Seminario SSFA. New Guideline on Good Pharmacovigilance Practice (GVP) Fare clic per modificare lo stile del sottotitolo dello schema

Size: px
Start display at page:

Download "Seminario SSFA. New Guideline on Good Pharmacovigilance Practice (GVP) Fare clic per modificare lo stile del sottotitolo dello schema"

Transcription

1 Seminario SSFA New Guideline on Good Pharmacovigilance Practice (GVP) Pharmacovigilance Systems and their Quality Systems Milano, 20th April 2012 GIULIA M. VALSECCHI The proposed GVP - Module 1 Guidance on establishment and maintenance of a Quality Assured Pharmacovigilance System Released for consultation: 21 February 2012 End of consultation: 18 April 2012 Final version effective from July

2 The proposed GVP - Module 1 Legal basis REG 1235/ Article 87 (b) the minimum requirements for the quality system for the performance of pharmacovigilance activities by the Agency DIR 2010/84 - Art. 108 (b) the minimum requirements for the quality system for the performance of pharmacovigilance activities by the national competent authorities and 3 The proposed GVP - Module 1 Table of Contents: I.A. Introduction I.B. Structure and Processes I.C. Operation of EU network Principles of the GVP Module 1 consistent with general principles of ISO 9000 Reference to REG., DIR., IM (Implementation Measures) Fare clic per modificare lo stile del sottotitolo Shall vs Should dello schema 4

3 What is QUALITY? The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. [Source: ISO 8402:1994 Quality management and quality assurance Vocabulary, withdrawn and revised by ISO 9000:2000 Quality management systems -- Fundamentals and vocabulary, March ] 5 Quality NOT a qualitative BUT a quantitative concept MEASURED: AGAINST PREDEFINED QUALITY REQUIREMENTS DOCUMENTED : NOT WRITTEN NOT EXISTING 6

4 Quality Dimensions EXPECTED By the client or from the supplier, in order to satisfy its requirements DESIGNED Set of quality attributes of SERVICE/product together with processes and resource organization prepared in order to achieve quality PROVIDED Set of quality attributes of SERVICE/product obtained at the end of a process PERCEIVED What is evaluated by the client in terms of requirement/need satisfaction 7 The Quality Route From QUALITY CONTROL (oriented to products) through QUALITY ASSURANCE (oriented to processes) to QUALITY MANAGEMENT (oriented to systems) 8

5 Quality System Requirements Used Known Documented 9 Continuous Improvement The Quality System is never complete! Objective oriented and systematic development Satisfied Customer/End User as ultimate goal Continuous improvement Reviews for follow-up 10

6 Reference for Pharmacovigilance Quality System Predicate Rules Systems to ensure pharmaceutical quality, defined as established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness Quality System (i.e. ISO 9000 series) Requirements needed to ensure organizations meet the needs of its customers while striving to meet their expectations, more generic, fits all companies 11 New PhV standards: Changing Perspective Written Procedures Training Audit Document management (record retention) Quality objectives and requirements Structure and process Measurement Improvement FROM QUALITY ASSURANCE TO QUALITY SYSTEM 12

7 Pharmacovigilance: the complex environment Technical Operation Clinical Operation Regulatory Medical Informatio n Legal Investigators CRO Drug Safety Unit Affiliates Ethical Committe e Regulatory Authorities Licensing Partner Quality Assurance Informatio n Technolog y 13 Quality System for Pharmacovigilance The Quality System should be seen as an integral part of the Pharmacovigilance System The following areas are considered in defining the minimum requirements: Resource Management (I.B.5; I.B.6, I.B.7, I.B.8) Compliance Management (I.B.9, I.B.11.3, I.B.12) Record Management (I.B.10, I.B.11) 14

8 Quality System for Pharmacovigilance Systematic Approach Definition of quality objectives General Structure and process specific Definition of method for monitoring Identification of indicators 15 I.B.1 Pharmacovigilance System A Pharmacovigilance System is defined as a system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance [DIR Art 1(28d)]. A Pharmacovigilance System, like any system, is characterised by its structures, processes and outcomes. 16

9 I.B.2 Quality of Pharmacoviglance system Quality of Pharmacovigilance System can be define as all the characteristics of the system which are considered to produce outcomes relevant to the objectives of PhV. 17 I.B.2 Quality Requirements and Quality Objectives Quality Requirements are those characteristics that are likely to produce the desired outcome (Quality Objective) Overall quality objectives of PhV [I.B.4]: Complying with legal requirements Preventing harm from AE in humans Promoting safe and effective use Contributing to the protection of patients Specific quality objectives in each Module of GVP 18

10 I.B.3 Quality Cycle Establishing structures and planning integrated and consistent processes (quality planning) Carrying out the tasks and responsibilities (quality control) Monitoring and Evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out (quality assurance); and Correcting and improving the structures and processes and the carrying out of those processes Fare clic per as necessary modificare (quality lo stile del improvements) sottotitolo dello schema 19 Model of a process-based quality management system 20

11 I.B.5. Principles for good Pharmacovigilance practices The needs of the stakeholders in relation to the safety of medicine are met Leadership is provided by High Management All people are involved according to task and responsibilities and engaged in continuous improvement Resources and activities are defined as structure and processes Risk-benefit balance is continuously assessed Good cooperation between MAH, CA, Patients, HCP, licensing partner is fostered (-> communications) 21 I.B.6. Responsibilities 1/2 What is High Management responsible for? Motivating all staff members, Assigning roles, responsibilities and authorities to staff members according to their competencies and communicating and implementing these throughout the organisation. 22

