who generate and /or review records are
responsible for complying with this instruction.
Good documentation practice is necessary when
documenting:
– The properties contracts and quality of products
– The quality of development processes
– Non-clinical studies
– Clinical studies
– Device manufacturing processes and studies
– Manufacturing and distribution processes.
Novo Nordisk ROFE BA
Slide No. 3 • • 25.Mar.2008
Good Documentation Practice
PURPOSE
The purpose of this instruction is to describe:
• General common guidelines for good documentation
practice for GxP (GMP, GCP,GLP) and ISO areas.
• Specific requirements that apply to entry of data into
GxP (GMP, GCP,GLP) and ISO records in order to
ensure compliance with the expectations of the health
authorities and the certifying bodies.
Novo Nordisk ROFE BA
Slide No. 4 • • 25.Mar.2008
Good Documentation Practice
SCOPE
This instruction applies to:
• All departments at NN performing GxP (GMP, GCP, GLP,
GDP) regulated activities.
• All information from clinical studies and device studies.
• All departments at Novo Nordisk that are ISO 9001-
certified.
Novo Nordisk ROFE BA
Slide No. 5 • • 25.Mar.2008
Records – general requirements
The requirements for good documentation practice apply
for all records.
Data should be recorded immediately after an
action has been performed.
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Novo Nordisk ROFE BA
Slide No. 6 • • 25.Mar.2008
Novo Nordisk ROFE BA
Slide No. 7 • • 25.Mar.2008
Good Documentation Practice
Signing
• All data records must be signed and dated by
the person responsible for the records.
• Only the first page can be signed and dated if it is
explained that the signature covers all pages.
Eg:
• Approval of promotional material
• Product Labeling proofs
• Agreements /Contracts
Novo Nordisk ROFE BA
Slide No. 8 • • 25.Mar.2008
Good Documentation Practice
Date Format
Novo Nordisk ROFE BA
Slide No. 9 • • 25.Mar.2008
Good Documentation Practice
Time format
Statements of time should be unambiguous,
e.g. HH:MM:SS or HH:MM.
Observation and data
Data should be recorded as observed (same format, unit,
digits/decimal places, etc.) unless otherwise specified.
Rounding rules
If the figure that is to be rounded is < 5, this figure is removed
and the preceding figure remains unchanged.
E.g.: 10.3 is rounded down to 10.
If the figure is ≥ 5, this figure is removed and the preceding
figure is increased by one. E.g.: 10.7 is rounded up to 11.
A rounded value must not be rounded again.
Novo Nordisk ROFE BA
Slide No. 10 • • 25.Mar.2008
Good Documentation Practice
Checkmark
The checkmark (√ ) can be used when reviewing drawings and
lists, on condition that the significance and use of the checkmark
are explained in the approved document (e.g. test plan/test
form).
Arrows
Arrows (e.g. ←↑→↓) can be used e.g. when stating directions in a
drawing, on condition that the significance and use of the arrow is
explained in the approved document (e.g. test plan/test form).
Repetitions
Repetition signs and ditto marks (e.g. –” “- ) must not be used.
Novo Nordisk ROFE BA
Slide No. 11 • • 25.Mar.2008
Good Documentation Practice
Unused fields
If fields in pre-printed forms are not used, these fields must be
deleted or marked with ….N/A…. If a record was expected in the
field (e.g. a test result or a process parameter), a dated and signed
reason must be given for why the field has not been used.
Eg: Temperature chart
Abbreviations
Abbreviations, contractions and symbols should be unambiguous
and identifiable. Use the NN abbreviations list on the Intraweb.
Eg: HR, PR, KOL
International System of Units (SI) system
SI units or units derived from these should be used wherever
possible:
– SI units: http://www.bipm.fr/en/si/
– Derived units: http://www.ex.ac.uk./cimt/dicunit.htm
Novo Nordisk ROFE BA
Slide No. 12 • • 25.Mar.2008
Good Documentation Practice
Page numbering
All pages of printouts/paper/enclosures should state the page
number and the total number of pages.
