Good Documentation Practice (GDocP).pdf

TRAINING ON
GOOD DOCUMENTATION
PRACTICE (GDocP)
SOP/QA/039/01
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Trainer: Md. Zakaria Faruki
Manager, Quality Assurance
Silva Pharmaceuticals Limited
GDocP

GOOD DOCUMENTATION PRACTICE
(GDocP)
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GDocP
Trainer: Md. Zakaria Faruki, Manager, QA

 Good documentation practice (commonly abbreviated
GDP, recommended to abbreviate as GDocP to
distinguish from "good distribution practice") is a term
in the pharmaceutical industry to describe standards by
which documents are created and maintained.
 The GDP can be defined as “Good documentation
practice is an essential part of the quality assurance and
such, related to all aspects of GMP” this definition is
based on WHO.
 Good Documentation Practice is a systematic
procedure of preparation, reviewing, approving, issuing,
recording, storing and archival of document.
GOOD DOCUMENTATION PRACTICE
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GDocP

DOCUMENT
Document: Document is guideline for activities. A
document is written, drawn, presented approved instruction
either in paper or electronic form which guides about how
an activity shall be executed.
Documents can be stored as paper or digitally. It can be
changed and revised as needed.
Documents are required for one or more of the following
reasons:
Keep track of activities
Create legal documents
Provide a historical record
Provide information
Comply with regulations
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General Principle of Documentations
 Design (correct, complete, current & traceable)
 Prepared
 Checked
 Reviewed
 Approved
 Authorized
 Proper Distribution
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GDocP

Why GDocP ?
Good documentation practices
(GDP) is required in order to
ensure an auditable account of
work performed.
GDP is required for all
documentations included in a
fully developed quality system.
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According to the World Health Organization (WHO), the
purposes of GDP are:
 To define the specifications and procedures for all materials and
methods of manufacture and control.
 To ensure that all personnel concerned with manufacturing know what
to do and when to do it.
 To ensure that authorized persons have all the information necessary
to decide whether or not to release a batch of a drug /Product for
sale.
 To ensure the existence of documented evidence, traceability and to
provide records and an audit trail that will permit investigation.
 To ensure the availability of the data needed for validation, review and
statistical analysis.
Why GDocP ?
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GDocP

Different types of Documents &
Records
• Batch records
• Specifications
• Validation & Qualification
Records
• Validation Master Plan
• Site Master File
• Training Manual
• Quality Manual
• Laboratory Safety Manual
• Calibration Records
• Standard procedure
• Room Temperature/ %RH
Records
• Stability Study Summary
Report
• Machine Logs
• Product and sample labels
• Analytical Methods
• Manufacturing Procedures
• Standard Testing Procedure
• etc
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Characteristics of Good Documents
– ACCURATE
– AUTHENTIC
– CLEAR
– COMPLETE
– CURRENTVERSION
– LEGIBLE
– PERMANENT
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record
Record: Record is results of activities. are historical
files that provide proof of existence. They are used to prove
a state of existence of the business. Records are not editable
and cannot be recreated. In short it is a historical document.
GMP record should have following characteristics –
Permanent
Legible
Accurate
Prompt (Write at the time activity was done)
Clear (So any one can read and understand what it meant)
Consistent
Complete
Direct
Truthful
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Documentation
Documentation: Documentation is a set of documents that provides
official information or evidence or that serves as a record.
Controlled documents: The document that have limited and specific
distributions and are marked with blue stamped phrase
“Controlled” are termed as controlled documents. It is the distribution
that is being controlled. Examples of controlled documents are Standard
Operating Procedures, Master Formulations, and RM/PM Specifications etc.
Data: Data is a set of values of qualitative or quantitative variables. Facts and
statistics collected together for reference or analysis.
Data should be:
 A – Attributable to the person generating the data
 L – Legible and permanent
 C – Contemporaneous
 O – Original record (or true copy)
 A – Accurate
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DocumentVs Record
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Document Record
Document is guideline for
activities.
Record is results of
activities.
A document is a written, drawn,
presented or recorded
representation of thoughts
Records are historical files
that provide proof of
existence.
It is an editable file. Records are not editable
and cannot be recreated.
Communicate information via
policies, processes, and
procedures
Capture information on
worksheets, forms, labels,
and charts
It can be changed and revised
as needed.
It can be never changed
Need updating Permanent, do not change
Example: Safety manual, SOP,
STP, Validation protocol etc.
Example: Filled
Temperature & RH log
sheet, Filled quality
control record.
GDocP

