1. Good Manufacturing Practices – A Regulatory Perspective Presented By: Ashok Kumar Dua Plant Head – Unichem Laboratories (Sikkim )

2. GMP – Good Manufacturing Practices. Till yesterday everything was fine !! But suddenly there is a problem in understanding of GMP in Indian Pharmaceutical Industry. Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

3. What has gone wrong ? Are we not able to understand the concept of GMP now ? Something is really serious ? Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

4. Why it is happening ? The main reason is changed scenario of the industry Increased expectation from the Regulatory bodies Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

5. Why it is happening ? Increased regulatory oversight in the past year or two has forced quality, regulatory, and compliance personnel to be on their toes. One way that's a good thing in terms of ensuring Quality and, ultimately, protecting patients and end-users. However, it's not without its headaches - particularly when facing an increasingly demanding & inconsistent inspection environment. Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

6. What we need to do now ? The key to inspection preparedness, however, is to cultivate a culture of quality within an organization rather than a culture of compliance We need to understand that a culture of quality is characterized by the mindset, "this is how our organization operates on a day-to-day basis under the confines of our quality management system," rather than approaching every day as if, "we're just trying to get ready for the next inspection." Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

7. What we need to do now ? Beyond building a culture of quality, industry can more nimbly navigate the somewhat-volatile inspection process by being aware of patterns and trends that have emerged in recent months as part of increased oversight Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

8. What are the emerging Trends ? Variation in investigator experience Heightened scrutiny of purchasing controls Elevated expectation of thoroughness and supporting documentation Increased emphasis on timeliness of responses and investigations Emerging focus on product in commercial distribution Mounting emphasis on management awareness Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

9. What is the Trend in GMP C ompliance ? Increasing Number of Inspections Increasing numbers of Warning Letters Increasing Enforcement Penalties Increasing Harmonization between Regulatory Agencies Increasing use of Science & Technology Increasing use of subject matter expert Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

10. What is the Top issue for C ompliance ? The top issue in the Warning Letters is the non- GMP compliant handling of electronic data or missing data integrity 8 warning letters contains the following comment in the same wording : Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

11. What is the Top issue for C ompliance ? The top issue in the Warning Letters is the non- GMP compliant handling of electronic data or missing data integrity 8 warning letters contains the following comment in the same wording : Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

12. What is the Top issue for C ompliance ? "Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data." "Failure of your quality unit to ensure that materials are appropriately tested and the results are reported.“ "Failure to adequately investigate complaints and extend the investigations to other batches that may have been affected." "Failure to have appropriate controls for issuance of batch records" "Failure to have appropriate documentation and record controls.” "Failure to record activities at the time they are performed and destruction of original records.”

13. What is the Top issue for C ompliance ? This selection of examples shows the lack of fundamental GMP principles which leads to a blatant misconduct of staff and ultimately to quality defects in the final product. The main responsibility usually has the quality unit, which task it actually would be to ensure a thorough training in production and quality control and to monitor compliance with the appropriate regulations. Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

14. What is the Top issue for C ompliance ? These examples of non-GMP-compliant behavior are not limited to active ingredient manufacturers; there are very similar findings in Warning Letters issued to medicinal product manufacturers. Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

15. How do you feel about these trends and the impact on your work and your organization ? What will you do differently in your work as a result of knowing this trend ? Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

16. What can be achieved by using trends ? Knowledge of GMP Trends can be used for developing, leading, managing and building GMP compliant work ethics and organizational culture for Quality. Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

17. What can be achieved by using trends ? Knowledge of GMP compliance trends can be useful in pharmaceutical sectors to guide daily work, lead and manage operational control and to develop and execute strategic planning. Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

18. What is your Perspective ? What is your opinion on 3-5 leading trends in GMP Compliance for Pharmaceuticals What is the value to you in knowing the regulatory compliance trends ? How can a small to medium scale company best use knowledge of the current trends ? Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

19. What is the Global Perspective ? “ To learn and become better prepared for future inspections”. “ To hopefully prevent serious problems later on that would put us, or our customers at risk including the regulatory agencies that regulate us.” What are we doing to prevent this citation from being ours Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

20. What is the Global Perspective ? “ To learn and become better prepared for future inspections”. “ Put companies on alert to strengthen their SOPs – the way they are written and the way they are used to train personnel”. Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )

21. THANKS FOR LISTENING !! Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )