GOOD DOCUMENTATION PRACTICES

(GDP)

R. SURESH
What is being made?

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Documentation

• Most of us when attempting a task need some sort of

documentation
• A large part of GMP involves written instructions, following
those instructions and making records.

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Documentation

• Documentation enables us to investigate complaints,

failures, problems and trend analysis and as a
tracker.
• Documentation helps us decide on, and take, any
necessary corrective action.
• Another reason for documentation is that it helps to
build-up a detailed picture of what a company has done
in the past and what it is doing now.
• Documentation is a mandatory regulatory requirement
• Finally as per GMP “if it is not documented it is a
rumour”.

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Documentation

• Documentation is an essential part of QA and relates to

all aspects of GMP
• A reliable evidence for GMP compliance
• The system of documentation devised or adopted should
have as its main objective to establish, monitor, and
record “quality” for all aspects of the production, quality
control and quality assurance

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Purpose of Documentation
• Clearly written documentation prevents errors that may arise in oral
or casually written communication
• It provides assurance that quality related activities are carried out
exactly the way they have been planned and approved
• The achievement of conformity and quality improvement
• Good documentation, on the other hand, conveys a message of
intelligence, sincerity and professionalism
• Purpose of documentation :
 To ensure that there are specifications for all materials and methods
of manufacture and control
 Employees know what to do
 Responsibilities and authorities are identified
 Ensure that authorized persons have all information necessary for
release
 Provide audit trail
 Forms the basis for improvement
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 QUALITY SYSTEM
DOCUMENTATION

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Quality System Documentation

• Documentation is the key to operating a pharmaceutical

company in compliance with GMP requirements.
• All the elements, requirements and provisions adopted
by pharmaceutical company for its quality system should
be documented in a systematic, orderly and
understandable manner in the form of policies and
procedures.
• Documents should be designed, prepared; reviewed and
distributed with care.
• It should be written in detail and in simple language that
can be understood by the user.

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Quality System Documentation

• Informative

• Prescriptive

• Historical

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Quality System Documentation
• GMP documentation includes:
– Quality manual
– SOPs
– Annexure to Core SOP
– Guideline (Company specific)
– Form:
• Specification and method of analysis.
• Master formulae.
• Process flow sheets.
• Batch records.
• Training records.
• Protocols and reports.
• Records (related to change control, deviation, incident, complaint, recall,
returned goods, internal audits, qualification/ validation activities, register,
log, labels, status board, check list, job responsibilities etc.)
– Raw data which include the documents other than specified in above

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Quality System Documentation
• Raw data includes:
– Any laboratory worksheets, records, memoranda, notes, or exact copies
thereof, that are the result of original observations and activities of a
study and are necessary for the reconstruction and evaluation of the
report of that study.
– Raw data may include photographs, microfilm or microfiche copies,
computer printouts, magnetic media, including dictated observations,
and recorded data from automated instruments.
– All data generated during the conduct of a study, except those that are
generated by automated data collection systems, shall be recorded
directly, promptly, and legibly in ink.
– All data entries shall be dated on the date of entry and signed or
initialed by the person entering the data.
– Any change in entries shall be made so as not to obscure the original
entry, shall indicate the reason for such change, and shall be dated and
signed or identified at the time of the change.

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 FORMAT OF DOCUMENT

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Format of Document
 No “best format” in documentation system.
 Each document should be suitable for all users
 In general, all quality documents can be written in the
following format :
 narrative
 flowchart
 combination narrative and flowchart
 electronic / computerized system
 Photographs can be documents provided they are
properly authorised and controlled

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Narratives Document
 The most common format being used
 The narrative document can be described as the
following :
 Policy reference
 Objective : why and for what
 Coverage area
 Document reference
 Responsible person
 Detail procedure
 Record if needed

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Flow Chart Document

 Schematic
representation which
describe the flow of
processes in certain
target activity
 Very clear and easy to
read
 Sample of the
flowchart document
can be written as
beside schema
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Combination Document

Sometimes narrative document & flowchart is

supported by design / lay out
Legend
1 = Mixer
2 = Intermediate bin with activated discharge
3 = Feed metering unit
4 = Metal separator
5 = UPZ fine impact mill with pin discs
6 = UPZ fine impact mill with pin discs
7 = Automatic reverse-jet filter
8 = Fan
9 = Rotary valve
10 = End-product bin with activated discharge
11 = Bagging unit
12 = Control cabinet

A = Feed product
B = material addition
C = End product
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Electronic Document

 Geared towards assuring data integrity of computerized

systems used to meet predicted rule requirements
 Using ERES (Electronic Records; Electronic Signatures)

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 HOW TO CREATE
GOOD DOCUMENTATION SYSTEM

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 Document
1. Document is :
 complete history of each batch
 from starting materials to finished products
 record activities for :
• maintenance
• storage
• quality control
• primary distribution
• specific matter related to GMP
2. Documents should be designed, prepared, reviewed
and distributed with care
3. All documentation must be organized into files which
must be maintained for specified periods of time after
the expiry date of the product.
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Content of Document

What should be written in the document:

• Name of document
• Name of company, department or division of the maker
• Document number
• Page and number of pages of document
• Number of revision
• Date of approved
• Name and signature of the person who prepared the
document
• Names and signatures of the person who reviewed and
person approved the document
• Body of document
• Document receiver

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Numbering System

 Every document should have a number from the Control

Division
 Document numbering system should be made, to make
easy on saving and controlling the document

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Document Control

• Documents should be dated and authorized

 approved, signed and dated by appropriate
authorized persons
 no document should be changed without
authorization
• All document records should be completed as the
process proceeds.
• Distribution list of documents should be recorded
• Obsolete documents should be :
 taken from users , based on distribution list
 marked “obsolete” and archived
• Create a list of running documents , centralized
• Use only updated documents
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Document Distribution

 Distribution of documents should be the up-to-date

documents
 Copy of documents should be distributed to relevant
parties
 The list of distribution should be made
 Document Data Control Division or QC can distribute the
document
 Main document should be received by Production and
Quality Control Department
 Supporting document is distributed to related division
only

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Revision & Renewal

 Should be made periodically, or if needed

 Obsolete documents should be retrieved from all
relevant parties and its original copy should be
archived
 The date of revision should be stated in the new
documents
 Every revision should be approved by authorized
person

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 GOOD DOCUMENTATION PRACTICES

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Four Golden Rules on Proper Documentation

• 1. If it isn’t written down, it didn’t happen.

• 2. If it isn’t written down correctly, it didn’t happen either.

• 3. If it can’t be understood, it wasn’t documented.

• 4. Don’t forget Rules 1, 2 & 3.

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 Think….before you document!!

In spite of workload & tight work schedule……

Be sure that you have understand &written

correctly!!

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 Always fill in the blanks

 Record all requested information, Do not

keep it blank.
 If it’s truly not applicable, write ‘NA’ with
your initial s &date .
 If pages or sections of forms are not
applicable ,line through them &write ‘NA’
with your initials &date ,wherever required
state the reasons.

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Use indelible ink

• All the entries should be made by using

black/blue permanent indelible ink because it
photocopies well and does not smear.
• Pencil &water soluble inks are unacceptable
because it smears easily & can be erased.
• Green ink pen can be used by QA for getting
clear view of verification.

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“Practice to do on-line documentation, record
result as you get them”.

Common GMP error is to speed through the

document at the end of the day or at the end
of the shift, filling in all the blanks records
at one time.

Because it is a fact that it is impossible to

remember all what we did five minute ago
and much is missed eight hours back.

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Whitener or correction fluid not permissible

• Do not alter or overwrite letters or numbers, all

entries should be legible, write or print always
clearly.

• The correct way to make the corrections or

editorial changes is to line through the error
once and put initial & date all corrections.

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….signature is a legal & ethical Responsibility
• Before signing anything, check for the accuracy,
completeness & correctness of the text/calculation.
therefore you must ,to the best of your ability, review
the document thoroughly & completely.
– Make sure that everything that needs to be attached is
attached.
– Never sign something that you know to be wrong, get it
corrected and signed by concern person.
– Never sign the document with which you are not aware of.
– Never correct the error which was committed by other
person.
– Provide the explanation for the corrected error where it is
required.
– Put the date below signature as far as possible.
• One who sign is fully responsible for it …..
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…Never do backdate or falsify records !

• Always use current date when documenting your work,if

you do not ,You are falsifying records.
• Always use approved format for documentation.
• Adopt format for documenting date & time as per SOP.
E.g.:
DD-MM-YY (for other than effective dates)
DD-MM-YYYY (for effective dates)
• Time as 24 hrs, clock such as 23:01 Hrs.
• Use rounding of numbers or decimals as per SOP policy.

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Good Handwriting

• Definition - The sentences written in a clear,

uniform & legible manner so that it is
readable understandable to all.

