The Quality System for Drugs in Germany
|
|
|
- Leslie Welch
- 10 years ago
- Views:
Transcription
1 The Quality System for Drugs in Germany Prof. Dr. Harald G. Schweim Head of Department for Drug Regulatory Affairs Institute for Pharmacy, University of Bonn Former President of the German Federal Institute for Drugs and Medical Devices (BfArM) Former Director of the German Institute of Medical Documentation and Information (DIMDI)
2 Steps for a quality system Decision for a quality system Quality Management Manual: 17 guidelines Draft documents for a Quality Assurance System in GMP Approval of Quality Policy Implementation and Test Phase First Revision of Documents; ongoing Extension of System planned for supervision of - GCP - veterinary medicinal products - wholesalers - pharmacies
3 Underlying standards 1. PIC/S: Recommendations on quality system requirements for GMP inspectorates (PH 7/94; current updated version 2. European Norms EN (1995) EN (1989) 3. DIN/ISO Norms ISO 9002 (1994) 4. Compilation of community procedures on administrative collaboration and harmonisation of inspections (2001) (
4 EU- Compilation of Community procedures cover... Training of inspectors Manufacturing authorisations Inspection planning Inspection performance, follow-up Inspection report Action in cases of non-compliance/ defect products (RAS*) Sampling Internal Audits *Rapid Alert System
5 Structure of Quality System Policy Statement Quality Management Manual (QMM) Statement for quality policy 17 Qualityguidelines Quality Assurance Manual (QAM) SOPs AIMs
6 QM-Manual: Quality Guidelines Frame conditions for a detailed quality system (responsibilities, organisation and management, personnel, documentation, change control, inspection systems, equipment, quality manuals, transparency, audits, complaint handling, sub-contracting, cooperation, sampling and testing, certificates) Decided and approved on political level
7 Quality Guidelines (1) 1. Responsibility of the upper management 2. Administrative provisions 3. Organisation and management 4. Personnel 5. Documentation 6. Change control 7. Inspection procedures 8. Required equipment / resources 9. Quality assurance manual 10. Confidence building and transparency
8 Quality Guidelines (2) 11. Internal quality audit and regular checks (management review) 12. Administrative actions for deficiencies and defects 13. Handling of mistakes, complaint management 14. Delegation of tasks 15. Licensing 16. Cooperation 17. Testing of samples
9 QA-Manual: SOPs /Aide mémoires 32 SOPs (Standard Operating Procedures) (qualification and training of inspectors, manufacturing / import authorisation, inspection performance, inspection planning, certificates,...) 8 Aide mémoires (sterile drugs, biotechnology, computerized systems, blood products, active ingredients,...) Developed on an expert level
10 Specific Procedures Staff training and designation of GMP inspectors appointment of QA responsibilities avoidance of conflict of interest ongoing training job descriptions assessment and maintenance of qualification
11 Inspections inspection plan conduct of inspections inspection report Site Master File teams sampling Aides memoire
12 Aides mémoire for Inspections inspection of manufacturers biotechnology qualification and validation inspection of blood banks manufacturers of sterile products computerised systems API manufacturers
13 Quality Defects management of drug risks/ incidents, consumer complaints, other complaints corrective action in case of defects and deficiencies evaluation of deviations, deficiencies and defects
14 Authorisations/Certificates manufacturing authorisation WHO certificate certificate for API import authorisation certificate acc. section 72a AMG
15 Drug Testing official testing of samples OOS results validation of analytical procedures
16 Training and Designation of GMP Inspectors 1. Basic qualification: pharmacists veterinarian (only for vet. prod.) 2. Baseline Training: 2 years in an inspectorate of which 6 months may be in OMCL, Länder ministry, Federal Ministry, quality lab (ZLG) 3. Theory: as in Compilation of community procedures Practical training: at least 10 joint inspections with senior inspector 5. Final exam inspection 6. Formal designation
17 Ongoing Training 1. At least 10 days per year, e.g.: Conferences (e.g. PIC/S, commercial conferences) German annual conference Expert group trainings Joint inspections/ joint visits Local SOP training sessions 2. Formal documentation in personal file
18 Assessment and Maintenance of Qualification Every 5 years by head of inspectorate Assessment may be covered by: - Quality audit - Evaluation of inspection reports - participation in inspections Possible actions: - specific training - participation in inspections in other inspectorates - suspension or revocation of designation
19 SOP : Sampling Sampling plan by OMCL in cooperation with inspectorate Analytical evaluation of risk products within 5 years after approvals Risk products : New chemical entity API with narrow therapeutic range API with low stability Dosage form with specific technological properties/ problems
20 Audit Systems : Audits 1. Subject: Inspectorates 2. Biannual cycle: Organisation Procedures Quality System 3. Auditors: at least 2 at least 1 GMP inspector 4. Corrective Action : to be proceeded to management to be evaluated by auditors
21 Inspections of API* manufacturers in Germany Legal requirements: Under scope of centralised procedure National level: only APIs of human and animal origin; biotec APIs After publication of Ordinance: all APIs Practical implementation Voluntary inspections of API manufacturers Voluntary 3 rd country inspections * Advanced Pharmaceutical Industry
22 Conclusions: What we learnt about the process... to give enough time for discussions on all levels to make sure that all parties involved have enough time to make contributions to make sure that contributions are clearly evaluated to allow for 70 % accuracy at the beginning to allow for a pilot phase in order to collect practical experiences to intensively monitor the implementation phase to adjust immediately where necessary
