The Formalized Risk Assessment for Excipients A Practical Approach. Frithjof Holtz, IPEC Europe Vice-Chair, Merck
|
|
|
- Dortha Evans
- 7 years ago
- Views:
Transcription
1 The Formalized Risk Assessment for Excipients A Practical Approach Frithjof Holtz, IPEC Europe Vice-Chair, Merck
2 Presentation Overview Regulatory Background EU FMD and Formalized Risk Assessment Proposal for Risk Assessment Model Summary 05. Feb IPEC Europe Excipient Forum 2
3 Directive 2011/62/EU (EU Falsified Medicines Directive)* Art. 46 f The holder of the manufacturing authorization shall ensure that the excipients are suitable for use in medicinal products by ascertaining the appropriate good manufacturing practice on the basis of a formalized risk assessment. In this risk assessment, the holder of the manufacturing authorization shall take into account the source and intended use of the excipients and previous incidents. Art. 47 Guideline for formalized risk assessment for ascertaining of appropriate GMP for excipients shall be adopted by the Commission in accordance to Art 46 f. *Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products 05. Feb IPEC Europe Excipient Forum 3
4 Guideline on Risk Assessment for Excipients EU Commission published 06/02/2013 Guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (SANCO/D/6/SF/mg/ddg1.d.6(2013)179263; ) Stakeholders are invited to comment on this draft by 30 April 2013 at the latest. Responses should be sent preferably by to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels. 05. Feb IPEC Europe Excipient Forum 4
5 Risk Assessment Guidelines for Excipients The draft guideline is split into three sections Determination of Appropriate GMP based on type of Excipient Determination of Excipient Manufacturer's Risk Profile Confirmation of Application of Appropriate GMP Draft Guideline from EC (SANCO/D/6/SF/mg/ddg1.d.6(2013)179263) 05. Feb IPEC Europe Excipient Forum 5
6 Determination of appropriate GMP based on Type of Excipient For each excipient used the Manufacturing Authorisation Holder should identify the risks presented to the quality, safety and function of each excipient from its source (be that animal, mineral, vegetable, synthetic etc.) through to incorporation in the finished pharmaceutical dose form. Recommended that ICH Q9 principles are used to assess the risks presented to the quality, safety and function of each excipient and to classify the excipient in question as low risk, medium risk or high risk. Draft Guideline from EC (SANCO/D/6/SF/mg/ddg1.d.6(2013)179263) 05. Feb IPEC Europe Excipient Forum 6
7 Determination of appropriate GMP based on Type of Excipient Areas for consideration would include: TSE Potential for viral contamination Potential for microbiological or endotoxin/pyrogen contamination Potential, in general, for any impurity originating from the raw materials (e.g. aflatoxins, pesticides) or generated as part of the process and carried over (e.g. residual solvents and catalysts) Sterility Assurance (for excipients claimed to be sterile) Use of dedicated equipment and or facilities Environmental control and storage conditions Draft Guideline from EC (SANCO/D/6/SF/mg/ddg1.d.6(2013)179263) 05. Feb IPEC Europe Excipient Forum 7
8 Determination of appropriate GMP based on Type of Excipient Additionally with respect to the use and function of each excipient the Manufacturing Authorisation Holder must also consider: The pharmaceutical form and use of the medicinal product containing the excipient (e.g. ointment product, injection/infusion etc.) The function of the excipient in the formulation (e.g. lubricant in a tablet product or preservative material in a liquid formulation etc.) The quantity used of the excipient for the manufacture of medicinal products Daily patient intake of the excipient Any known quality defects both globally and at a local company level related to the excipient Whether the excipient is a composite Potential impact on the Critical Quality Attributes of the medicinal product Draft Guideline from EC (SANCO/D/6/SF/mg/ddg1.d.6(2013)179263) 05. Feb IPEC Europe Excipient Forum 8
9 Determination of appropriate GMP based on Type of Excipient Having established and documented the risk profile of the excipient the Manufacturing Authorisation Holder should establish and document: The elements of EU GMP that the company believes are needed to be in place in order to control and maintain the quality of the excipient, i.e. The Rules Governing Medicinal Products in the European Union, Eudralex Volume 4, Part I, Annex 1 and Annex 2, Part II etc. Draft Guideline from EC (SANCO/D/6/SF/mg/ddg1.d.6(2013)179263) 05. Feb IPEC Europe Excipient Forum 9
10 GMP for Excipients Manufacturer and user of excipients do not need to develop their own GMP for excipients! Some examples of voluntary industry standards: IPEC-PQG GMP Guide, 2006 USP General Chapter <1078> EXCiPACT NSF/IPEC/ANSI NEW The application of these voluntary standards will in most cases be appropriate 05. Feb IPEC Europe Excipient Forum 10
11 Industry Perspective How to implement such a risk assessment? 05. Feb IPEC Europe Excipient Forum 11
12 Industry Approach to Risk Assessment A substantial contribution to a risk assessment will be needed from the excipient manufacturer IPEC Europe and PQG are working together to develop a risk assessment model for practical application by the excipient user The principles are supported by EFPIA 05. Feb IPEC Europe Excipient Forum 12
13 Model proposed Industry recognizes that ICH Q9 does not mandate one specific Quality risk assessment (QRA) tool, a number of tools are available... and allow application on all affected processes (i.e. also GMP for excipients) The industry proposed model is one approach describing the principle areas which must be considered by applying any tool to excipients GMP The model fits with existing approaches to supplier risk management such as the PQG Guide to Supply Chain Risk Management * * 05. Feb IPEC Europe Excipient Forum 13
