Good Documentation Practice (GDP)

Prepared By:
Najam-Us-Sahar
M.sc(Applied Chemistry & Chemical Technology)
Good Documentation Practice (GDP):
Good Documentation Practice (GDP) is a systematic procedure of
preparing, reviewing, approving, issuing, recording, storing and archiving of
documents. GDP describe standards by which documents are created and
maintained.

Raw Data:
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 computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments (21 CFR 58.160.3 (7)).
Objectives:
➢ Ensures Complies with regulatory requirements.
➢ Provides control of processes and improves performance.
➢ Enables important messages to be communicated clearly and
accurately
➢ Ensures reliable, consistent transfer of information.
➢ Ensures product quality and safety.
What Are Good Documentation Practices?
Good Documentation Practices, commonly referred to as GDPs, are the guidelines
that one follows in recording information in a legible, traceable and reproducible
manner.
A key to Good Documentation Practices is to consider these questions
each time you record your raw data:
• Is it attributable?
• Is it legible?
• Is it contemporaneous
• Is it original?
• Is it accurate?
What is ALCOA?
Raw data should include these attributes:
➢ Attributable
➢ Legible
➢ Contemporaneous
➢ Original
➢ Accurate
Better known as ALCOA.
 Attributable
Documentation should provide information on:
– what activity is being documented,
– who is performing the activity,
– materials and equipment used in the activity, as well as
– the activities preceding and following the activity.
• Documentation should be traceable to the individual(s) performing an activity.
Signatures and Initials:
Signatures and/or initials on a document indicates that:
• The individual is authorized to perform, verify, review and/or approve the
activity he/she signed for.
• Confirms your unique identity (signatures/initials should be authentic and
traceable to a specific individual).
• Sign and/or initial for yourself only. Never allow someone to sign or initial any
document for you, unless that person is authorized in writing to do so and
according to procedure.
• A signature and/or initials is not valid without a date. Dates should be
documented at the time of signing any record. Multi-page data capture
documentation should have attribution on each page.
 Example of "Attributable" in Pharmaceutical GDP:
Scenario: An analyst performs a pH test on a drug product and records the
result in a logbook.

(Correct Attributable):

Date Time Product Batch # pH Temperature Performed By

Name

02-June-2025 10:45 AM Cutis spray 031 2.67 25.1°C

.
 Example: Raw Data Register (Correct Attributable):

Key Columns Explained:

Date – When the test/data was generated.
Analyst Name – Who performed the analysis.
Product Name – Name of the drug or material tested.
Batch No. – Batch identifier for traceability.
Test Performed – Description of the test or analysis.
Instrument ID – Unique ID of the instrument used.
Raw Data Ref. No. – A unique reference to the raw data file, printout, or record (electronic or paper).
Product Reference – Procedure reference
Signature – Analyst's signature to ensure the data is attributable.
 Legible
Documentation should be easy to read and permanent.
• Handwritten entries, signatures/initials and dates on records should be clear
enough to identify the individual who signed the record and should be legible to
reviewers of the documents.
• The documentation should be clear to limit misinterpretation of what was
performed and recorded.
Example :
When making any corrections to raw data, do not obscure the original entry. For
handwritten data, place a single line through the previous entry, and ensure
each correction is properly attributed, including, an initial, date and a clear
reason for the change.
 Contemporaneous

Sign and date records with the date and/or time the data is collected/entered.
• Data entries, initials/signatures, dates, and/or times into
documentation/records are made as the task is performed or observed.
• Late entries should be fully justified and supported by other documents.
• Data entries are not back-dated, post-dated, or pre- completed.
Data must be recorded at the time the work is performed, not before or after.
 Examples of Contemporaneous Practices:

Activity Correct Practice

Write immediately after weighing
Recording weights during dispensing
each material
Record each value as it is read from
Entering pH values during testing
the instrument
Enter at the time of measurement—
Documenting temperature checks
not at the end of shift
Initiate report immediately after the
Deviation reporting
event is discovered
 Original
• The documentation that captures the first-time data are recorded is the
original raw data.
• If procedures require transcription of the data to a paper record or data entry
into a computer, reference the original raw data to confirm its accurate via
signature/initials and date. If possible, keep the original raw data as part of
the raw data package.
• Original study documentation should be appropriately maintained.
 Correct (Original) Example – Lab Balance Printout
Scenario: A QC analyst weighs an active ingredient on a calibrated balance.

This printout is attached to the test data worksheet or filed in a raw data file.
Why it's correct: The printed slip is the first-generation data directly from the
instrument.
It is unaltered and permanently retained. Used to verify calculations and results in
the test report.