Some Guidance Documents
 Schedule M of Drug And Cosmetics Act 1940
 ISO Clause 7.5 of ISO 9001:2015 Standard
 US FDA CFR sections 21 CFR 11, 210 & 211
 Guidelines of European Commission, Volume 4, Good
Manufacturing Practice, Medicinal Products for
Human and Veterinary Use, Chapter 4:
Documentation
 USP-41, 2018-General Notices, Page: 09,Volume-01
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ATTITUDE
 Every problem has a solution, only if we
perhaps change our ATTITUDE.
 ATTITUDE is everything.
 It is our ATTITUDE towards LIFE
and WORK that makes our life
100%
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ATTITUDE
 A- 1
 T
- 20
 T
- 20
 I- 9
 T
- 20
 U- 21
 D- 4
 E- 5
= 100
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ATTITUDE
 Excellent Facilities Negative Attitude Poor Quality
 Excellent Facilities Positive Attitude Good Quality
 Limited Facilities Positive Attitude Maximizing
Efforts Good Quality
So in conclusion can say, Good quality can‟t be achieved without
positive attitude
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 Never use obsolete documents.
 Unsigned documents or records should not be
used to perform any task.
 Do not use the page/sheet which are already faded
and not properly photocopied.
 Do not use scrap paper or sticky notes for
recording the data.
 Do not remove/replace any page or original data
from the recorded document or from the
imported devices.
Good Documentation Practices
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 Don‟t use Ditto ( ̎ ) sign. Give similar information in
the space provided instead of putting ditto ( ̎ ) of any
documents.
Examples:
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Incorrect Way Correct Way
Silmon10 Tablet box of thirty is 420.00 TK
Sifena 120 ̎ ̎ ̎ fifty ̎ 350.00 ̎
Duet ̎ ̎ ̎ ̎ 204 ̎ 510.00 ̎
Silmon 10 Tablet box of thirty is 420.00 TK
Sifena 120 Tablet box of fifty is 350.00 TK
Duet Tablet box of two hundred four is 510.00 TK
GDocP

 Don‟t draw single line instead of putting
signature in each and every column/row of any
documents.
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 Don‟t use stamped signature in lieu of
handwritten signature.
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USE INDELIBLE INK
 Fill out record in indelible ink for long term
legibility.
 Use blue ink (ballpoint pens) for entry in
GMP documentations e.g: SOP, STP, BMR and
BPR etc.
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 Do not use pencil or ink that can be
erased.
 Do not use correction fluid.
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Critical steps must be independently checked
(4 eyes principle)
Four-eyes principle:
The four-eyes principle means that a certain activity,
i.e. a decision, transaction, etc., must be approved
by at least two people.
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 Make a single line through the error
Recorded entries are not erased, obliterated,
covered up, crossed out written over, or otherwise
destroyed such as the original entry cannot be
determined. Documentation errors or mistakes
are corrected using the C.L.I.D.E. method:
a) Correct
b) Line through the complete erroneous entry (single line)
c) Initial
d) Date
e) Explain
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C.L.I.D.E. method:
a) Correct
b) Line through the complete erroneous
entry (single line)
c) Initial
d) Date
e) Explain
853.786
853.768
Remarks: Recording error
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C.L.I.D.E. method:
For example
 Transcription Error (e.g. Transcr. Err)
 Recording Error (e.g. Rec. Err)
 Technical Error (e.g. Tech. Err)
 Wrong Date (e.g. Wr. Data)
 Late Entry
 Translocation Error (e.g. Transl. Err)
 Spelling Error (e.g. Spel. Err)
 Calculation Error (e.g. Cal. Err)
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 When you have done any task you should be
put on sign with date.
Delegate responsibility to another qualified
person in absence of key member of
employee or staff by issuing an
authorization letter/ circular signed by the
member and/ or a more senior member of
staff.
Use tick (√) symbol in front of signature of
the signatory person.
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Page number
Use page number in Documents
following standard ‘X of Y’ to indicate
the total number of pages in a
document. e.g. 1 of 2.
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GDocP

