Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
Importance of documentation:
As per GMP "If it is not written down, then it did not happen". Document provides information on when, where, who, why and how to complete the task. Document provides evidence proving that the tasks have been completed as they should be.
GDP in Pharmaceuticals
Basic requirements of GDP:
1. Always record the entries at the time of activity simultaneously.
2. Always record date with signature in GMP records.
3. Always use indelible ballpoint pen to record data in GMP records.
4. Always enter the data directly in the GMP records in English language.
5. Never use pencil or erasable or water-soluble ink pen to complete the GMP records.
6. Never use white ink or correction fluid to correct the entry in GMP records
7. Never sign for someone else on any document. Only sign for the work that you have performed yourself.
8. Never back date GMP records.
9. Never discard original raw data of any kind.
10. Never use scratch papers, loose papers or “post it” to record the data.
11. Never discard or destroy any GMP record unless retention period expiry is reached.
12. Documentation and records used throughout the manufacturing process, as well as supporting processes must meet the basic requirement of GDP.
Tags:
Production