Astrazeneca P Date of Issue: 15° Sep 2016 | Review date 10" Sept 18 Version: 3 Supersedes: V2 AZPIL Marketing Company Quality Manual Prepared by: De oka CG, Manze Regulatory Afi and Paint Say Dat: vals 2cie Authorized By: De. BM Nagaraju: Head Regulatory Affairs and Patient Safety Date: \s\\ 06 ¢ sre feds _ gun Mr. Sanjay Murdéstwar: Country President & Managing Director Date:astrazenece? Purpose AstraZeneca India Pharma India Lid (AZPIL) is committed to the development, ‘manufacture and supply of high quality of medicines in compliance with Company standards, Intemational codes, standards and regulations and local regulatory requirements. ‘The AstraZeneca Code of Conduct, Global Policies and Intemational Procedures describe the expectations and processes with which all AstraZeneca employees must comply in order to meet the high ethical standards expected of everyone. The Global Policy on Quality and Regulatory Compliance sets out the minimum standards for Quality and Compliance across the product development, manufscture and distribution value chai, including relevant marketing company activities. ‘The purpose of this document is to describe the key aspects of the Quality ‘Management system to be established in the AstraZeneca India Pharma India Ltd ‘marketing companies, Scope ‘This standard specifies the QMS for AZ MCS in relation to: + Good Clinical Prative (GCP) for Nor interventional studies involving primary data collection ‘Good Pharmacovigilance Practice (GVP) Good Regulatory Practice (GRP) ‘Good Manuftcturing Practice (GMP) Good Distibution Practice (GDP) Procedure 1.Quality Policy AZPIL is committed to the detivery of high quality services and solutions to our customers and stakeholders, This is achieved through our commitment to quality, our patient and customer foeus and the dedication of all employees, The Marketing Company President of AZPIL is accountable for and committed tothe development of a cultue of Quality Assurance and for compliance with appropriate extemal and internal codes of practice in the GxP regolated envionment and shall appoint a Gx? Coordinator. General requirements: ‘The Country President mst ensure that there is an appropriate GxP quality system in place to cover the relevant activitesAstrazeneca? “The quality system must provide the following ass minimum: ‘+ The appointment of person who ensures that relevant GxP procedures are in place. ‘© The person responsible within the MC must make sue that all GXP activities, they faze not adequately desribed in global Standard Operating Procedures (SOPs), are “imescales s a 2 oo eae 3 maser ont 3 tacos osu, Revie plans for GXP 3 aeares ‘ie a esis : ereAstrazeneca? GaP Ouality Incidents: GRP Area | Description of | Date lentiied | Status ‘Comments ‘the Event ‘oP MP ‘avr ocr oR GaP Iesues and Risks/Outwoursed Activities: Key Issues and Risks GRP Awa [Dessipion of | Rey Action | Status Comments ‘the IssveRisk oP OMe ‘GP Gor “GRPAstrazeneca? ‘Out Sourced activites ‘GXP Area ‘Descripiion of | GxP Activity | Status ‘Comments | outsourced activity ‘ap? ‘OM ar or ORF ‘Assessments, Audits, KPI and CIP: ‘Assessments and Awaits - ‘GXP Area [Type of aie] Status | Summary of Findings and Actions Assesament Audit cor MP ~ avr ocr a ‘Overall Siaius of Country Quality KPIs and Compliance lmprovement Plans ‘Overall Status of Country Quality KPIs and Compliance Improvement Plans ‘Numberof [Number [Number on | Curent | Overall Kpis/Actvities | completed |Track [sues | status Country quality KPIs ‘Compliance Improvement plans