12 I.B.6. Responsibilities 2/2 What is Management responsible for? Quality system is documented Change are controlled Adequate resources are available and training is provided Suitable and sufficient premises, facilities and equipment are available Effective communication flows are set and applied Any concern is properly investigated Fare clic per modificare Audit lo stile are del performed sottotitolo dello schema Quality system is reviewed at regular intervals to verify its effectiveness and CAPA measures are defined and introduced 23 I.B.7 Training Essential for achieving the required quality Plan, Execute, Check Training record management Initial and Maintenance training Different level according to different responsibilities 24

13 I.B.8 Facilities and equipment Essential for achieving the required quality Properly located, designed, manufactured, and maintained Subject to appropriate checks, qualification and/or validation activities Risk assessment 25 I.B.9.1 Specific Quality System Processes Pharmacovigilance data are continuously monitored, option for risk minimization and prevention are considered and appropriate measure taken All information on the risk of medicinal products is evaluated scientifically Data on serious and non-serious adverse reactions are submitted to the EV database Data are verified and duplicate are detected Communication with CAs is effective Product information is kept up-to-date with the current scientific knowledge Appropriate safety communications with HCP and patients 26

14 I.B.10 Record Management Ensures data/documents maintenance, retrieval and traceability Covers: Completeness, accuracy and integrity of PhV data Internal and external communication Document retention Measure Fare clic shall per be modificare taken at lo each stile del stage sottotitolo in the dello storage schema and processing of PhV data to ensure data security and confidentiality (limited access to authorised personnel) Personal data protection has to be fully and effectively guaranteed in conformity with legal provisions Protection from destruction, expecially during the retention period 27 I.B.11 Documentation of the Quality System All elements, requirements and provisions adopted for the quality system shall be documented in a systematic and orderly manner in the form of written policy and procedures, such as quality plans, quality manuals and quality records. Quality Plan sets the quality objectives and the processes to achieve them Procedures are the way to carry out a process, may take the format of a SOP, Work Instruction or manuals Quality Manual defines the scope of the quality system and the processes Quality Records provides evidence of activities performed 28

15 Quality Manual Table of Contents 29 Traceability between ISO requirements and PhV processes ISO Requirements PhV Processes 4 - QUALITY MANAGEMEN SYSTEM Documentation Management Record Management 5 - MANAGEMENT RESPONSIBILITIES Management Review 6 - RESOURCES MANAGEMENT 7 SERVICE REALIZATION 8 MEASUREMENT Training Facilities, Equipment Safety monitoring Risk Management Case Management Periodic Report Complaint Literature Search Product Information management Internal Audit Deviation Management CAPA 30

16 I.B.11 Documentation of the Quality System Includes Organizational structure documents (organisation diagram, job descriptions) Training plan and records (to be available for audit and ispection) Instructions for compliance management process and critical processes (SOPs, WI) Performance indicators Audit reports Methods for monitoring the system effectiveness Records created as a results of Pharmacovigilance activities Records and report relating to facilities and equipment Records to demonstrate deviation management/capa/effectiveness checks Record management 31 Structure of the PhV QMS documentation Quality Management Manual (QMM) Process 1 Process 2 Process 3 Process X SOP 1 SOP 2 WI 1 Record Record 32

17 Structure of the PhV QMS documentation QMM Process Procedures Work Instructions Forms & Records 33 I.B.11.3 Critical Pharmacovigilance processes Continuous safety profile monitoring Risk management system ICSR processing Signal detection and evaluation Periodic reports management (scheduling, preparation including QC-, assessment and submission) Managing request and communication with CAs Interaction between Pharmacovigilance and quality defects system Appropriate instructions should be available for critical PhV processes Communication about safety Keeping product information up-to-date Implementation of variations 34

18 I.B.12. Monitoring performance and effectiveness Reviews of the systems by management (Management Review) Risk based audits at regular interval Quality system documentation reviewed at regular interval Review program Compliance Monitoring Evaluating Fare clic the per modificare effectiveness lo stile of del actions sottotitolo taken dello with schema medicinal product for the purpose of minimising risk and supporting the safe use CAPA system in place The organisation should define in advance the method for monitoring and the indicators to be used to demonstrate the effectiveness in operating the Pharmacovigilance system 35 I.C. Operation in the EU network I.C.1 Overall Pharmacovigilance responsibilities of the applicant and the MAH in the EU I.C.2. Overall Pharmacovigilance responsibilities within the EU regulatory network The MAH shall operate a Pharmacovigilance system and shall establish and follow a quality system In some circumstances, it should be possible to establish more than one Pharmacovigilance system (i.e. in case of specific products such as vaccines or product available without medical prescriptions) 36

19 I.C.1.1. Responsibilities of the MAH in relation to QPPV The MAH shall have permanently and continuously at its disposal an appropriately qualified person responsible for Pharmacovigilance in the EU (QPPV) Job description of QPPV In addition a local contact person acting at national level and reporting to QPPV The QPPV shall have the necessary level of authority 37 I.C.1.1. Responsibilities of the MAH in relation to QPPV The MAH should ensure that the QPPV receives/can access all the relevant information, in particular: Emerging safety concerns and other information related to benefitrisk evaluation of a medicinal products covered by the Pharmacovigilance system On going or completed clinical trials Compliance information Outcome of regular reviews of quality system 38

20 I.C.1.2. Qualification of QPPV in the EU Theoretical and practical knowledge for the performance of Pharmacovigilance activities Expertise or access to expertise in relevant areas Qualification of QPPV shall be assessed prior appointment QPPV should be provided with training on MAH s Pharmacovigilance system(s) before taking up the position 39 I.C.1.3. Role of the QPPV The QPPV is a natural person Shall reside and operate in the EU Accessible through QPPV s contact details A Back up person shall be ensured Responsible to establish and maintain the MAH s Pharmacovigilance system Authority and responsibility over the Pharmacovigilance System Master File The QPPV may delegate specific tasks, under supervision, to appropriately qualified and trained individuals, for example, acting as safety experts for certain products, provided that the QPPV maintains system oversight and overview of the safety profiles of all products. Such delegation should be documented 40

