Good Documentation Practices (GDP) provides a systematic procedure of preparing, reviewing approving, issuing, recording, storing, and archiving documents. Its basically outlines standards based on which documents are created and maintained.
Thus, GDP provides guidelines one should follow for recording information in a legible, traceable and reproducible manner. Proper documentation is a tangible proof of regulatory compliance at every step of the production process.
On the other hand, poor documentation can lead to non-conformities and regulatory lapses.
Purpose of GDP:
- Compliance with regulatory requirements
- Ensures reliable and consistent transfer of information
- Proper documentation helps ensure product quality and safety
- Prevents dishonesty and fraud, which is essential for producing quality results
- Provides control of processes and improves performance
- Important information is communicated clearly and accurately
- Ensures everyone involved is on the same page
Principles of Good Documentation Practice (GDP):
- Accurate
Information must be correct, truthful, and free from errors. - Legible
Records should be clear, readable, and understandable throughout their retention period. - Contemporaneous
Data should be recorded at the time the activity is performed. - Original
Records should be the first capture of information or a verified true copy. - Complete
All information, including corrections, deviations, and observations, must be documented. - ย Consistent
Documentation should follow a logical sequence with accurate dates and times. - Enduring
Records must remain intact and retrievable throughout the retention period. - Available
Documentation should be easily accessible for review, audits, and inspections.
Why Do Regulators Focus So Much on Documentation?
Regulatory agencies cannot observe every activity performed inside a facility.
Instead, they rely on documentation to verify that operations were conducted according to GMP requirements. Documentation tells the story of a product’s journey from raw materials to finished goods.
The Golden Rule of Good Documentation Practice (GDP)
If it isn’t documented, it didn’t happen.