23 Thank you for your attention!
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
Compilation of Community Procedures on Inspections and Exchange of Information
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Public Health and Risk Assessment Pharmaceuticals 3 October 2014 EMA/572454/2014 Rev 17 Compliance and Inspection Compilation of Community
Compilation of Community Procedures on Inspections and Exchange of Information
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Public Health and Risk Assessment Pharmaceuticals 27 June 2013 EMA/385898/2013 Rev 16 Compliance and Inspection Compilation of Community
Author General Management Quality Assurance
Lab Ofichem B.V. Pag.: 1 / 14 Date: 20-01- Version: 02 Status: geldig Contents 1. General... 2 2. Shared Third Party audit program... 3 3. Reassurance absence of Conflict of Interest... 5 4. Contract structure...
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance
Recent Updates on European Requirements and what QPs are expected to do
Recent Updates on European Requirements and what QPs are expected to do QP Forum 28/29 November 2013, Lisbon Dr. Bernd Renger Modified: Georg Goestl 1 Written Conformation for API-Import Actual Status
Guidance for Industry: Starting Material Supplier Management
Guidance for Industry: Starting Material Supplier Management Version 1.0 Drug Office Department of Health. Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. Selecting and
World Health Organization Prequalification of Medicines
Dr André van Zyl World Health Organization Prequalification of Medicines Manufacturers meeting April 2011 Head of Inspections [email protected] 1 WHO GMP In this presentation: Background and Introduction
Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
1 2 3 5 August 2011 EMA/INS/GCP/600788/2011 Compliance and Inspection 4 5 6 7 Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 010-4 3 Appendices 1 January 2011 STANDARD OPERATING PROCEDURE PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING
CONCEPT HEIDELBERG. Pharmaceutical Quality Training. Conferences. Services.
CONCEPT HEIDELBERG Pharmaceutical Quality Training. Conferences. Services. About Us Helping you to Comply with GMP Since our foundation on 1 April 1978, CONCEPT HEIDELBERG has been concentrating on providing
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
Adoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012
10 December 2013 EMA/INS/GCP/600788/2011 Compliance and Inspection Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular
Annex 7 Guidelines on pre-approval inspections
World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the
Library Guide: Pharmaceutical GMPs
Library Guide: Pharmaceutical GMPs Table of Contents Overview...3 Courses Listed by Functional Area... 4 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)... 7 A Tour of the FDA
GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group [email protected]
GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group [email protected] Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process
Introduction to Q10 Pharmaceutical Quality System
ICH-GCG Asean Training Workshop on ICH Guidelines Q8,Q9 and Q10 (New Paradigm) Introduction to Q10 Pharmaceutical Quality System Georges FRANCE, Q- IWG Kuala Lumpur, Malaysia 26-28 July 2010 International
EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond
EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond 14 th International Conference of Drug Regulatory Authorities Pre-ICDRA Meeting Dr Susanne Keitel European Directorate
Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives. Barry A. Friedman, Ph.D. Consultant
Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives Barry A. Friedman, Ph.D. Consultant FDA Overview FDA is a consumer protection agency within the Department of Health & Human
Work plan for GMP/GDP Inspectors Working Group for 2016
21 December 2015 EMA/INS/GMP/738756/2015 Compliance and Inspection Work plan for GMP/GDP Inspectors Working Group for 2016 Chairperson: Status David Cockburn January 2016 1. Meetings scheduled for 2016
GMP Pharma BV. Netherlands
GMP Pharma BV Netherlands Connecting the European & Indian Pharmaceutical, Biotechnology and Biopharmaceutical Industry for parallel growth and solicitation. About Us: GMP Pharma BV is a multisource organization
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
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
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
GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES. Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme
GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme Contents 1. Why good documentation is essential? 2. What constitutes
UNICEF s Quality Assurance System for procurement of medicines
UNICEF s Quality Assurance System for procurement of medicines QA Specialist Peter Svarrer Jakobsen Joint UNICEF, UNFPA and WHO Meeting with Manufacturers and Suppliers UN City, Copenhagen 23 September
Auditing as a Component of a Pharmaceutical Quality System