E.g. page x of y pages.
Enclosures
All enclosures and associated documents should be traceable to the
records to which they belong.
Eg: Enclosure I, to Change Request 2007-01, Date 25 Oct 2007,
Version 1.
Damaged records
If a record becomes damaged or dirty and a replacement is needed,
the original record must always be attached to the replacement.
– Both old and new doc should be archived together
Novo Nordisk ROFE BA
Slide No. 13 • • 25.Mar.2008
Good Documentation Practice
Manual records
Paper Records
Manual data records should be made in clear, legible handwriting.
Sufficient space should be provided for such entries.
Data records can be made in worksheets, experiment workbooks,
batch documentation, logbooks, study plans, etc.
Eg: Finance reports, Temperature logs, Contract lists, Signature
logs
Corrections
Corrections to printed or handwritten data must be made so that
the original text is legible. So Strikeout the mistake, write the
correction, signature/initials and date.
Novo Nordisk ROFE BA
Slide No. 14 • • 25.Mar.2008
Good Documentation Practice
Correcting Data
• Must not obscure original values
• Never use “White outs”
• 3 Items must be visible each time a value is changed
• The old value
• The new value
• By whom was the change made
– This applies to both written and electronic
changes or corrections.
• Insertion of data :- never squeeze in , add after last
entry
Novo Nordisk ROFE BA
Slide No. 15 • • 25.Mar.2008
Good Documentation Practice
GxP pens
Data records should be made with water-proof, permanent ink.
It is recommended to use BLUE ball pen.
– Pencil / non indelible ink is not ok
Data records must not be made using highlighter pens.
Date stamps
A stamped date can be used instead of a handwritten date if
the date format observes this instruction and the stamped date
are signed.
Transcription of data
If data is transcribed, it must be traceable to the original
record.
– Eg: Abstracts taken from published papers – accurate reference must be
made
Novo Nordisk ROFE BA
Slide No. 16 • • 25.Mar.2008
Good Documentation Practice
Manually entered electronic records
The correctness of the entries must be ensured for data that is
manually entered in to PC.
This can be done by another person checking the entries, or by the
computer system automatically ensuring this (e.g. through control
entry/double entry of data).
An Electronic Record is created when data is saved on a durable
recording medium (e.g. diskette or tape).
Refer: QBIQ no. 042362 & 026652.
Review and Approval of Records
There should be a system or an operational document to describe the
review and approval of records and how this is documented.
Ref: ROFE Doc. 040300
Novo Nordisk ROFE BA
Slide No. 17 • • 25.Mar.2008
Good Documentation Practice
Special rules for GCP
General
• Records should be approved prior to issue.
• Records should be reviewed, updated and re-approved as necessary.
• Changes and the current version status of records should be
identifiable.
• Records should be readily accessible and should always ensure
accurate reporting, interpretation and verification.
• Obsolete records should be clearly marked to prevent unintended use.
Novo Nordisk ROFE BA
Slide No. 18 • • 25.Mar.2008
Good Documentation Practice
Lost records
If a record is lost and a copy exists, the copy can be used in lieu
of the original. The following should be added to the record:
“Copy used in lieu of original as original was lost”.
Review and approval of records
If an error is discovered during the review, the necessary
actions should be taken.
Review and approval of records should be carried out in
accordance with applicable operational documents.
Novo Nordisk ROFE BA
Slide No. 19 • • 25.Mar.2008
Special rules for Good Distribution Practice
• It is the Responsibilities of the department and the
associated quality unit should review and approve all
necessary quality-related records.
• Document related to quality of product to be reviewed
and signed by LQRP
– Eg: Non conformity report, Product Recall report,
Release of products, Customer complaints
Novo Nordisk ROFE BA
Slide No. 20 • • 25.Mar.2008
Novo Nordisk ROFE BA
Slide No. 21 • • 25.Mar.2008