21 I.C.1.3. Role of the QPPV Oversight over the functioning of the system in all relevant aspects, including its quality system: SOPs Contractual Agreements Database operations Compliance data regarding quality, timeliness of expedited and periodic reporting Audit reports Training of personnel in relation to Pharmacovigilance Should be aware about the validation status of the database and informed about significant changes 41 I.C.1.4. Specific Quality System processes of MAH in EU Submission of adverse reaction data to EV within the legal timelines Monitoring the use of terminology, with data entry staff being instructed in the use of terminology Retention of essential documents describing the Pharmacovigilance system as long as the system described in the Pharmacovigilance System Master File exists and for at least further 5 years after it has ceased to exist Retention of Pharmacovigilance data and documents relating to authorised medicinal products as long as the MA exists and for at least further 10 years after the MA has ceased to exist Product information is kept up-to-date with current scientific knowledge, including the assessments and recommendations made public via the European medicines 42

22 I.C.1.4. Specific Quality System processes of MAH in EU RECORD RETENTION The retention periods apply unless longer periods are required by applicable regulatory requirements or national law During the retention period, retrievability of the documents should be ensured Documents can be retained in electronic format, provided that the electronic system has been appropriately validated and appropriate arrangements exist for system security, access and back-up of data. If documents in paper format are transferred into an electronic format, the transfer process should ensure that all of the information present in the original format is retained in a legible manner and that the media used for storage will remain readable over time. 43 I.C.1.5. Quality System Requirements for PhV task delegated by MAH The MAH may transfer any or all of the Pharmacovigilance tasks, including the role of the QPPV, to another organisation or person (where the same requirements apply to a person as for an organisation). The ultimate responsibility for the fulfilment of all Pharmacovigilance tasks and responsibilities and the quality and integrity of the Pharmacovigilance system, however, always remains with the MAH All guidance provided in GVP is also applicable to the other organisation to which the tasks have been delegated Detailed, up-to-date and clearly documented contractual arrangements between the MAHand the other organisation are in place, describing arrangements for delegation and the responsibilities of each party. 44

23 I.C.2. Overall Pharmacovigilance responsibilities within the EU regulatory network Role of Competent Autorities in Member States Role of European Commission Role of EMA Secretariat Pharmacovigilance Risk Assessment Committee (PRAC) Committee for Medicinal Products for Human Use (CHMP) Coordination Group for Mutual recognition and Decentralized Fare Procedure clic per modificare Human (CMDh) lo stile del sottotitolo dello schema Specific quality process for CA in MS and Agency Quality system requirements for PhV task delegated by CA in MS 45 The challenge Complex Organizations Cross-company processes Many interfaces (internal and external, i.e. Competent Authority, Agency) Information flows Communication requirements Regulatory risks Protection of public health High level of performance 46

24 The opportunity Make Good Practice as Practice, Invest Quality Thank you! 47

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 1 2 20 February 2012 EMA/541760/2011 3 4 Guideline on good pharmacovigilance practices (GVP) Module I Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration

More information

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 22 June 2012 EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP) Module I Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration with Member

More information

Pharmacovigilance System Master File (PSMF), QPPV and audits

Pharmacovigilance System Master File (PSMF), QPPV and audits Federal Agency for Medicines and Health Products (FAMHP) Pharmacovigilance System Master File (PSMF), QPPV and audits Matthijs Nele, PhV Inspector, DG Inspection BRAS - FAMHP/NM/ 1 Content Introduction

More information

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 9 April 2013 EMA/816573/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module II Pharmacovigilance system master file (Rev 1) Draft of first version finalised by the Agency in collaboration

More information

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 19 April 2013 EMA/813938/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VIII Post-authorisation safety studies (Rev 1) Draft of first version finalised by the Agency in collaboration

More information

Quality in pharmacovigilance systems

Quality in pharmacovigilance systems Quality in pharmacovigilance systems June 20 th, 2014 Lisa Stagi, Medical Compliance Leader Roche Spa Quality systems in pharmacovigilance: legal requirements Regulation 1235/2010 e Directive 2010/84 Legal

More information

Agence fédérale des médicaments et des produits de santé

Agence fédérale des médicaments et des produits de santé Agence fédérale des médicaments et des produits de santé From Risk Management Plan to Risk Minimization Activities New Royal Decree: Status and General Explanation Role of the Pharmacovigilance Department

More information

Questions & answers on signal management

Questions & answers on signal management 23 October 2015 EMA/261758/2013 Inspections and Human Medicines Pharmacovigilance Division This document addresses a number of questions which stakeholders, in particular marketing authorisation holders

More information

EphMRA Adverse Event Reporting Guidelines 2015

EphMRA Adverse Event Reporting Guidelines 2015 EphMRA Adverse Event Reporting Guidelines 2015 Based upon the Guideline on good pharmacovigilance practices (GVP) Module VI Management and reporting of adverse reactions to medicinal products European

More information

Post-authorisation safety studies and the EU PAS Register

Post-authorisation safety studies and the EU PAS Register Post-authorisation safety studies and the EU PAS Register Xavier Kurz European Medicines Agency EMA, 11 October 2012 An agency of the European Union Content of the presentation 1. PASS: definition and

More information

Implementation strategy for ISO IDMP in EU

Implementation strategy for ISO IDMP in EU Implementation strategy for ISO IDMP in EU Paolo Alcini Head of Data Standardisation and Analytics Business Data & Analytics Information Management EMA An agency of the European Union The EU ISO IDMP Task

