SUSTAINABILITY REPORT 2013-15

People Overview Self Managed Teams Mechanisation Safety Overview The Parivartan     Journey Progress on     Roadmap Incident Statistics Robust Governance Standardised     Processes Enhanced Awareness Capability Building Safety Infrastructure Safety Audits Quality Overview Top-down    Accountability Quality by Design Quality Culture     Transformation Quality Assurance Quality     Best Practices All Time Audit     Readiness Availability Overview Strategic Sourcing Risk Management Product    Rationalisation Success stories Environment Overview Roadmap Energy Management Emissions Water Waste Case Study KPIs Community Overview Focus Areas Education Livelihoods Healthcare Infrastructure     Initiatives Creating Change     Makers Productivity Overview Productivity Streams Case Study PACE Update Initiatives Engineering Excellence Overview Digitisation Automation Mechanisation Lean Manufacturing Capital Equipment Strategy Predictive Maintenance Continuous Improvement Overview Continuous     Improvement     at Work Best Practices Annexures GRI Index Acronyms Assurance Statement   Summary Report     QUALITY ALL TIME AUDIT READINESS A sharp increase in the frequency of site inspections by international regulatory agencies is being witnessed. Quite often, there are surprise inspections. At Dr. Reddy's we are moving towards 'all time audit readiness' by institutionalising a series of self- checks, implementing excellence drives and adopting global benchmarking tools. Three-tier quality management review process Site Level BU Level Sr. Management (CEO/COO) Level Forensic internal audits (unannounced and floor operations focussed) Baseline assessments by third-party consultants (Lachman) Customer audits Annual product quality reviews Protocol-based study to identify and address potential risks We follow the ICHQ7 guidance document, 21 CFR Part 210 and 211, and other regulations as applicable. The following regulatory inspections were performed in FY14 & 15: Formulation Plants Formulations Hyderabad Plant 1 Romania (NAMMD) Formulations Hyderabad Plant 2 Romania Formulations Vizag SEZ Plant USFDA FTO-SEZ USFDA Bristol Plant USFDA API Plants   API Hyderabad Plant 1 EDQM API Hyderabad Plant 2 USFDA API Hyderabad Plant 3 COFEPRIS, USFDA API Hyderabad Plant 4 MHRA API Nalgonda Plant USFDA, EDQM API Srikakulam Plant USFDA Mirfield Plant MHRA