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Training Program on
Good Documentation Practice
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Good Documentation Practice
Introduction: Good Documentation Practice
Good documentation practice GDP is a systematic procedure of preparation,
reviewing, approving, issuing, recording, storing and archival of any
document.
Good Documentation Practice
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Introduction: Why Good Documentation is essential
An essential part of quality assurance system and should exist for all aspect of GMP.
Good Documentation practice is regulatory requirement based on ICH Q7.
As per GMP "If it is not written down, then it did not happen".
The document provides information on when, where, who, why and how to complete the task.
The document provides evidence proving that the tasks have been completed as they should be.
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Good Documentation Practice: Applicable Guidelines
ICH HARMONISED TRIPARTITE GUIDELINE
GOOD MANUFACTURING PRACTICE GUIDE FOR
ACTIVE PHARMACEUTICAL INGREDIENTS
Q7
Section 6
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Good Documentation Practice: Regulatory Prospective:
ICH Q7
A
t Coral Drugs Pvt Ltd
Section 6.1
All documents
related to the manufacture of
intermediates or APIs should be prepared, reviewed,
approved and distributed according to written
procedures. Such document can be in paper or
electronic form
.
Preparation,
review ,approval and distribution of
documents are executed through Procedure for
document and data control (Section 6.2 to 6.3)
(
SOP#CDPL/SOP/QA/015/08)
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ICH Q7
A
t Coral Drugs Pvt Ltd
Section 6.1
A Procedure
should be established for retaining all
appropriate documents.
All appropriate
documents are retained as per the
Procedure for document and data control (Section
6.9) (
SOP#CDPL/SOP/QA/015/08)
Good Documentation Practice: Regulatory Prospective:
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ICH Q7
A
t Coral Drugs Pvt Ltd
Section 6.1
All production,
control, and distribution records
should be retained for at least 1 year after the expiry
date of the batch.
Executed
batch production records, analytical data,
equipment / instrument usage log book,
miscellaneous batch supporting documents, training
records, change control, market complaint, OOS,
deviation, APQR etc. are retained up to 1 year after
the product expiry or 6 year which is more.
Procedure for document and data control (Section
6.9.2) (
SOP#CDPL/SOP/QA/015/08)
Good Documentation Practice: Regulatory Prospective:
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ICH Q7
A
t Coral Drugs Pvt Ltd
Section 6.1
During the retention period, originals
or copies of
records should be readily available at the
establishment where the activities described in such
records occurred..
During the retention period,
originals or copies of
records should be readily available at the place where
the activities described in such records occurred.
Procedure for document and data control (Section
5.1) (
SOP#CDPL/SOP/QA/015/08)
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ICH Q7
t Coral Drugs Pvt Ltd
Section 6.1
When entries are made
in records, these should be
made indelibly in spaces provided for such entries,
directly after performing the activities, and should
identify the person making the entry. Corrections to
entries should be dated and signed and leave the
original entry still readable.
e time when work is performed with date and
SOP#CDPL/SOP/QA/047/06)
Good Documentation Practice: Regulatory Prospective:
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Let us Discuss….!!!
Good Documents Practices in details….!!!
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• Preparation, Reviewing, Approving, issuing, recording, retaining and archiving etc. of documents in
controlled manner with maintenance of adequacy and revision history.
• Changes & current revision status of documents should be identified.
• Relevant versions of applicable documents should available at points of use.
• Documents of external origin should be identified and their distribution controlled
• Unintended use of obsolete documents, and archiving should be avoided.
What Constitutes Good Documentation?
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• Primarily GDP is maintained through these three procedures:
• SOP#CDPL/SOP/QA/000/09 SOP for writing, review, approval, distribution, control and revision of SOP.
• SOP#CDPL/SOP/QA/015 Procedure for Document and Data Control.
• SOP#CDPL/SOP/QA/047 Procedure for Good Documentation Practices
Applicable Procedures
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• Missing signature and dates at the time of activity performed.
• Blank space
• Document error correction not signed/dated, and didn’t include a reason for the correction.
• Write-overs, multiple line-through and use of “White-out” or other masking device.