Other Examples of “Original” in Practice

Activity Original Record
HPLC test Printed chromatograms, electronic raw files (audit-trailed)
 Accurate
• Documentation contains reliable data and an exact account of events
conducted in an effort to comply with the protocol.
• Data makes sense.
• No approximation, but the actual values.
• Values recorded from an instrument are recorded as presented by the
instrument, i.e units not converted or rounded prior to being recorded and
compliant with the protocol requirements.
• If an instrument is used to collect the data, is the instrument calibrated and
validated as demonstrated by appropriate documentation?
Examples of Accuracy in GDP:
•Includes equipment ID for traceability.
•Observation confirms instrument suitability.
•No rounding, guessing, or omission of decimals.
ALCOA +
 Complete
• All required information should be included in the document, including all relevant
details of description.
• Unused spaces or data entry lines should be marked with a single line through all
the blank spaces, along with “N/A” written along this line; and initials and date to
ensure that data entries cannot be added to it at a later time.
BLANK FIELDS
When populating a form or record never leave a cell or line blank. In the instance
where data or information is not available, it's best to follow the format below to
ensure that GDP practices are being met. N/A and cross out form entries that are not
relevant, or where information is not available.
For sections with form entries that are in a tabular format, a single line can be
used to mark all spaces and N/A can be written along the line. Remember to
initial and date.
 Consistent
The data should be presented, recorded, dated, or time-stamped in the
chronological sequence.

Consistent Example
Scenario: A laboratory analyst is recording pH measurements of a solution during a stability study.

Time Sample ID pH Value Analyst Instrument ID

09:00 AM STB001 6.85 John D. PHM-102
10:00 AM STB002 6.87 John D. PHM-102
11:00 AM STB003 6.86 John D. PHM-102

Why this is consistent:

•Entries are in chronological order.
•Same format is used for time (HH:MM AM/PM).
•Same analyst and instrument are consistently documented.
 Inconsistent Example

Time Sample ID pH Value Analyst Instrument ID

10:00 AM STB002 6.87 John PHM102
09:00 STB001 6.85 J. Doe pHm-102
11:00 AM STB003 6.86 John D. PHM-102

Issues:
•Time format is not consistent ("10:00 AM" vs "09:00").
•Analyst name is inconsistent ("John", "J. Doe", "John D.").
•Instrument ID is inconsistently spelled ("PHM102", "pHm-102", "PHM-102").
Example # 02

1. Laboratory Notebook Entries

Consistent:
•All data entries are made using blue ink.
•Dates follow the same format: DD-MMM-YYYY (e.g., 03-Jun-2025).
•Each test result is recorded immediately after the test and in chronological order.
•Analyst initials are always recorded the same way

Inconsistent:
•Some dates written as 03-06-2025, others as June 3, 2025.
•Analyst signs as “M.T.” in one place, “MT” in another.
•Some results written in red ink, others in black.
•Entry times not in order: 14:00, then 09:00, then 11:00.
 Enduring
Data should be enduring, retaining its integrity over time. Proper storage, backup,
and archiving are always considered essential.
Enduring – Good Examples

• Stored in a validated, access-controlled database with full audit trails

• Backed up regularly to prevent data loss.
• Retained in the system for the full retention period (e.g., 10 years).
• Paper chromatograms stored in fire-resistant cabinets.
 Available
Data must be available for review, inspection, and validation. Accessibility is
critical for transparency and compliance. Throughout the entire lifetime of the
record, paper documents and digital information must be easily accessible for
inspections or investigations. To make retrieval easier, both paper and electronic
material should have clear indexing and/or proper labelling.
Available – Good Examples
•Test results are stored in a validated LIMS (Laboratory Information Management
System).
•Data is indexed and searchable by sample ID, test date, or analyst.
•Data is backed up and can be retrieved on-demand during audits or investigations.
Sign and date every entry with your full Don’t leave entries unsigned or undated.
name or approved initials.
Ensure each record shows who Don’t use correction fluid, tape, or
performed, reviewed, and approved the markers to obscure errors
activity.
Write clearly and in permanent ink. Don’t backdate or post-date entries.
Enter data immediately as the task is Don’t modify original entries without
performed—not later. justification and proper documentation.
Attach original printouts or raw data to Don’t discard original raw data after
batch records when needed. transcription.
Make corrections properly (single line- Don’t use unofficial notes or “scrap
through, initial, date, and reason if paper” for recording critical data.
needed).
All study documentation possesses all Don’t use someone else's login
attributes of ALCOA credentials.
Reference:
U.S. Food and Drug Administration (FDA)