The document discusses good documentation practices for quality control laboratories. It addresses the purposes of documentation including defining specifications and procedures, ensuring personnel know proper processes, and providing traceability. Key features of good documentation include legibility, conciseness, accuracy, and accessibility. Common documentation errors like missing signatures and dates can negatively impact quality assurance. Maintaining good documentation practices provides benefits such as unlocking individual potential and building confidence in product quality.

1. Phr. Bholakant raut
Quality Control Officer
Bachelor in Pharmacy, NPC Regd. No: G 1997
TIME Pharmaceuticals (P.) Ltd.
Good Documentation Practice (GDP)

2.  Introduction
 The purposes of Good Documentation (QC Laboratory)
 Key features of good documentation
 Why good documentation is essential?
 Types of Documentation (forms)
 Documentation Pyramid
What constitutes Good Documentation? (GDP)
 Common Documentation Errors
 Benefits of good documentation
 Conclusion
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The document is information (meaningful data) and its supporting medium, which
could be in paper form, CD, computer files, or microfilm. Document provides
information or evidence or may serve as an official record.
Documentation is an integral component of GMP and the quality management system.
It is also key to GMP compliance for it ensures traceability of all development,
manufacturing, and testing activities.

4. Documentation provides the route for auditors to assess the overall quality of
operations within a company and the final product.
Documentation is a professional skill, as important as other skills
Can make you look professional or unprofessional….you decide
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To define the specifications and procedures (SOPs) for the analysis of excipients,
active ingredients, products and handling of equipments and machines.
To ensure that all personnel concerned with quality control tests know what to do and
when to do it.
To ensure the existence of documented evidence, traceability, and to provide records
and an audit trail that will permit investigation.
And to ensure the availability of the data needed for validation, review, and statistical
analysis.

6. Legible: Everyone should be able to read what is written regardless of who, where or
what has been written.
Concise: The document must provide clear information that is understood by all officers.
Traceable: who recorded it, where, when and why ?
Accurate: Documentation should be error-free―properly reviewed, verified and
approved.
Contemporaneous: The information should be documented at the correct time frame
along with flow of events.
Enduring: Long lasting and durable.
Accessible: Easily available for review.
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7. In a GMP environment documentation needs to meet certain requirements to ensure
product quality and product safety.
If an instruction or record is poorly documented, then the manufacture or Quality
assurance/control of a product can be negatively impacted, potentially reducing patient
safety.
“GDP describes the standards by which documentation is Created and Maintained in the
pharmaceutical industry”
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8. The GMP regulations include mandatory sections on documentation. Documentation
provides both:
Information on when, where, who, why and how to complete tasks, and
Evidence proving that the tasks have been completed as they should be.
Consequently, the standard 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.
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9. A. Documents – procedural or instructional documentation
Examples are: Training schedules, change Control documents,
Calibration form, Temperature & humidity Chart, CAPA, Daily
Plans, Emergency repair & maintenance form, SOPs etc.
Benefits:
 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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10. B. Records – evidence of compliance
Examples are: Humidity and temperature control records, Calibration records,
Emergency & maintenance records, Training records, BMRs, Log Books
Benefits:
 Provide background history
 Protects intellectual property (Evidence of an idea or a finding including the date
and the responsible person)
 Provide legally valid evidence
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11. The documentation structure for ISO 9001:2008 typically looks like this
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For example, a policy statement could be: All personnel
involved in calibration and testing should be competent for the
assigned task.
For example, it describes how the requirement ‘Personnel
should be competent for the assigned task’ can be implemented.
Standard operating procedures (SOPs) or Working Procedures
are step-by-step instructions for how to exactly perform a
specific task, such as calibrating a specific instrument.
Records are generated on a day-by-day basis, such as analytical
results from product tests or calibration records of a balance.
They are used to provide traceability of actions taken on a
specific product or batch of products.

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Types of
Documents

13. The laboratory should establish and maintain procedures to control and review all documents (both internally
generated and from external sources) that form part of the quality documentation. A master list identifying the
current version status and distribution of documents should be established and readily available.
FDA statement should drilled into you from day one:
On one hand to the work, on other make the document (Document each step before moving to next). All
documents must be accurate & written in a manner that prevents errors and ensure consistency.
Proper identification, collection, indexing, retrieval, storage, maintenance, and disposal of all quality documents.
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14. Never overwrite or scribbled the entry. Making a Legible Correction:
i. Draw a single line through the error,
ii. Make the correction next to the error,
iii. Write an explanation for the error,
iv. Sign and date the correction.
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15. Use indelible (water- resistant/ permanent) black ink, ball-point ink
Never use white ink to remove error
Do not use pencil or felt-tipped marker
Never leave space or blank in the document and draw a diagonal line through any blank fields or empty
spaces at the bottom of a page and include ‘N/A’ along with your initials and date.
NEVER Back date.
When entering repetitive data, do not use DITTO marks.
Forget the syndrome “We can fix the documentation later…………”
A stamp in lieu of a handwritten signature is not acceptable.
 Critical entries must be independently checked (second person verified)
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16. Handwritten signatures must be unique to the individual and listed within the site signature register
to ensure that the signature is traceable to a member of staff. Signatures must never be forged. In the
event that a critical member of staff is absent for a time, they must delegate responsibility to another
qualified person.
 Documents must be approved for use. They must be approved, signed, and dated by appropriate
authorized personnel. Data integrity and security shall be maintained.
 Records should be made or completed in the personal activity log book at the time each action is
taken and in such a way that all significant activities concerning the QC tests of raw materials and
products are traceable.
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A system of change control should be in place to inform staff of new and revised procedures. Staff
should acknowledge by a signature that they are aware of applicable changes and their date of
implementation.
Appropriate, authorized SOPs should be available at the relevant locations, e.g. near instruments
Archived documents must be retrievable for the appropriate duration
Documents should be regularly reviewed and kept current,
Documents should be retained and readily available for audits

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When electronically produced, the documentation must be checked for accuracy.
Electronic records must be backed up. Backed-up data should be retrievable and stored in such a
manner as to prevent data loss.
All quality and technical/scientific records (including analytical test reports, certificates of analysis
and analytical worksheets) should be legible, readily retrievable, stored and retained within
facilities that provide a suitable environment that will prevent modification, damage or
deterioration and/or loss.

19. COMMON DOCUMENTATION ERRORS
• Documentation not contemporaneous
• Missing signature and dates at the time of activity performed, e.g. missing of date and signatures in
data entry logbook at the time of weighing of samples/standards, performing IPQC tests etc.
• Incomplete report e.g. missing of signature, date, standard limits in analysis sheets and references
in final reports etc.
• Non-uniform date and signature
• Illegible writing and too many corrections, write- over
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20. BENEFITS OF GOOD DOCUMENTATION
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 Unlock the potential of individual using the document
 Amplify the value of the product
 Build confidence in the quality of product
 Good documentation helps to save the papers
 Reduce the efforts to compliance with regulatory bodies
 Good documentation enables to achieve the results that you are seeking for.

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23. 1. WHO good practices for pharmaceutical quality control laboratories, Annex-1, WHO
Technical Report Series, No. 957, 2010.
2. http://www.ivtnetwork.com/article/good-documentation-practices
3. http://www.qmrs.com/work/services/4%20GDPs%20new.htm
4. http://www.labcompliance.com/tutorial/iso17025/
5. http://www.textlogic.ch/en/blog/writing-policies-and-procedures.html
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24. "Quality never comes accidently, it
comes by practice".
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