1. GMP Regulatory Perspective Dr. Pooja Mahadev Shirodkar Wallace Pharmaceuticals Pvt. Ltd. Date:16.03.2016

2. In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug.

4. Inspection process (Quality system Inspection technique)

5. Numbers of 483s issued from 2006 to 2015

6. Top 15 FDA’s 483’s Items of 2015

7. Now What ?

8. Steps for change Identification Evaluation Investigation Action Plan Implementation Effectiveness

9. Identification QMS has systems to detect NC -Customer Complain -Equipment Monitoring -Production -Auditing -Inspection -Trending -Accident Report

10. Evaluation Data /trends Data/ Records Expert Interview Responsible persons/Timeline Evaluation may be defined by QMS (severity, probability of harm, Cost) Documentation

11. Investigation

12. Action Plan Corrective and Preventive action.(CAPA) CAPA is the heart of quality management system. Corrective action should be planned and executed in a way that it totally eliminate the possibility of reoccurrence of an issue.

13. Implementation Identification of task owners and task due dates. Validation/Verification of Method. Risk assessment Documentation

14. Effectiveness Monitor performance -compare before and after Achieve specific targets Statistical data analysis—Performance must lie within a set of statistically derived control limits Documentation

15. References www.cdsco.nic.in www.fda.gov www.ich.org/fileadmin https://www.gov.uk/government

16. Thank You