• It shall be written in a straight line with

correct word spacing & using correct form of
sentence case.

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When affixing supporting documentation to a
page ,special care may be needed….
o Use appropriate size & color of paper.
o Check that large size paper is properly folded to a
desired size.
o Check that all the attached document shall align
properly.
o If it more than one sheets, use binder, folder or staple it,
but never use paper clip or U-pin ,tape or glue.
o Always do indexing for the attachments if more than one
sheets are attached.
o Do sing& date for correctness on each attachments.
o Always verify the documents received from the external
agency before attaching.
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Comment & clarifications should be
FACTUAL,CONCISE & TRACEABLE!

o Be factual… State fact, not supposition.

o Concise… Be descriptive yet brief.

o Traceable…Easily tracked within the document

or to related records.

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Record data directly on the appropriate format
or notebook
o Do not write original data on scrap paper, hand or paper
towels and then transfer to format or notebook.
o Always attach printouts and labels where indicated.
o Never missed original data or documents.
o Use additional page or sheet when more space is
needed given appropriate identification number.
o Finally original information or data should not be lost &
manipulated.

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All Documentation errors require correction!

o Corrections must be legible, never cross

obliterate an entry by use of correction tape or
white fluid.
o Use asterisk or star or circle number to the error
correction to item being corrected.
o Correction made after review require re-review.
o Correction made after verification require the
verifier be present when correction is made.
o Write the reason for correction as close to the
error as possible.

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Data Correction

 16.35 → 16.55







If there is a mistake, neatly cross it with single line, do the correction, keep initial and date.
Also indicate the reasons for correction.
 Ditto marks to indicate “all date or data in a
column are the same” are not allowed.

Arrowing down or across to indicate data are

the same is not allowed.

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Please note!

o “Checked by” or “Reviewed by” cannot be

signed prior to the “Done by” sign.
o The same person cannot sign both “Done by” &
“Checked by”.
o Department responsible for the activity should
sign at designated place provided.
o No other department /person can sign on behalf
unless authorized.
o Pages or blank columns can be pre-signed.

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Please remember !

o Signing for someone else in the same

department only.
o For the planed absences, one person may give
permission to another to sign in their absence.
o The signer will list the person they are signing
for and then affix their own signature & date.
o Behalf signature for the junior can be allowed
but not senior without official authorization.

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Good Documentation Practices

* Permanent * Truthful
* Legible * Traceable
* Accurate * Complete
* Clear * Consistent
* Timely

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REMEMBER

If you have a question – Ask

If you don’t understand the instruction –Ask
If you aren’t sure who is responsible – Ask
If it’s your responsibility – make sure it get done
properly.

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Roles & Responsibilities.

The performer /Doer :The individual executing each step

in the set of instructions.
The Verifier :The second qualified individual responsible
for witnessing the steps or evaluating a calculation,
results to ensure the procedure is followed and
documented appropriately ,accuracy in real time.
The reviewer : A supervisor or other qualified individual
responsible for reading the documentation. He is
responsible for ensuring that all appropriate procedures
have been followed and documented in correct and as
per the Standard policy and area of specification.

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 Conclusion…

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Did we achieve today’s training Objectives?

• Requirements of cGMP documentation

• What is Good documentation?
• Importance of GDP .
• Is there Good and bad documentation?
• Examples of good & bad documentation.
• Current issues

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Record Keeping Rules
“Do Not” Rules
 DO NOT scribble out mistakes (obscures entry)
 DO NOT write correct entries over incorrect entries
(writing over obscures original entries)
 DO NOT forget to enter all required info
 DO NOT forget to initial and date entry
 DO NOT use colored ink/pencil
 DO NOT leave mistakes uncorrected (check your
entries)

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Train the Trainer – L&D

Module Outcome
Making the participants to understand there are different
Module 1 : learning styles and if we call 15-20 people they learn things in
Learning styles/Adult Learning
1hr their own way. What all things a Trainer must consider?

Helping the participants to understand what are the

Module 2 : competencies a Trainer need to have. This will help them to
Trainer competencies understand which of their competences will be helping
1 hr
them to become a good trainer. competencies
This will help the participants to understand the essential
Module 3 : components of a module and what must be the
Designing a Learning Solution
1 hr sequence.

The module help the participants to understand the importance

Module 4 : of involving the people while conducting a training session.
Facilitation & Accelerated learning
techniques 1 hr

The practise session will help to learn how effective, useful

Module 5 : Practise sessions
3hrs & practical the above techniques are.

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Thank you for your
attention!