14 Example Excipient Risk Management Process** P. Rafidison, F. Holtz, S. Rönninger, A Practical Approach of Implementing GMP for Excipients, Pharm. Tech., September, 2014, Feb IPEC Europe Excipient Forum 14
15 Risk Management Process** P. Rafidison, F. Holtz, S. Rönninger, A Practical Approach of Implementing GMP for Excipients, Pharm. Tech., September, 2014, Feb IPEC Europe Excipient Forum 15
16 Typical Quality Areas to Consider for the Risk Assessment** In the context of manufacturing of excipients, five specific areas of potential risks should be considered, understood and assessed when reviewing the excipient manufacturers quality management system, as applicable. Quality Management System (QMS) Supply chain Manufacturing of the excipient Route of administration in the drug product Function of the excipient P. Rafidison, F. Holtz, S. Rönninger, A Practical Approach of Implementing GMP for Excipients, Pharm. Tech., September, 2014, Feb IPEC Europe Excipient Forum 16
17 Hazards and Controls** P. Rafidison, F. Holtz, S. Rönninger, A Practical Approach of Implementing GMP for Excipients, Pharm. Tech., September, 2014, Feb IPEC Europe Excipient Forum 17
18 Basic GMP Elements References** P. Rafidison, F. Holtz, S. Rönninger, 05. Feb A Practical Approach of Implementing GMP for IPEC Europe Excipient Forum 18 Excipients, Pharm. Tech., September, 2014, 26-36
19 **Reference: Pharmaceutical Technology Europe September 2014 PharmTech.com, pages Feb IPEC Europe Excipient Forum 19
20 Summary The EU Falsified Medicines Directive requires to apply a risk assessment to ascertain the appropriate GMP for excipients The new EU risk assessment guideline gives general guidance Industry developed a excipient risk assessment model to: provide a simple means for the excipient user to source and confidently use excipients in their end product help the excipient user recognise and address the unique hazards and risks associated with excipients due to them being produced for a wide range of applications encourage excipient manufacturers and users to work collaboratively to mitigate risk provide a excipient specific model that fits with ICH Q9 05. Feb IPEC Europe Excipient Forum 20
21 Acknowledgements Thanks to all who supported developing the model Special thanks to: Patricia Rafidison, Dow Corning Stephan Rönninger, Amgen (Europe) GmbH 05. Feb IPEC Europe Excipient Forum 21
22 Thank you 05. Feb IPEC Europe Excipient Forum 22
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
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL VERSION 4.1
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy Brussels, SANCO/D/6/SF/mg/ddg1.d.6(2013) IMPORTATION OF ACTIVE SUBSTANCES
Copyright 2014 The International Pharmaceutical Excipients Council
The International Pharmaceutical Excipients Council Significant Change Guide for Pharmaceutical Excipients Third Revision, 2014 Copyright 2014 The International Pharmaceutical Excipients Council i The
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Ref. Ares(2013)148102-05/02/2013 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy Brussels, SANCO/D/6/SF/mg/ddg1.d.6(2013)179367
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
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
Good Manufacturing Practices: A Synopsis of Their Role and Rationale in Today's Pharmaceutical Marketplace for Tubing
Good Manufacturing Practices: A Synopsis of Their Role and Rationale in Today's Pharmaceutical Marketplace for Tubing Katherine L. Ulman and Dr. Patricia Rafidison Dow Corning Healthcare About the Authors
Guideline on dossier requirements for Type IA and IB notifications
Guideline on dossier requirements for Type IA and IB notifications In accordance with Regulation (EC) No 726/2004 and Directives 2001/83/EC and 2001/82/EC, a common approach to the procedures for variations
SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT
SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption
Quality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle
Quality Risk Management 11 November 2011 Galway, Ireland Quality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle Overview Regulatory
General Principles for the Safety Assessment of Excipients
General Principles for the Safety Assessment of Excipients General Characteristics of the Pharmaceutical Excipients Classification of excipients The Safety Assessment of Pharmaceutical Excipients : how
HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER
HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER DISCUSSION IN THE HMPWG 2003-2005 RELEASE FOR CONSULTATION December 2005 DEADLINE
Regulation and Risk Management of Combination Products
Regulation and Risk Management of Combination Products Katherine Ulman Associate Scientist Global Regulatory Compliance Manager Dow Corning Healthcare Jim Curtis Senior Specialist, Healthcare Applications
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
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
EFPIA Good Practice Revision 1, October 2014
EFPIA Good Practice Revision 1, October 2014 Reducing Risk of Drug Products Shortages Introduction Authorities, industry and healthcare providers have a responsibility to ensure a modern and sustainable
Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials. Agenda Topics for Discussion
Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS Eli Lilly & Co. Principal Consultant - Regulatory PDA/FDA Joint September 20 th, 2011
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
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
The Management of Pharmaceuticals in the Environment (PIE) FAQ. Key questions and answers. Q: How do pharmaceuticals get into the environment?