Auditing as a Component of a Pharmaceutical Quality System Tim Fields Conducting internal audits (or self inspections) and external audits of suppliers and outsourcing operations are key elements of a
Establishing Quality Management Systems
Establishing Quality Management Systems Dr. Petra Dörr Head of Management Services and Networking Swissmedic, Swiss Agency for Therapeutic Products [email protected] 14th ICDRA Workshop H 2 December
GMP Training Course Quality Control. 20-21 October 2009. Lesley Graham Senior Inspector (UK)
GMP Training Course Quality Control 20-21 October 2009 Lesley Graham Senior Inspector (UK) Quality Control GMP in the QC Laboratory Certificates of Analysis Dealing with out of specification results Parametric
Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions
WELCOME Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions Contents: Introduction GMP Audit GMP Audit plan GMP Auditing
ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 038-1 26 March 2012 AIDE-MEMOIRE ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PIC/S March 2012 Reproduction
Medical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day
Medical Devices Notified Bodies and the CE certification Process for Medical Devices European Surgical Robotics Demonstration Day 27 th March 2014, Leuven, Belgium 1 Bart Mersseman Product Manager Medical
Draft guidance for registered pharmacies providing internet and distance sale, supply or service provision
Draft guidance for registered pharmacies providing internet and distance sale, supply or service provision September 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy
John Keel, CPA State Auditor. An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy. August 2015 Report No.
John Keel, CPA State Auditor An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy Report No. 15-039 An Audit Report on Inspections of Compounding Pharmacies at the Board of
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
Overview of Pre-Approval Inspections
Overview of Pre-Approval Inspections Presented by: Kelli F. Dobilas NWJ-DO Pre-Approval Manager Pre-Approval Drug Inspections What are Pre-Approval Inspections? One of the last reviews of the drug approval
Comparison of EU GMP guidelines with WHO guidelines Identification of the cost-intensive requirements
Comparison of EU GMP guidelines with WHO guidelines Identification of the cost-intensive requirements Dr. Dirk Feldmann Prof. Dr. Hans-Jörg Müller Aim of the study I.) Comparison of the EU and WHO GMP
Introduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6
Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication
[email protected] 714 282-1014 Jeff Yuen and Associates, Inc. PO Box 6026 Orange, CA 92863 Terri Dodds CAPT. (RET) TERRI L.
SKILLS/SPECIAL QUALIFICATIONS: Regulatory Expertise: Technical Expertise: CAPT. (RET) TERRI L. DODDS - BSN, RN Former Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals,
INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS
INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS About this document This document is a guide to show what the Inspectorate may look for during an inspection visit. It is intended for use by the GPhC
Audit Report in the framework of the APIC Audit Programme
Audit Report in the framework of the APIC Audit Programme Company Location Address Country Subject of Audit Audit Date Auditor (lead) Co-Auditor(s) Participants Signature of Auditor(s) Lead Auditor Co-Auditor
OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT
OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (06) 72 2R (FORM/158-Rev.02) STANDARD AIDE-MEMOIRE FOR THE MJA/MJV OF OMCLs Full document title and reference Document type
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
ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS
ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:
EU GMP Requirements - Quality Systems - Bernd Boedecker GMP Inspectorate of Hannover / Germany at Turkish Ministry of Health Ankara, 20-21 Oct 2009
EU GMP Requirements - Quality Systems - Bernd Boedecker GMP Inspectorate of Hannover / Germany at Turkish Ministry of Health Ankara, 20-21 Oct 2009 contact data Bernd Boedecker Staatliches Gewerbeaufsichtsamt
Resources Based, Manufacturing and Consumer Goods Industries Chemicals Industry
EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Resources Based, Manufacturing and Consumer Goods Industries Chemicals Industry Version March 2015 QUESTIONS
The FDA recently announced a significant
This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction
TRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP
DISCLAIMER: The EU reserves the right to make subsequent modifications to this text and to complement its proposals at a later stage, by modifying, supplementing or withdrawing all, or any part, at any
Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015
Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 *QP Code of Practice 2008 updated Aug15 Page 1 of 13 Code of Practice for Qualified Persons 1. INTRODUCTION 2.
