Standard Operating Procedures (SOPs) are an integral part of Good Manufacturing Practices. Without SOPs its really tough to run such big infrastructures of Pharma Manufacturing Units. SOPs are also required as regulatory requirements & every worker must be aware of the SOPs related to his/her job function.

This course defines the 5 pillars on which SOP creation is based. For every Pharma Manufacturing Personnel this course is a must to go through as SOPs are no more a choice rather it’s a mandate.

In Question & Answer Session, get the answers of following Questions: 1. Which Pharma Manufacturing Unit Department is more SOP Oriented? 2. Can you describe Quality Control Department SOP with an example? 3. What QA documents are prepared when the department is started? 4. If the product is ready but its found that it is not as per specifications then how to find where was the actual issue due to which this happened? 5. Now a days online softwares are used in Trainings, how these trainings can be made more effective in cases where actual demonstation is not happening? 6. Can SOP be changed in between when the half process of manufacturing has been done? 7. Can we have more details on Change Control Activities? 8. If we have to change some procedure on urgent basis, should we wait for the SOP revision as it usually takes some time to revise the SOP? 9. Can SOP be changed in between when the half process of manufacturing has been done? 10. Which tool is used to raise the change control? 11. Can you give example of SOP? 12. Can you give more details on Quality Control Equipments? 13. If we share the documents with regulatory body, do we need to share all of the revision history documents? 14. Is there any SOP for preparation of SOPs? 15. Explain the role of IPQA person? 16. Can we have details on Change Control, Risk Assessment, CAPA, Deviations? 17. Why is it necessary to read SOP everyday? 18. Which department handles the rejected material or wastes? 19. As the number of SOPs are very high, how to harmonize to reduce the number of SOPs? 20. Explain CQA & CPP with example? 21. Can you give some examples of QA Guidelines?

Language: Hinglish (a mix of English+Hindi)