More information

EudraVigilance stakeholder change management plan

EudraVigilance stakeholder change management plan 26 October 2015 EMA/797114/2014 Information Management Division Consultation of Project Maintenance Group 1 15 July 2015 Consultation of Eudravigilance Expert Working Group 23 September 2015 Consultation

More information

Report to the European Commission on Pharmacovigilance audits carried out in the Medicines Evaluation Board, The Netherlands period of time from

Report to the European Commission on Pharmacovigilance audits carried out in the Medicines Evaluation Board, The Netherlands period of time from Report to the European Commission on Pharmacovigilance audits carried out in the Medicines Evaluation Board, The Netherlands period of time from September 2013 to September 2015 1. INTRODUCTION Applicable

More information

One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency

One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency 8 April 2014 EMA/171322/2014 Pharmacovigilance Department One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency Reporting period: 2 July 2012 to 1 July 2013 7 Westferry

More information

The EMA current activities towards ISO IDMP implementation

The EMA current activities towards ISO IDMP implementation The EMA current activities towards ISO IDMP implementation An overview Ginas meeting 11 June 2014 Presented by: Ilaria Del Seppia, B-BD-DCM EMA An agency of the European Union Outlines EMA Vision: Objectives

More information

EphMRA Adverse Event Reporting Guidelines 2013

EphMRA Adverse Event Reporting Guidelines 2013 EphMRA Adverse Event Reporting Guidelines 2013 Based upon the Guideline on good pharmacovigilance practices (GVP) Module VI Management and reporting of adverse reactions to medicinal products European

More information

EU Individual Case Safety Report (ICSR) 1 Implementation Guide

EU Individual Case Safety Report (ICSR) 1 Implementation Guide 4 December 2014 EMA/51938/2013 EU Individual Case Safety Report (ICSR) 1 Implementation Guide Start of Public Consultation 30 April 2014 End of Public Consultation 30 June 2014 Final draft agreed by Project

More information

Stakeholder Meeting, 7 th June 2013 An inspector s perspective considerations for patient support and reimbursement programmes

Stakeholder Meeting, 7 th June 2013 An inspector s perspective considerations for patient support and reimbursement programmes Stakeholder Meeting, 7 th June 2013 An inspector s perspective considerations for patient support and reimbursement programmes Dr Anya Sookoo, Expert Inspector, Inspections, Enforcement & Standards Division,

More information

QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements. Documentation Requirements. General. Quality Manual. Control of Documents

QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements. Documentation Requirements. General. Quality Manual. Control of Documents Chapter j 38 Self Assessment 729 QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements 1. Establishing and implementing a documented quality management system 2. Implementing a documented quality

More information

MANAGEMENT SYSTEM FOR A NUCLEAR FACILITY

MANAGEMENT SYSTEM FOR A NUCLEAR FACILITY GUIDE YVL A.3 / 2 June 2014 MANAGEMENT SYSTEM FOR A NUCLEAR FACILITY 1 Introduction 5 2 Scope of application 6 3 Management system 6 3.1 Planning, implementation, maintenance, and improvement of the management

More information

ISO 9001 Quality Systems Manual

ISO 9001 Quality Systems Manual ISO 9001 Quality Systems Manual Revision: D Issue Date: March 10, 2004 Introduction Micro Memory Bank, Inc. developed and implemented a Quality Management System in order to document the company s best

More information

Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies

Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies 26 September 2012 EMA/623947/2012 Patient Health Protection Guidance for the format and content of the protocol of non-interventional post-authorisation Introduction From 10 January 2013, marketing authorisation

More information

EUROPEAN INDUSTRIAL PHARMACISTS GROUP

EUROPEAN INDUSTRIAL PHARMACISTS GROUP EUROPEAN INDUSTRIAL PHARMACISTS GROUP Guide to Good Regulatory Practice Acknowledgments: Valérie LACAMOIRE, Conseil Central de la section B de l Ordre des Pharmaciens Kelsey MOWER, Industrial Pharmacists

More information

FINE LOGISTICS. Quality Manual. Document No.: 20008. Revision: A

FINE LOGISTICS. Quality Manual. Document No.: 20008. Revision: A FINE LOGISTICS Quality Manual Document No.: 20008 Revision: A 20008 Rev. A FINE LOGISTICS, Quality Manual Page 1 of 24 Quality Manual: Table of contents Number Section Page 1. GENERAL 3 1.1 Index and revision

More information

Summary of pharmacovigilance system audit report results v2

Summary of pharmacovigilance system audit report results v2 Report to the European Commission on Pharmacovigilance audits carried out in the Irish Medicines Board in Ireland From 21 September 2012 to 20 September 2013 1. INTRODUCTION Article 101 (2) of the Directive

More information

Implementation of a Quality Management System for Aeronautical Information Services -1-

Implementation of a Quality Management System for Aeronautical Information Services -1- Implementation of a Quality Management System for Aeronautical Information Services -1- Implementation of a Quality Management System for Aeronautical Information Services Chapter IV, Quality Management

More information

Regulatory approval routes in the European System for Medicinal Products

Regulatory approval routes in the European System for Medicinal Products Regulatory approval routes in the European System for Medicinal Products Cardiovascular Combination Pharmacotherapy Global Summit, Melbourne, 8 th May 2014 Presented by: Kevin Blake Human Medicines Research

More information

RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING

RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Introduction 2 2. Scope 2 3. Documents to be archived 2 4. Quality of essential documents 10 5.