DATE FORMAT
Record dates following common practice
of the country such as Day/Month/Year.
For example –
14/03/22
or
14/03/2022.
Give sign with date. If date is present in
that column or row give only signature.
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Recording Time :
 Military time: (24 hour format) two (2) digits to indicate the
hour (00 to 23) followed by two (2) digits to indicate eh
minutes (00 to 59)
Example 0850 and 1750, 08:50 and 17:50
 Meridian time: One or two digits to indicate the hour (1 or
12) followed by two digits to indicate the minutes (00 to 59)
then the morning (AM) or afternoon (PM) designation.
Example 8:50am or 5:50pm
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Completing all fields on a record
Mark out the multiple blank
spaces/rows/columns on a record with a
single line cross (from left upper corner to
right lower corner) or Z type marking the
whole field/space, enter ‘Not required’
/ Not Applicable (N/A)’ with sign & date.
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Correct Marking
Incorrect Marking
N/A
N/A
(left upper corner to right lower corner)
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Correct Marking-(Z marking)
N/A
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Fill up remark option or comment option of
the document with appropriate writing such
as OK, Satisfactory.
Time Hardness Checked by Remarks
6:10AM 5.25KP
OK
7:00AM 6.15KP
OK
8:15AM 7.20KP OK
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Fill up remark option or comment option of
the document with appropriate writing such
as OK, Satisfactory.
Comments on yield, documentation and deviation
Comments of Production Executive
OK/Satisfactory
Checked by
Comments of Head of Production
OK/ Satisfactory
Comments of Head of QA
OK/Satisfactory
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Rounding of Rules
 If this digit is smaller than 5, it is eliminated and the
preceding digit is unchanged. If this digit is equal to or
greater than 5, it is eliminated and the preceding digit is
increased by 1.
 Do not round the value of machine print out.
 Do not round a number until final calculation for the
reportable value has been completed.
 Round the intermediate calculations for reporting
purposes, but the original value should be used for any
additional required calculation.
 Acceptance criteria are fixed numbers and are not
rounded.
 When rounding is required, consider only one digit in the
decimal place to the right of the last place in the limit
expression.
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Rounding of rules:
Illustration of rounding numerical values for comparison with
requirements
Compendial
Requirement
Unrounded
Value
Rounded
Result
Conforms
Assay limit ≥98.0% 97.96% 98.0% Yes
97.92% 97.9% No
97.95% 98.0% Yes
Assay limit
≤101.5%
101.55% 101.6% No
101.46% 101.5% Yes
101.45% 101.5% Yes
Limit test ≤0.02% 0.025% 0.03% No
0.015% 0.02% Yes
0.027% 0.03% No
Limit test ≤3 ppm 3.5ppm 4 ppm No
3.4ppm 3 ppm Yes
2.5ppm 3 ppm Yes
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STAFF SIGNATURES/INITIAL
Signature is to be used, for signing any approval, authentication
of any document. Such as: Standard Operating Procedure
(SOP), Standard Testing Procedure (STP), Batch Manufacturing
Record (BMR), Batch Packaging Record (BPR), Bill of Material
(BOM), Quality Manual, Site Master File, Validation Master Plan,
Regulatory documents, Certificate of Analysis (COA), Different
Labels, Under Test, Sampled Slip, Quarantined Slip or Wherever
‘signature’ is mentioned.
Initial can be used in regular routine checks (e.g. In-
process control papers or wherever ‘initial’ is mentioned).
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LEGIBLE HANDWRITTEN ENTRIES
Ensure the handwriting is legible.
Make the entries at the time the tasks are
performed and will be legibly signed and
dated.
Entry data within the assign space. If there
is space constrain in the specified area,
put asterisk (*) mark on the top of the
entries and put necessary information at the
bottom where the space is made available
with signature and date.
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Time Hardness 3
tablets
6:10AM 5.25KP, 7.15KP *
* 6.85KP
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Use front side of the page to record all
information and don’t use the opposite
side of the page. Use additional page if
required with proper signature & dated by
QA person through raising a request
form.
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MACHINE PRINTOUT
Staple the attachment to the record (any printout);
paperclips are not acceptable.
Put sign and date on any machine print out.
Copy all thermal paper printouts in Normal
Paper (A4 size preferably) before attaching to a
report or filing (data to rapidly fade).
Secure the original and the copy with the report,
after making a copy.
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.
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Don'ts
 Don‟t type in results (write in ink).
 Don‟t use fluid for correction.
 Don‟t use obsolete documents.
 Don‟t use the page/sheet which are already
faded and not properly photocopied.
 Don‟t leave any empty result boxes.
 Don‟t use single line instead of putting signature
in each and every column/row of any
documents.
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Don'ts
 Don‟t use stamped signature in lieu of
handwritten signature.
 Don‟t use pencil that can be erased.
 Don‟t forget to initial and date results
when you write them down (for each
line).
 Don‟t report results as “as expected” or
“conforms”.
 Don‟t use Ditto (‟‟) marks.
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Do‟s
 Do cross out any mistakes with a single line.
 Do use „C.L.I.D.E‟ method for correction of errors
or mistakes.
 Do put on sign with date when you have done any
task.
 Do use blue ink (ballpoint pens) for entry in GMP
documentations.
 Do check (4 eyes principle) for critical steps.
 Do use page number in documents following
standard „X ofY‟.
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Do‟s
 Do use record dates following common practice
04/04/19 or 04/04/2019.
 Do use „single line cross‟ or „Z type marking‟ in blank
spaces/rows/columns
 Do fill up remark option or comment option with
appropriate writing such as OK, Satisfactory.
 Do put sign and date on any machine print out.
 Do copy all thermal paper printouts.
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Documents & Record-keeping
Two fundamental rules for recordkeeping in GxPs:
Rule #1
“ If it’s not documented, it wasn’t
done. ”
Rule #2
“ If it’s not signed and dated, it’s
not documented. ”
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A Famous Proverb Says-
“IF YOU HAVE NOT
DOCUMENTED AN ACTIVITY,
YOU HAVE NOT DONE IT”
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