Good Documentation Practices are essential for maintaining accurate, reliable, traceable, and compliant pharmaceutical records. This practical guide explains Good Documentation Practices in pharmaceutical manufacturing, including data recording, corrections, date and time formats, document control, master and controlled copies, signatures, blank fields, instrument printouts, rounding of results, document retention, and common documentation errors.
Introduction to Good Documentation Practices
Documentation is one of the most important elements of a pharmaceutical quality system. Every significant activity related to manufacturing, testing, storage, engineering, validation, calibration, quality assurance, and other GMP operations should be supported by reliable and traceable records.
Good Documentation Practices (GDP) provide a structured approach for creating, recording, reviewing, correcting, approving, controlling, storing, and retaining GMP documents and records.
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What Are Good Documentation Practices?
Good Documentation Practices are the established practices used to ensure that GMP-related information is:
- Accurate
- Complete
- Legible
- Traceable
- Consistent
- Available when required
- Recorded at the appropriate time
- Protected against unauthorized alteration
- Retained for the required period
GDP applies throughout the document lifecycle, beginning with document preparation and continuing through review, approval, issuance, use, archival, and eventual disposal.
Documentation can exist in different forms, including paper records, electronic records, instrument printouts, photographs, laboratory records, logbooks, protocols, reports, and computerized-system records. EU GMP documentation principles cover both instructions and records used to demonstrate GMP activities.
Why Are Good Documentation Practices Required?
The basic principle behind GDP is simple:
If an activity is not properly documented, it becomes difficult to demonstrate that the activity was actually performed correctly.
Good documentation helps organizations:
- Demonstrate GMP compliance.
- Maintain product and process traceability.
- Support batch release decisions.
- Provide evidence during regulatory inspections.
- Protect the integrity of laboratory and manufacturing data.
- Identify errors and investigate deviations.
- Establish accountability for performed activities.
- Support investigations, CAPA, change control, and risk assessments.
- Prevent unauthorized or unexplained changes to records.
- Maintain historical information for future reference.
Importance of GDP in Pharmaceutical Manufacturing
GDP affects almost every department in a pharmaceutical organization.
| Department | Examples of GDP Applications |
|---|---|
| QA | SOPs, deviations, CAPA, change control, audits |
| QC | Analytical worksheets, laboratory notebooks, test results |
| Production | BMR/BPR, equipment logs, process records |
| Engineering | Calibration, maintenance and qualification records |
| Warehouse | Material receipt, dispensing and storage records |
| Microbiology | Environmental monitoring and microbiological records |
| Validation | Protocols, reports and qualification records |
| HR/Training | Training records and specimen signatures |
Regulatory and GMP Expectations for Good Documentation Practices
GDP requirements should always be implemented according to the applicable regulations, regulatory commitments, approved procedures, and the organization’s pharmaceutical quality system.
EU GMP Chapter 4 emphasizes document control, accuracy, integrity, availability, legibility, appropriate documentation, and retention.
FDA’s data integrity guidance states that data used for CGMP purposes should be reliable and accurate and recommends appropriate controls for preventing and detecting data integrity problems.
WHO’s current data integrity guidance also includes specific considerations for good documentation practices, data governance, computerized systems, data review, and approval.
ALCOA and ALCOA+ principles in Good Documentation Practices
A practical way of understanding GDP is through the ALCOA principles:
- Attributable – It should be possible to identify who performed or recorded the activity.
- Legible – Records should be readable and understandable.
- Contemporaneous – Information should be recorded when the activity is performed.
- Original – The original record or an appropriately controlled true copy should be maintained.
- Accurate – Recorded information should correctly represent what occurred.
The commonly used ALCOA+ concept additionally emphasizes that records should be:
- Complete
- Consistent
- Enduring
- Available
Detailed Good Documentation Practices
1. Record Information at the Time of Activity
Entries should be made contemporaneously, meaning information should be recorded when the activity is performed.
For example, if a temperature reading is taken at 10:15, the record should reflect the actual observation at that time rather than being reconstructed later from memory.
2. Use Permanent and Approved Writing Instruments
Official GMP records should be completed using the writing instrument specified in the applicable site procedure.
The instrument should produce a permanent and readable entry.
Pencil & Gel pen should not be used for permanent GMP records because entries can be erased or altered.
3. Never Overwrite an Original Entry
Overwriting is not an acceptable method of correcting GMP records.
For example, changing:
5611 → 5811
by writing over the original number makes it difficult to determine what was originally recorded.
The original information should remain visible.
4. Correct Errors Without Hiding the Original Entry
When a handwritten error is identified, the correction should preserve the original information.
A generally acceptable approach is:
Incorrect: 5611
Corrected: 5611 5811
The correction should:
- Leave the original entry readable.
- Be made using the approved writing instrument.
- Include the initials/signature of the person making the correction.
- Include the date where required.
- Include a reason for correction when required by the site’s procedure.
- Never obscure or destroy the original information.
5. Record the Reason for a Correction When Required
Where the pharmaceutical site’s procedure requires a reason for correction, an appropriate reason should be documented.
Examples may include:
| Code | Meaning |
|---|---|
| TY | Typographical error |
| TE | Transfer error |
| CE | Calculation error |
| WE | Writing error |
| SUP | Supplementation |
These abbreviations should only be used if they are defined and approved within the organization’s documentation procedure.