More information

The information contained in these slides is for general purposes only and presents the state of knowledge at November 30, 2011

The information contained in these slides is for general purposes only and presents the state of knowledge at November 30, 2011 1 The information contained in these slides is for general purposes only and presents the state of knowledge at November 30, 2011 No rights can be derived from this information The Medicines Evaluation

More information

QUALITY MANAGEMENT SYSTEM MANUAL

QUALITY MANAGEMENT SYSTEM MANUAL The online version of this document is controlled. Therefore, all printed versions of this document are unofficial copies. QUALITY MANAGEMENT SYSTEM MANUAL 6901 Charles Street Towson, Maryland 21204 Manual

More information

New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Safeguarding public health New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Tony Orme, Senior GDP Inspector Inspection, Enforcement and Standards Division

More information

ISO 9001:2008 Audit Checklist

ISO 9001:2008 Audit Checklist g GE Power & Water ISO 9001:2008 Audit Checklist Organization Auditor Date Page 1 Std. 4.1 General s a. Are processes identified b. Sequence & interaction of processes determined? c. Criteria for operation

More information

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,

More information

The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor

The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor The Concept of Quality in Clinical Research Dorota Śwituła Senior Clinical Quality Assurance Advisor 1 Agenda What is quality? How we define quality in clinical research? The standard components of a Quality

More information

ICH guideline Q10 on pharmaceutical quality system

ICH guideline Q10 on pharmaceutical quality system September 2015 EMA/CHMP/ICH/214732/2007 Committee for Human Medicinal Products Step 5 Transmission to CHMP May 2007 Transmission to interested parties May 2007 Deadline for comments November 2007 Final

More information

MINISTRY OF THE ENVIRONMENT DRINKING WATER QUALITY MANAGEMENT STANDARD

MINISTRY OF THE ENVIRONMENT DRINKING WATER QUALITY MANAGEMENT STANDARD MINISTRY OF THE ENVIRONMENT DRINKING WATER QUALITY MANAGEMENT STANDARD October 2006 Introduction The Safe Drinking Water Act, 2002 (SDWA) requires Owners and Operating Authorities of municipal residential

More information

Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization

Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization 4.1 Understanding the organization and its context

More information

Quality Manual. UK Wide Security Solutions Ltd. 1 QM-001 Quality Manual Issue 1. January 1, 2011

Quality Manual. UK Wide Security Solutions Ltd. 1 QM-001 Quality Manual Issue 1. January 1, 2011 Quality Manual 1 QM-001 Quality Manual Issue 1 January 1, 2011 This document is uncontrolled when printed. Please verify with Quality Management Representative 16 Dukes Close, West Way, Walworth Industrial

More information

ISO 9001:2000 AUDIT CHECKLIST

ISO 9001:2000 AUDIT CHECKLIST ISO 9001:2000 AUDIT CHECKLIST No. Question Proc. Ref. Comments 4 Quality Management System 4.1 General Requirements 1 Has the organization established, documented, implemented and maintained a quality

More information

CENTRIS CONSULTING. Quality Control Manual

CENTRIS CONSULTING. Quality Control Manual CENTRIS CONSULTING Quality Control Manual ISO 9001:2008 Introduction Centris Consulting developed and implemented a Quality Management System in order to document the company s best business practices,

More information

Site visit inspection report on compliance with HTA minimum standards. Belfast Cord Blood Bank. HTA licensing number 11077.

Site visit inspection report on compliance with HTA minimum standards. Belfast Cord Blood Bank. HTA licensing number 11077. Site visit inspection report on compliance with HTA minimum standards Belfast Cord Blood Bank HTA licensing number 11077 Licensed for the procurement, processing, testing, storage, distribution and import/export

More information

Opinion/ Commission. Notification. Decision. Issued 2 / affected 3 amended on. 30/07/2015 Annex II, Labelling and PL

Opinion/ Commission. Notification. Decision. Issued 2 / affected 3 amended on. 30/07/2015 Annex II, Labelling and PL Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected

More information

Quality Manual. Dynamic Manufacturing 156 Armstrong Drive Freeport, PA 16229. Revision 6 Revision Date: 7/8/2013. www.dynamic-manufacturing.

Quality Manual. Dynamic Manufacturing 156 Armstrong Drive Freeport, PA 16229. Revision 6 Revision Date: 7/8/2013. www.dynamic-manufacturing. Quality Manual Dynamic Manufacturing 156 Armstrong Drive Freeport, PA 16229 www.dynamic-manufacturing.com Page 1 of 5 Statement of Authority Dynamic Manufacturing recognizes its responsibilities to fully

More information

US EPA REGION III QUALITY MANAGEMENT PLAN REVIEW CHECKLIST

US EPA REGION III QUALITY MANAGEMENT PLAN REVIEW CHECKLIST US EPA REGION III Organization: EPA Organization: EPA Program: Contact: EPA Contact: EPA Contract/Grant/IAG Number: Phone Number: Phone Number: Reviewer: Date Reviewed: Reviewer Organization: Check New

More information

Data submission of authorised medicines in the European Union

Data submission of authorised medicines in the European Union 23 February 2015 EMA/471367/2014, Rev. 1 1 Business Data and Support Department Data submission of authorised medicines in the European Union Outlines on Article 57(2) of Regulation (EC) No 726/2004 1

More information

QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES

QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PIC/S September

More information

PHARMACEUTICAL QUALITY SYSTEM Q10

PHARMACEUTICAL QUALITY SYSTEM Q10 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step

More information

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 1 2 20 February 2012 EMA/876333/2011 3 4 Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions Draft finalised by the Agency in collaboration with Member States 7 February 2012 Definitions

More information

Quality Management System Process/ Management Review

Quality Management System Process/ Management Review Directorate in charge: Process concerned: Process owner: Executive Directorate Quality Management System Process/ Management Review Quality Section Manager Véronique Magnier Purpose and Scope of the :

More information

Site visit inspection report on compliance with HTA minimum standards. London School of Hygiene & Tropical Medicine. HTA licensing number 12066

Site visit inspection report on compliance with HTA minimum standards. London School of Hygiene & Tropical Medicine. HTA licensing number 12066 Site visit inspection report on compliance with HTA minimum standards London School of Hygiene & Tropical Medicine HTA licensing number 12066 Licensed under the Human Tissue Act 2004 for the storage of

More information

FMC Technologies Measurement Solutions Inc.

