Documentation - The First and Last Exit in GMP
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The document discusses regulatory expectations in the manufacturing process, emphasizing the importance of proper documentation and recording procedures to ensure the quality of produced tablets. It raises critical questions regarding the execution of procedures and the consequences of lapses in operational documentation, such as unrecorded incidents during manufacturing. Ultimately, it highlights the necessity of adherence to standard operating procedures to maintain product integrity and safety.
Documentation - The First and Last Exit in GMP
- 1. Documentation The First & Last Exit in GMP 02 Nov 2019, Karachi Regulatory Expectations
- 4. If someone reads detail procedure to swim Can he swim independently? Opening Question 100% 50% 10% 0% 1
- 5. How much you are sure that someone can manufacture tablets if he follows the written SOP and these tablets will be of desired quality? Opening Question 100% 50% 10% 0% 2
- 10. Procedure Execution Recording Documentation Documentation
- 11. Procedure Execution Recording Documentation Documentation Operations Record that describes how an activity, event or process was actually performed
- 12. Procedure Execution Recording Documentation Documentation
- 13. Procedure Execution Recording Documentation Documentation Operations Record for describing activity, event or process (i.e. recordkeeping)
- 14. Procedure Execution Recording Documentation Documentation
- 16. Question Word “Compacted” was left to be recorded on label of SMZ drums What can be the consequences? 3
- 17. Question A breakdown in tray dryer happened after 25 minutes, it was noticed after 45 minutes while temperature went down. It was manufacturing of antihypertensive drug that was reprocessed without recording the incidence. What may go wrong? 4
- 18. Thank You