6. Do Not Use Ditto Marks
Repeated information should be entered again where the form or procedure requires an individual entry.
Avoid using:
- Ditto marks
- Repeated quotation marks
- “Same as above”
- “—do—”
7. Record Actual Instrument or Displayed Values
When recording information from an instrument, PLC, balance, computer display, or other digital display, the value should be transcribed accurately according to the applicable procedure.
For example, if a balance displays:
1.0009 g
the recorded value should not be changed arbitrarily to:
1.001 g
8. Date and Time Recording
The organization should establish a consistent date and time format through its approved documentation procedure.
If the site procedure specifies the DD/MM/YYYY format, an example would be:
01/01/2026
Time may be recorded using the 24-hour format when specified by the procedure.
For example:
- 9:00 AM → 09:00
- 9:00 PM → 21:00
9. Do Not Leave Required Fields Blank
Personnel should complete all applicable fields in a document.
If a field genuinely does not apply, an approved designation such as NA or N/A may be used according to the site’s procedure.
However, NA should not be used to avoid making a required entry.
For a section or step that is genuinely not applicable, the site procedure may require the area to be clearly marked, for example:
NA + signature/initials + date
Signatures and Specimen Signatures
Signatures are an important part of GMP traceability.
Personnel should use only their authorized signature or initials as defined by the organization’s approved specimen signature system.
A signature should allow the organization to identify the person who performed, reviewed, verified, or approved an activity.
Personnel should not:
- Sign on behalf of another person.
- Pre-sign blank forms.
- Share signatures.
- Use another person’s credentials.
- Backdate records.
- Sign activities that they did not perform or review.
Where required, signatures should be accompanied by the date and, where applicable, time.
Good Documentation Practices for Calculations
Calculations recorded in GMP documents should be clear, traceable, and independently verifiable where required.
A reviewer should be able to understand:
- The values used.
- The calculation performed.
- The result obtained.
- Any applicable conversion factor.
- Any rounding applied.
For example:
Weight A = 125.4 mg
Weight B = 124.8 mg
If an average is required:
Average = (125.4 + 124.8) / 2 = 125.1 mg
Practical GDP Checklist
Before completing or reviewing a GMP record, ask:
| Checkpoint | Question |
|---|---|
| Attribution | Can the person who performed the activity be identified? |
| Legibility | Can the entry be clearly read? |
| Timing | Was the information recorded at the time of activity? |
| Originality | Is the original record or controlled true copy available? |
| Accuracy | Does the entry represent the actual observation? |
| Completeness | Are all required fields completed? |
| Corrections | Are corrections traceable and justified? |
| Date | Is the approved date format used? |
| Time | Is the required time format used? |
| Signature | Is the authorized signature/initial used? |
| Review | Has the record been appropriately reviewed? |
| Traceability | Can the record be linked to the relevant activity, batch, equipment, or sample? |
Common Good Documentation Practices Mistakes
Some common documentation problems include:
1. Backdating entries
Entering information later while making it appear as though it was recorded earlier compromises contemporaneous recording.
2. Overwriting numbers
Changing an existing number by writing over it makes the original information unclear.
3. Using correction fluid
Correction fluid hides the original entry and prevents proper traceability.
4. Leaving unexplained blank spaces
Blank fields can create uncertainty about whether an activity was performed.
5. Pre-signing records
Signing a document before an activity has actually been performed is unacceptable.
6. Using another person’s signature
Every person should use only their authorized signature or credentials.
7. Recording rounded values unnecessarily
Original instrument readings should not be unnecessarily rounded or truncated.
GDP and Data Integrity
GDP and data integrity are closely connected but are not exactly the same concept.
GDP focuses strongly on how information is created, recorded, corrected, reviewed, controlled, and retained.
Data integrity is broader and concerns the reliability, completeness, consistency, and trustworthiness of data throughout its lifecycle.
A strong documentation system therefore supports the wider pharmaceutical data-integrity program.
FAQs – Good Documentation Practices
What are Good Documentation Practices in pharmaceuticals?
Good Documentation Practices are procedures and practices used to ensure that pharmaceutical documents and records are accurate, complete, legible, traceable, contemporaneous, controlled, and available throughout their required lifecycle.
What does ALCOA mean in GDP?
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. These principles are commonly used to describe fundamental expectations for trustworthy GMP data.
Can correction fluid be used in GMP documents?
No. Correction fluid, tape, erasers, or similar methods that hide the original entry should not be used for GMP records.
How should an incorrect handwritten entry be corrected?
The incorrect entry should generally be crossed out with a single line so that it remains readable. The correct information should be entered, with the required signature/initials, date, and reason for correction where applicable.
Can a GMP record be completed later?
GMP records should normally be completed contemporaneously, meaning at the time the activity is performed. If a delayed entry is genuinely necessary, it should be handled according to the site’s approved procedure and remain transparent and traceable.
Can NA be written in a blank field?
NA or N/A may be used when a field genuinely does not apply and the site’s procedure permits it. It should not be used to avoid completing a required GMP entry.
Why should overwriting be avoided?
Overwriting can hide the original information and prevent reviewers from determining what was initially recorded. This creates a data-integrity concern.