1 The quality management system (QMS) is the corner stone of compliance to GMP. The QMS is made up of several documents, that when followed ensures the GMP compliance of the process, facility and company.
A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program
A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry CLEANING VALIDATION Instructors Loh Kean Chong Rick Ng Date and Time
Harmonizing Change Control Processes Globally
Quality & Compliance Associates, LLC Harmonizing Change Control Processes Globally President Quality & Compliance Associates, LLC When We Deal In A Global Environment, How Do We Design A System That Addresses
OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT
OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT PA/PH/OMCL (08) 69 3R Full document title and reference Document type VALIDATION OF COMPUTERISED SYSTEMS Legislative basis - CORE DOCUMENT
Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet
Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet April 2015 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians
OECD Series on Principles of GLP and Compliance Monitoring Number 8 (Revised)
Unclassified ENV/JM/MONO(99)24 ENV/JM/MONO(99)24 Or. Eng. Unclassified Organisation de Coopération et de Développement Economiques OLIS : 14-Sep-1999 Organisation for Economic Co-operation and Development
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
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
Working Party on Control of Medicines and Inspections. Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 Working Party on Control
GMP Issues for Start-Ups, quality in the supply chain and role of the Qualified Person (QP)
GMP Issues for Start-Ups, quality in the supply chain and role of the Qualified Person (QP) Presented by: Patrick Costello Scientific Administrator, European Medicines Agency An agency of the European
Session 6: WHO Prequalification Programme. Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs
Session 6: WHO Prequalification Programme Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs Session adapted from the WHO training workshop on prequalification and the WHO technical briefing seminar
Draft guidance for registered pharmacies preparing unlicensed medicines
Draft guidance for registered pharmacies preparing unlicensed medicines January 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians and registered pharmacies
How companies leverage quality and quality certifications to achieve competitive advantage
How companies leverage quality and quality certifications to achieve competitive advantage Eize de Boer Systems & Services Certification International Business Development Manager Pharma Supply Chain for
ICH Q10 Pharmaceutical Quality System (PQS)
ICH Q10 Pharmaceutical Quality System (PQS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Q10 PQS Guideline Background Objectives
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
gsop-32-02 - Vendor Assessment SOP page 1 of 10
gsop-32-02 - Vendor Assessment SOP page 1 of 10 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust VENDOR ASSESSMENT Research & Development
Assist Members in developing their own national arrangements through being able to draw on and hence benefit from the experience of other members;
Introduction IFIAR is an organization of independent audit regulators (hereinafter, audit regulators ). The organization s primary aim is to enable its Members to share information regarding the audit
QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES
QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES Why are Pharmacopoeias so important in a globalised world? Pharmacopoeias have historically provided collections of medical recipes intended to ensure accurate
Managing Risk in Clinical Research. Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey
Managing Risk in Clinical Research Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Aim of the session To explore the risks associated with clinical research and understand how
Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity
Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good
Extemporaneously Prepared Early Phase Clinical Trial Materials
Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS, RAC Eli Lilly & Co. Regulatory Advisor International Consortium for Innovation & Quality in Pharmaceutical Development
Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples
28 February 2012 EMA/INS/GCP/532137/2010 GCP Inspectors Working Group Reflection paper for laboratories that perform the analysis or evaluation of clinical trial Draft agreed by GCP Inspectors Working
Annex 10 Procedure for prequalification of pharmaceutical products
World Health Organization WHO Technical Report Series, No. 961, 2011 Annex 10 Procedure for prequalification of pharmaceutical products 1. Introduction 2. Glossary 3. Purpose and principles 4. Steps of
Responsibilities of Test Facility Management & Sponsor Rik Hendriks Werner Coussement
Responsibilities of Test Facility Management & Sponsor Rik Hendriks Werner Coussement J&J R&DQA, Beerse, Belgium [email protected] J&J GPCD, Beerse, Belgium [email protected] Responsibilities
Quality Risk Management
PS/INF 1/2010 * * Quality Risk Management Quality Risk Management Implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S Document > Authors: L. Viornery (AFSSAPS) Ph.