FMC Technologies Measurement Solutions Inc. Table of Contents 1 Revision History... 4 2 Company... 5 2.1 Introduction... 5 2.2 Quality Policy... 6 2.3 Quality Organization... 6 2.4 Company Processes... 7 3 Scope and Exclusions... 8 3.1 Scope...

More information

ISO 9001:2008 Quality Management System Requirements (Third Revision)

ISO 9001:2008 Quality Management System Requirements (Third Revision) ISO 9001:2008 Quality Management System Requirements (Third Revision) Contents Page 1 Scope 1 1.1 General. 1 1.2 Application.. 1 2 Normative references.. 1 3 Terms and definitions. 1 4 Quality management

More information

International Workshop Agreement 2 Quality Management Systems Guidelines for the application of ISO 9001:2000 on education.

International Workshop Agreement 2 Quality Management Systems Guidelines for the application of ISO 9001:2000 on education. ISO 2002 All rights reserved ISO / IWA 2 / WD1 N5 Date: 2002-10-25 Secretariat: SEP-MÉXICO International Workshop Agreement 2 Quality Management Systems Guidelines for the application of ISO 9001:2000

More information

QUALITY MANAGEMENT SYSTEM Corporate

QUALITY MANAGEMENT SYSTEM Corporate Page 1 of 12 4 Quality Management System 4.1 General Requirements The Peerless Pump Quality Management System shall include: Documented statements of a quality policy and of quality objectives; A quality

More information

CORPORATE QUALITY MANUAL

CORPORATE QUALITY MANUAL Corporate Quality Manual Preface The following Corporate Quality Manual is written within the framework of ISO 9001:2008 Quality System by the employees of CyberOptics. CyberOptics recognizes the importance

More information

What is necessary to provide good clinical data for a clinical trial?

What is necessary to provide good clinical data for a clinical trial? What is necessary to provide good clinical data for a clinical trial? Alain Barrois, Assistant Clinical Trials Operations Manager #EBMT2015 www.ebmt.org Is this a (typical) clinical trial? 2 Agenda Introduction

More information

Derbyshire Trading Standards Service Quality Manual

Derbyshire Trading Standards Service Quality Manual Derbyshire Trading Standards Service Quality Manual This Quality Manual has been developed to give a broad outline of how the Trading Standards Division s range of services comply with the requirements

More information

Guidance notes on collection of drug safety information by employees and agents of pharmaceutical companies

Guidance notes on collection of drug safety information by employees and agents of pharmaceutical companies Guidance notes on collection of drug safety information by employees and agents of pharmaceutical companies March 2013 Guidance notes on collection of drug safety information by employees and agents of

More information

Rev: Issue 4 Rev 4 Quality Manual AOP0101 Date: 10/07/13. Quality Manual. CBT Technology, Inc. 358 North Street Randolph, MA 02368

Rev: Issue 4 Rev 4 Quality Manual AOP0101 Date: 10/07/13. Quality Manual. CBT Technology, Inc. 358 North Street Randolph, MA 02368 Quality Manual CBT Technology, Inc. 358 North Street Randolph, MA 02368 Issue 4 Revision 4 Note: updates are in italics Page 1 of 18 1.0 Scope and Exclusions Scope This Quality Manual contains policies

More information

Good practice guide on recording, coding, reporting and assessment of medication errors

Good practice guide on recording, coding, reporting and assessment of medication errors 1 2 3 14 April 2015 EMA/762563/2014 Pharmacovigilance Risk Assessment Committee (PRAC) 4 5 6 Good practice guide on recording, coding, reporting and assessment of medication errors Draft Draft finalised

More information

ASTRAZENECA GLOBAL POLICY QUALITY AND REGULATORY COMPLIANCE

ASTRAZENECA GLOBAL POLICY QUALITY AND REGULATORY COMPLIANCE ASTRAZENECA GLOBAL POLICY QUALITY AND REGULATORY COMPLIANCE THIS POLICY OUTLINES THE TOP LEVEL REQUIREMENTS TO SUPPORT PRODUCT QUALITY IN THE DEVELOPMENT, MANUFACTURE AND DISTRIBUTION OF ACTIVE PHARMACEUTICAL

More information

Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals

Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals Pharmacovigilance costs 0.12%-0.22% of hospital admissions

More information

15 Guiding Principles

15 Guiding Principles Health, Safety, Environment and Corporate Social Responsibility 15 Guiding Principles 2013 Message from President and CEO 0 New Gold has a complementary portfolio of assets in different countries and cultures

More information

Working Party on Control of Medicines and Inspections. Final Version of Annex 16 to the EU Guide to Good Manufacturing Practice

Working Party on Control of Medicines and Inspections. Final Version of Annex 16 to the EU Guide to Good Manufacturing Practice Version 8 (final) EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 S\common\legal-legislation\75-319nd81-851\91-356\eudralexvol4\Annex

More information

The Clinical Trials Regulation EU No 536/2014: and Phase I trials

The Clinical Trials Regulation EU No 536/2014: and Phase I trials The Clinical Trials Regulation EU No 536/2014: and Phase I trials EUFEMED, Brussels, 20 May 2015 Presented by Fergus Sweeney Head, Inspections and Human Medicines Pharmacovigilance An agency of the European

More information

Quality Management System Manual

Quality Management System Manual Quality Management System Manual This manual has been reviewed and approved for use by: Jack Zazulak President, Aurora Machine Limited March 07, 2011 Date - Copyright Notice - This document is the exclusive

More information

ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL

ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL 8200 Brownleigh Drive Raleigh, NC 27617-7423 Phone: (919) 510-9696 Fax: (919) 510-9668 ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL ALLIANCE OF PROFESSIONALS & CONSULTANTS, INC. - 1 - Table of Contents

More information

Comparison of EU-Pharmacovigilance System Master File (PSMF) with US System

Comparison of EU-Pharmacovigilance System Master File (PSMF) with US System Comparison of EU-Pharmacovigilance System Master File (PSMF) with US System Wissenschaftliche Prüfungsarbeit Zur Eralngung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen

More information

INTERNATIONAL STANDARD

INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 9001 Fourth edition 2008-11-15 Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 9001:2008(E) ISO 2008 PDF disclaimer

More information

QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC.

QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. Hattiesburg, MS Revision E 01/19/11 Revised to ISO 9001:2008 on July 9, 2009 JPM OF MISSISSIPPI, INC. MANAGEMENT QUALITY POLICY It is the goal of JPM of

More information

ISO/IEC 17025 QUALITY MANUAL

ISO/IEC 17025 QUALITY MANUAL 1800 NW 169 th Pl, Beaverton, OR 97006 Revision F Date: 9/18/06 PAGE 1 OF 18 TABLE OF CONTENTS Quality Manual Section Applicable ISO/IEC 17025:2005 clause(s) Page Quality Policy 4.2.2 3 Introduction 4

More information

Community Lifestyle Support Inc.

Community Lifestyle Support Inc. HUMAN SERVICES QUALITY FRAMEWORK STANDARDS - POLICIES DOCUMENT Q:/1 DATE REVEIWED: REFERENCE: GOVERNANCE AND August 2014 MANAGEMENT POLICY AUTHORISATION: STANDARD REFERENCE: NEXT REVIEW DATE: Management

More information

Guidance notes. for Patient Safety and Pharmacovigilance in Patient Support Programmes

Guidance notes. for Patient Safety and Pharmacovigilance in Patient Support Programmes Guidance notes for Patient Safety and Pharmacovigilance in Patient Support Programmes 9 May 2011 Approval Status Authors The ABPI Pharmacovigilance Expert Network Change History N/A Approval Date 9 May

More information

Row Manufacturing Inc. Quality Manual ISO 9001:2008

Row Manufacturing Inc. Quality Manual ISO 9001:2008 Row Manufacturing Inc. Quality Manual ISO 9001:2008 Row Manufacturing 210 Durham Drive Athens, Alabama 35611 Phone:256.232.4151 Fax:256.232.4133 Page 2 of 33 This Page intentionally left Blank Page 3 of

More information

The European regulatory system for medicines and the European Medicines Agency

The European regulatory system for medicines and the European Medicines Agency The European regulatory system for medicines and the European Medicines Agency A consistent approach to medicines regulation across the European Union An agency of the European Union This booklet is intended

More information

EMA pharmacovigilance system manual

EMA pharmacovigilance system manual 30 June 2014 EMA/623550/2013 Inspections and Human Medicines Pharmacovigilance Division Version 1.1 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile

More information

QUALITY MANUAL 3 KENDRICK ROAD WAREHAM, MA 02571 508-295-9591 FAX 508-295-6752

QUALITY MANUAL 3 KENDRICK ROAD WAREHAM, MA 02571 508-295-9591 FAX 508-295-6752 QUALITY MANUAL 3 KENDRICK ROAD WAREHAM, MA 02571 508-295-9591 FAX 508-295-6752 Section 1. REVISION STATUS Revision 01 Initial Issue 02/13/95 Revision 02 ECO No.Q-0032 05/07/96 Revision 03 ECO No.97171

More information

The European Medicines Agency s Integrated Quality Management System

The European Medicines Agency s Integrated Quality Management System European Medicines Agency POLICY/0001 EMEA/MB/355781/2007Rev.1 The European Medicines Agency s Integrated Quality Management System 1. Introduction and purpose This policy describes the purpose and structure

More information

16) QUALITY MANAGEMENT SYSTEMS

16) QUALITY MANAGEMENT SYSTEMS INTRODUCTION 16) QUALITY MANAGEMENT SYSTEMS The aim of this paper is to give a brief introduction to the idea of a quality management system and specifically in ISO 9001:2000: Quality Management System.

More information

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 22 June 2012 EMA/827661/2011 Guideline on good pharmacovigilance practices (GVP) Module IX Signal management Draft finalised by the Agency in collaboration with Member States and submitted to ERMS FG 19

More information

Voluntary Certification Scheme for Traditional Health Practitioner

Voluntary Certification Scheme for Traditional Health Practitioner ANNEX-3 Voluntary Certification Scheme for Traditional Health Practitioner 0. Introduction 0.1 This document defines the criteria to be followed by the bodies certifying persons against specific requirements,

More information

Clinical trials: from European perspective to National implementation. CTFG / FAMHP / pharma.be. Brussels, 19 November 2010

Clinical trials: from European perspective to National implementation. CTFG / FAMHP / pharma.be. Brussels, 19 November 2010 Clinical trials: from European perspective to National implementation CTFG / FAMHP / pharma.be Brussels, 19 November 2010 Safety in clinical trials: From detection to decision How safety events are captured

More information

European Forum for Good Clinical Practice Audit Working Party

European Forum for Good Clinical Practice Audit Working Party European Forum for Good Clinical Practice Audit Working Party REVISION OF THE ENGAGE 1 AUDITING GUIDELINE. AN OPTIONAL GUIDELINE FOR GCP COMPLIANCE AND QUALITY MANAGEMENT SYSTEMS AUDITING This document

More information

FINAL DOCUMENT. Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 1: General Requirements

