GMP Regulatory Perspective Dr Pooja Mahadev Shirodkar Wallace

GMP Regulatory Perspective Dr. Pooja Mahadev Shirodkar Wallace Pharmaceuticals Pvt. Ltd. Date: 16. 03. 2016

• 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.

Inspection process (Quality system Inspection technique)

Numbers of 483 s issued from 2006 to 2015 800 746 758 787 690 649 645 594 572 600 678 498 500 400 300 200 100 0 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015

Top 15 FDA’s 483’s Items of 2015 4. 10% 4. 70% 4. 50% 6. 00% 11. 10% 50. 80% 18. 70% SOP's Quality control Investigation Faliure Housekeeping Facility Process control Records

Now What ?

Steps for change Identification Evaluation Investigation Action Plan Implementation Effectiveness

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

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

Investigation

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.

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

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

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

• Thank You