Definition :
Imagine a pharmaceutical company as a great orchestra. Each musician (department) plays their notes (tasks), but without sheet music (documentation), chaos would ensue. Good Documentation Practice (GDP) is the sheet music of pharmaceutical quality systems.
GDP is a set of systematic principles and practices required to create, handle, and maintain documentation that is clear, accurate, consistent, and reliable throughout the product lifecycle.
It is not merely about writing; it’s about writing the right thing, at the right time, in the right way—and being able to prove it.
Requirements of GDP:
These align with the famous ALCOA+ principles:
Attributable, Legible, Contemporaneous, Original, Accurate, + Complete, Consistent, Enduring, Available
Types of Documentation in GDP:
Advantages of Good Documentation Practice:
- Regulatory Compliance – Avoids warnings, audits, and rejections.
- Product Traceability – Ensures batch recall, history, and quality assurance.
- Legal Evidence – Valid documentation can protect against liability.
- Process Consistency – Facilitates reproducibility and learning.
- Continuous Improvement – Enables root cause analysis and CAPA.
Disadvantages or Challenges:
Though GDP is essential, its practice has inherent challenges:
- Time-Consuming – Real-time recording can slow operational flow.
- Training-Intensive – Requires continuous staff education.
- Error-Prone – Human errors (e.g., illegibility, omissions) are common.
- Costly – Maintaining documentation systems, especially electronic, is expensive.
- Security Risks – Digital systems risk cyber threats if not well protected.
5 principles of good documentation:
GDP Through a Metaphor :
Think of a GMP-compliant facility as a Library of Truth:
- Books = Batches
- Librarians = QA
- Readers = Auditors/Inspectors
- Shelves = Archive Systems
Every book (record) must be well-written, verified, and indexed, so anyone can walk in years later and understand what was done, by whom, how, and why. GDP is the discipline that turns this metaphorical library into a fortress of reliability.
Best Practices for GDP:
- Write in indelible ink
- Cross out errors with a single line and sign/date
- Do not backdate or postdate
- Use approved abbreviations only
- Archive documents as per retention policy
Good Laboratory Practice (GLP)
FAQ – Frequently Asked Questions:
Is GDP only for pharmaceutical companies?
No. GDP is crucial in biotech, food, medical devices, and cosmetics—anywhere quality and compliance are non-negotiable.
How often should documents be reviewed?
Typically, annually or biennially, or upon process/product changes.
Who is responsible for GDP compliance?
Everyone handling regulated documentation—operators, analysts, QA, QC, and management.
What happens if GDP is violated?
Violations can lead to batch rejection, regulatory action, or even license suspension.
What are Good Documentation Practices (GDP) in pharma?
GDP refers to a set of internationally accepted standards that ensure all documents—electronic or handwritten—are accurate, legible, traceable, and reliable. It maintains the integrity of data throughout its lifecycle, ensuring safety, quality, and compliance.
What are the 5 principles of good documentation?
Known as the “Golden Fingers” of GDP, they are:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
What is good documentation practice in GLP?
Under Good Laboratory Practice, GDP ensures all lab notes, protocols, and raw data are complete, verifiable, and traceable. Every experiment’s story must be recorded with scientific honesty.
What is GDP in pharma?
GDP is the guardian of pharmaceutical data integrity, covering how documents are created, maintained, modified, and archived—from batch records to cleaning logs.
What is the difference between GDocP and GMP?
GDocP (Good Documentation Practice) is a subset of GMP (Good Manufacturing Practice).
What is GMP in pharma?
GMP ensures drugs are consistently produced and controlled according to quality standards. It governs production, quality control, premises, and hygiene
What is the ALCOA+ principle?
The ALCOA+ mnemonic describes data attributes:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
+ adds: Complete, Consistent, Enduring, Available.
What is the 21 CFR for GDP?
GDP practices are primarily governed under 21 CFR Parts 210 & 211, ensuring recordkeeping under current Good Manufacturing Practices (cGMP).
What is 21 CFR 210 and 211 cGMP?
Part 210 = GMP definitions and general provisions.
Part 211 = cGMP requirements for finished pharmaceuticals (like equipment, records, labeling, etc.).
What are the 5S in documentation?
Borrowed from lean systems:
- Sort (remove unnecessary data)
- Set in Order (organize)
- Shine (make legible/clean)
- Standardize (use templates)
- Sustain (maintain over time)
What is the golden rule of documentation?
“If it wasn’t documented, it didn’t happen.”
What is the golden rules of documentation?
Be truthful, timely, traceable, transparent, and thorough.
What are the 10 C’s of professional documentation?
Clear, Complete, Concise, Correct, Courteous, Consistent, Coherent, Credible, Contemporary, Compliant.
What are the four documentation techniques?
- Narrative writing (stepwise records)
- Checklists
- Tabular logs
- Graphical/Visual records (charts, plots)
What are 5 fundamental points of GLP?
- Proper study plans
- Qualified personnel
- Accurate instruments
- Reliable data
- Ethical archiving
What are SOPs used for in GLP?
SOPs (Standard Operating Procedures) ensure consistency and compliance in laboratory studies. They guide personnel in how to perform every task.
What is SOP in pharma?
An SOP is a written instruction document that explains how a particular operation is to be performed—whether in labs, production, QA, or warehousing.
How to measure quality of documentation?
Use the Q-DATA Index:
- Quality (completeness, clarity)
- Deficiency rate (number of errors)
- Audit readiness
- Traceability
- Accessibility
How do I measure quality?
Through internal audits, deviation tracking, and user feedback. KPIs like “Right First Time” (RFT) rates are also common.
What is quality of documentation?
The degree to which documentation is clear, correct, consistent, compliant, and complete, preserving the integrity of information.
What is the value of documentation?
It ensures:
- Regulatory compliance
- Product quality
- Patient safety
- Business continuity
What are the 3 types of documentation?
- Policy documents (e.g., Quality Manual)
- Procedural documents (e.g., SOPs)
- Records & Forms (e.g., batch records, logbooks)
What is documentation styles?
Format standards followed across systems:
- Manual logbooks
- Electronic entries (e.g., LIMS)
- Controlled templates
What is a document example?
A Batch Manufacturing Record (BMR)—tracks the journey of a product from start to finish.
How to improve good documentation practices?
Through:
- Training
- Regular audits
- Document control systems
- Visual reminders/posters
- Leadership by example
What are GMP documents?
Includes:
- Master formulae
- Batch records
- SOPs
- Cleaning records
- Deviation reports
- Change control forms
What does GxP mean?
“Good x Practice” where x = Manufacturing (GMP), Clinical (GCP), Laboratory (GLP), etc. All aimed at product quality and patient safety.
What is validation in pharma?
Documented evidence that a process, system, or equipment consistently performs to its intended specification.
What is documentation in pharma?
It is the written proof of every activity, ensuring that each step is reproducible, reviewable, and regulatory-compliant.
What is the GMP process?
The lifecycle involving:
- Design qualification (DQ)
- Installation (IQ)
- Operational (OQ)
- Performance qualification (PQ)
- Ongoing monitoring & control
Why is good documentation important?
Because without it, there is no trust, no traceability, no truth—and in pharma, that could mean compromised patient lives.