FINAL DOCUMENT. Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 1: General Requirements GHTF/SG4/N28R4:2008 FINAL DOCUMENT Title: Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Authoring Group: GHTF Study Group 4 Endorsed by: The Global Harmonization

More information

Checklist. Standard for Medical Laboratory

Checklist. Standard for Medical Laboratory Checklist Standard for Medical Laboratory Name of hospital..name of Laboratory..... Name. Position / Title...... DD/MM/YY.Revision... 1. Organization and Management 1. Laboratory shall have the organizational

More information

ISO 9001 : 2008 QUALITY MANAGEMENT SYSTEM AUDIT CHECK LIST INTRODUCTION

ISO 9001 : 2008 QUALITY MANAGEMENT SYSTEM AUDIT CHECK LIST INTRODUCTION INTRODUCTION What auditors should look for: the items listed in these headings that the ISO requirement is met that the requirement is met in the manner described in the organization's documentation Page

More information

Eagle Machining, Inc. Quality Management System

Eagle Machining, Inc. Quality Management System Eagle Machining, Inc. Quality Management System 1 of 10310 Antoine Drive Bldg D, Houston, Texas 77086 BUSINESS OPERATING MANUAL (QUALITY MANUAL) Revision Date: 08/01/2014 Approved By: Joseph Vu Date: 08/01/2014

More information

Micro Plastics, Inc. Quality Manual

Micro Plastics, Inc. Quality Manual ISO 9001:2008 11 Industry Lane Flippin, Arkansas 72634 QM-001-2008-F Page 2 of 39 Introduction Micro Plastics, Inc. developed and implemented a Quality Management System in order to document the company

More information

File:Quality-Management Manual-V2

File:Quality-Management Manual-V2 Quality- Management Manual ChenYang Technologies Gmbh & Co.KG Markt Schwabener Str. 8 85464 Finsing Telephone:: 08121/ 25 74 100 Fax:: 08121 / 25 74 101 E-Mail: info@chenyang.de Internet: www.chenyang.de

More information

Appendix 3 (normative) High level structure, identical core text, common terms and core definitions

Appendix 3 (normative) High level structure, identical core text, common terms and core definitions Appendix 3 (normative) High level structure, identical core text, common terms and core definitions NOTE In the Identical text proposals, XXX = an MSS discipline specific qualifier (e.g. energy, road traffic

More information

Quality Manual ALABAMA RESEARCH & DEVELOPMENT. This Quality Manual complies with the Requirements of ISO 9001:2008.

Quality Manual ALABAMA RESEARCH & DEVELOPMENT. This Quality Manual complies with the Requirements of ISO 9001:2008. ALABAMA RESEARCH & DEVELOPMENT This complies with the Requirements of ISO 9001:2008. Prepared By: Phyllis Olsen Release Date: 03/19/09 Quality Policy & Objectives s quality policy is to achieve sustained,

More information

Disclosure to Promote the Right To Information

Disclosure to Promote the Right To Information इ टरन ट म नक Disclosure to Promote the Right To Information Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information

More information

Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency

Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency 28 August 2015 EMA/386784/2015 Inspections and Human Medicines Pharmacovigilance Division Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the

More information

EA IAF/ILAC Guidance. on the Application of ISO/IEC 17020:1998

EA IAF/ILAC Guidance. on the Application of ISO/IEC 17020:1998 Publication Reference EA IAF/ILAC-A4: 2004 EA IAF/ILAC Guidance on the Application of ISO/IEC 17020:1998 PURPOSE This guidance document is for ISO/IEC 17020: General Criteria for the operation of various

More information

Medical Information and Pharmacovigilance through acquisition. Lisa Hughes Medical Affairs Manager Actavis UK Ltd

Medical Information and Pharmacovigilance through acquisition. Lisa Hughes Medical Affairs Manager Actavis UK Ltd Medical Information and Pharmacovigilance through acquisition Lisa Hughes Medical Affairs Manager Actavis UK Ltd Disclaimer The views and opinions expressed in the following presentation are those of the

More information

Electronic exchanges of individual case safety reports (ICSRs) with ANSM (National Agency of Medicine and Health Product safety)

Electronic exchanges of individual case safety reports (ICSRs) with ANSM (National Agency of Medicine and Health Product safety) Pharmacovigilance information for pharmaceutical companies Electronic exchanges of individual case safety reports (ICSRs) with ANSM (National Agency of Medicine and Health Product safety) This document

More information

Quality Assurance. Disclosure for Lilli Møller Andersen. No relevant financial relationships exist for any issue mentioned in this presentation

Quality Assurance. Disclosure for Lilli Møller Andersen. No relevant financial relationships exist for any issue mentioned in this presentation Quality Assurance Disclosure for Lilli Møller Andersen No relevant financial relationships exist for any issue mentioned in this presentation Agenda Quality Assurance Quality Management System Quality

More information

ISO 9001:2000 Gap Analysis Checklist

ISO 9001:2000 Gap Analysis Checklist ISO 9001:2000 Gap Analysis Checklist Type: Assessor: ISO 9001 REQUIREMENTS STATUS ACTION/COMMENTS 4 Quality Management System 4.1 General Requirements Processes needed for the quality management system

More information

AEROSPACE STANDARD. Quality Management Systems - Requirements for Aviation, Space and Defense Organizations RATIONALE

AEROSPACE STANDARD. Quality Management Systems - Requirements for Aviation, Space and Defense Organizations RATIONALE AEROSPACE STANDARD AS9100C Issued 1999-11 Revised 2009-01 Superseding AS9100B Quality Management Systems - Requirements for Aviation, Space and Defense Organizations RATIONALE This standard has been revised

More information

Guidance for Industry. Q10 Pharmaceutical Quality System

Guidance for Industry. Q10 Pharmaceutical Quality System Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation

More information