Staying Current in Cold Chain Management
Staying Current in Cold Chain Management Changes to USP, EU GDPs and Storage and Shipping Practices for Drugs Table of Contents AUTHORS...3 Paul Daniel...3 Piritta Maunu...3 EDITOR...3 John Ferreira...3
COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS
COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS Primer CONTENTS INTRODUCTION...3 QUALITY AND COMPLIANCE IN QUALITY CONTROL LABORATORIES...5 Compliance
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
Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems
14 September 2012 /590745/2012 Patient Health Protection Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP 1. Introduction Ensuring the security and Good Manufacturing
Seminario SSFA. New Guideline on Good Pharmacovigilance Practice (GVP) Fare clic per modificare lo stile del sottotitolo dello schema
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
PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013)
January 2013 RESTRICTED PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) DRAFT FOR COMMENTS Please address any comments on this proposal
Good Research Practice
Page 1 of 8 The Royal Veterinary College Introduction Preface Good Research Practice Funding bodies need to be assured of the quality and validity of research they fund and ensure their contractors are
Med-Info. Introduction to Korean Medical Device regulations. TÜV SÜD Product Service GmbH
Med-Info International expert information for the Medical Device industry Introduction to Korean Medical Device regulations The Ministry of Health and Welfare (MHW) is the healthcare agency having overall
20-21 May 2015, Lisbon, Portugal. Highlights. Speakers:
Speakers: Dr Afshin Hosseiny Chair of the ECA Expert Working Group on GDP, Tabriz Consulting Comply with the new EU GDP Guideline Dr Martin Egger Pharmaserv Dr Daniel Müller GMP/GDP Inspector All participants
EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES
EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES Introduction The WHO Prequalification of Medicines Programme (PQP) was established to provide UN
The Global Guideline for GCP Audit
The Global Guideline for GCP Audit Author: JSQA: Hiroyasu Yamashita, e-mail: [email protected] Reviewed and Acknowledged by: BARQA: Patricia Fitzgerald, e-mail: [email protected]
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
Monitoring. Compliant and Reasonable. 5-6 May 2015, Berlin, Germany
Environmental Monitoring Workshops How to Establish an Environmental Monitoring Programme Interpretation of OOS Results Compliant and Reasonable 5-6 May 2015, Berlin, Germany SPEAKERS: Oxoid, UK Sauflon
Electronic GMP Systems
Electronic GMP Systems Specification - Implementation Validation 18 20 March 2015, Prague, Czech Republic SPEAKERS: Kai Kiefer fme AG, Germany Dr Bob McDowall McDowall Consulting, UK LEARNING OBJECTIVES:
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products- authorisations, European Medicines Agency Brussels, EudraLex The Rules Governing Medicinal
This interpretation of the revised Annex
Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2011, Vol. 31 No. 4 www.ispe.org Copyright ISPE 2011 The ISPE GAMP Community of Practice (COP) provides its interpretation
GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors
GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors This course is a distance-learning program that will culminate in a Graduate
Deviation and Out of Specification Handling
Deviation and Out of Specification Handling APV Training Course GMP Requirements June,10th to11th 2004 Istanbul, Turkey Dr. Jürgen Mählitz GMP Inspector Fronhof 10 D-86152 Augsburg Germany Dr. Jürgen Mählitz
STANDARD OPERATING PROCEDURE FOR RESEARCH. 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol
Managing challenges in early drug development: Biologicals and small molecules
AGAH and Club Phase-I: 3rd Joint Annual Meeting Managing challenges in early drug development: Biologicals and small molecules Tuesday, April 28, 2009 and Wednesday, April 29, 2009 ESPACE TETE D`OR, LYON,
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
GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 032-2 8 January 2010 RECOMMENDATION GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE
New Investigator Collaborations and Interactions: Regulatory
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials
MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This