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.
๐๐ฎ๐ซ๐ฉ๐จ๐ฌ๐ ๐จ๐ ๐๐๐:
- 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
๐๐ซ๐ข๐ง๐๐ข๐ฉ๐ฅ๐๐ฌ ๐จ๐ ๐๐จ๐จ๐ ๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง ๐๐ซ๐๐๐ญ๐ข๐๐ (๐๐๐):
- ๐๐๐๐ฎ๐ซ๐๐ญ๐
Information must be correct, truthful, and free from errors. - ๐๐๐ ๐ข๐๐ฅ๐
Records should be clear, readable, and understandable throughout their retention period. - ๐๐จ๐ง๐ญ๐๐ฆ๐ฉ๐จ๐ซ๐๐ง๐๐จ๐ฎ๐ฌ
Data should be recorded at the time the activity is performed. - ๐๐ซ๐ข๐ ๐ข๐ง๐๐ฅ
Records should be the first capture of information or a verified true copy. - ๐๐จ๐ฆ๐ฉ๐ฅ๐๐ญ๐
All information, including corrections, deviations, and observations, must be documented. - ย ๐๐จ๐ง๐ฌ๐ข๐ฌ๐ญ๐๐ง๐ญ
Documentation should follow a logical sequence with accurate dates and times. - ๐๐ง๐๐ฎ๐ซ๐ข๐ง๐
Records must remain intact and retrievable throughout the retention period. - ๐๐ฏ๐๐ข๐ฅ๐๐๐ฅ๐
Documentation should be easily accessible for review, audits, and inspections.
๐๐ก๐ฒ ๐๐จ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฌ ๐
๐จ๐๐ฎ๐ฌ ๐๐จ ๐๐ฎ๐๐ก ๐จ๐ง ๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง?
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.
๐๐ก๐ ๐๐จ๐ฅ๐๐๐ง ๐๐ฎ๐ฅ๐ ๐จ๐ ๐๐จ๐จ๐ ๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง ๐๐ซ๐๐๐ญ๐ข๐๐ (๐๐๐)
๐๐ ๐ข๐ญ ๐ข๐ฌ๐ง’๐ญ ๐๐จ๐๐ฎ๐ฆ๐๐ง๐ญ๐๐, ๐ข๐ญ ๐๐ข๐๐ง’๐ญ ๐ก๐๐ฉ๐ฉ๐๐ง.
