What is documentation and Why it is important in pharmaceutical industry? What is basic requirements of the GDP?

Documentation:

In the pharmaceutical industry, documentation refers to the systematic recording, management, and control of information related to the development, manufacturing, testing, distribution, quality control and quality assurance of pharmaceutical products. Documentation plays a critical role in ensuring compliance with regulatory requirements, maintaining product quality, and supporting decision-making processes within pharmaceutical industries.

Documentation in the pharmaceutical industry includes various types of documents such as: BMR, BPR, SOP's, Validation documents, Training Records, Quality Control Records, Change Control Documentation and Regulatory Submission Documents etc.

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 Good documentation practices: 

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.