• SOP related to production, calibration, storage and maintenance not authorized by QA head.
• The delegation for the batch release, in case of absence of the QA manager, not recorded / documented.
• Out-of-specification (OOS) procedure not detailed enough; flow chart and /or check-list not available.
Observations on Poor Documentation Practices
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• People don’t understand What & When to document.
• Procedure may not be completely understood or followed.
• Responsibility may not be clearly defined.
• Lack of understanding for legal role of documentation.
• People may not be properly trained.
Why do people sometimes fail to document and activities or event properly?
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• Records should be completed at time of activity or when any action is taken.
• Superseded documents should be retained for a specific period of time.
• Records should be retained for the period base on type of documents.
• Period 1 : Life time
• Period 2 : one year after product expiry or six year whichever is more
• Clear examples.
• Don’t assume knowledge.
Some tips on Good Documentation Practices
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• Use Blue Color ball pens only for hand written entries.
• Do not use pencil for making entries
• Blank space should not left. Use NA in case of ‘Not applicable’
• Hand written entries should be made in clear, legible, indelible way
• Never use lines (with or without arrows) to show a continuation of values or entries in a column or row.
How to write correctly
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• Right way to write date is DD/MM/YY (OR) DD/MM/YYYY
• Where:
• DD stands for Date
• MM stands for Month
• YY/YYYY stands for Year
• Date : 18 March’2016
• Right way : 18/03/16 (OR) 18/03/2016
• Date shall be changed after completion of 24 h (00.00 h)
How to write correctly
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• Right way to write time is HH : MM
• Where:
• HH stands for Hours
• MM stands for Minutes
• Time: 5:20 P.M.
• Right way: 17:20
How to write correctly
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Correct usage of Abbreviation for SI-metric units and other units :
Few examples :
Correct Usage
• Kilogram : kg
• Gram : g
• Hours : h
• Second : s
• Milliliter : mL
How to write correctly
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Avoid sloppy writing
What’s that number?
Is it 27? 29? 24? 2%
How to write correctly
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• Suppose this is final product results, and the specification says 27 through 29 is acceptable. Well, if it’s
27 or 29, then we’re in good shape. It meets our specification.
• But what if it’s 24? Now what?
• We might have to reject the entire experiment.
• Maybe we can take additional samples and test it again.
• That will take time and resources.
How to write correctly
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• Enter detailed, complete and accurate information at the time work is performed.
• When one or more person complete a task, all must sign.
• Never sign your name for performance of a job for work actually performed by someone else.
• Enter enough details so the document can be clearly understood in the future.
• Review of documents should be after completion of documents.
How to write correctly
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• NEVER USE “correction” liquid, tape, or material.
• Draw a single line through the error.
• Make the Correction next to the error.
• Write an explanation for the error (if applicable).
• Sign and date the correction.
Weight of ingredient 14.5 kg MA 10/01/15 14.75
Don’t Deface the original Entry!
How to mistake corrected
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How to mistake corrected
Error Description
• The following are the example of notations that may be used to describe error corrections.
• Calculation error
• Illegible entry
• Scale zero error
• Non-calibrated instrument
• Wrong instrument
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• Bound notebook pre-numbered should be preferred.
• In case of loose sheets; It should pre-numbered; have controlled printing and storage provision.
• If a notebook is no longer used and unused pages are remaining:
• Draw a line across the first unused page.
• Indicate “the remainder of the note book is not used”
• Sign with date.
Control of Documents
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• Computer print outs taken on thermal paper or easily fading inks should be photocopied and maintained.
• Original shall be destroyed after verification
Use polyvinyl alcohol base gum or white
glue for pasting of graphs etc
How to retain documents correctly
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• Use clear transparent tape for mending (patch-up).
• Don’t remove any pages or portions from a note book
• Don’t make any temporary entries in a bit of paper of hand
• Preserve the notebooks intact.
How to retain documents correctly
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• Storage of documents must be at secure place, with access limited to authorized persons.
• Documents must be identified.
• Active documents and Obsolete documents should be kept separately.
• Document must be arrange in such a way that it is easy retrievable.
Document Retrieval
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