The Management of Pharmaceuticals in the Environment (PIE) FAQ Key questions and answers Q: How do pharmaceuticals get into the environment? A: Like many foods and supplements that are consumed by humans
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
NSF International Standard / American National Standard. NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
NSF International Standard / American National Standard NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients NSF International, an independent, notfor-profit, non-governmental
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.
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
Industry Implications of Pharmaceutical Quality ICH Guidelines
EIPG General Assembly Industry Implications of Pharmaceutical Quality ICH Guidelines 20 th April 2008 Pharmaceutical Quality Develop a harmonised pharmaceutical quality system applicable across the lifecycle
Expectations for Data to Support Clinical Trial Drugs
Expectations for Data to Support Clinical Trial Drugs Presentation to: APEC Advanced Workshop on Review of Drug Development in Clinical Trials Bangkok Thailand Feb 2-6 2009 Willem Stevens Ph.D., Chief
IPEC- Americas Ongoing Projects
Hold technical meetings with PDG IPEC- PDG Working On- going monograph Meet with PDG late Oct to plan on as needed basis/meet yearly group harmonization agenda for Nov meeting with PDG JECFA/Food Related
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
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
1. Consultation of the Committee (SCFCAH)
GUIDELINES FOR THE DEVELOPMENT OF COMMUNITY GUIDES TO GOOD PRACTICE FOR HYGIENE OR FOR THE APPLICATION OF THE HACCP PRINCIPLES, IN ACCORDANCE WITH ARTICLE 9 OF REGULATION (EC) NO 852/2004 ON THE HYGIENE
Guideline on Process Validation
1 2 3 4 29 March 2012 EMA/CHMP/CVMP/QWP/70278/2012-Rev1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) 5 6 Draft Draft Agreed by CHMP /
Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130
Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 12 Summary of Product Characteristics
APV/IPEC Europe Excipient Conference 2014
APV/IPEC Europe Excipient Conference 2014 An update on regulatory and application developments 23 to 24 September 2014 Düsseldorf, Germany Course No. 3128 Marketing Düsseldorf Target Group This conference
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
European Medicines Agency Inspections London, 19 May 2005 CPMP/QWP/4359/03 EMEA/CVMP/205/04 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Annex 9 Guide to good storage practices for pharmaceuticals 1
World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 9 Guide to good storage practices for pharmaceuticals 1 1. Introduction 125 2. Glossary 126 3. Personnel 128 4. Premises and facilities
GUIDELINE ON ACTIVE PHARMACEUTICAL INGREDIENT MASTER FILE (APIMF) PROCEDURE 1 (The APIMF procedure guideline does not apply to biological APIs.
15 January 2007 GUIDELINE ON ACTIVE PHARMACEUTICAL INGREDIENT MASTER FILE (APIMF) PROCEDURE 1 (The APIMF procedure guideline does not apply to biological APIs.) TABLE OF CONTENTS 1 INTRODUCTION... 2 2
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
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...
Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
Not for publication. This draft text is for circulation for approval by the Joint Committee and has not been published or otherwise officially promulgated. All rights reserved. This document may be reproduced
Annex 6. Guidance on variations to a prequalified product dossier. Preface
Annex 6 Guidance on variations to a prequalified product dossier Preface This guidance document was technically and structurally inspired by the Guideline on dossier requirements for type IA and IB notifi
ICH guideline Q8, Q9 and Q10 - questions and answers volume 4
December 2010 EMA/CHMP/ICH/265145/ Committee for medicinal products for human use (CHMP) ICH guideline Q8, Q9 and Q10 - questions and answers volume 4 Step 5 Transmission to CHMP for information December
Public Assessment Report UKPAR. Levonorgestrel 1.5 mg tablet. (levonorgestrel). UK Licence No: PL 41947/0006. ELC Group s.r.o.
Public Assessment Report UKPAR Levonorgestrel 1.5 mg tablet (levonorgestrel). UK Licence No: PL 41947/0006 ELC Group s.r.o. 1 LAY SUMMARY Levonorgestrel 1.5 mg tablet (Levonorgestrel, tablet, 1.5 mg) This
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
ICH Q9 Quality Risk Management - an industry view. Peter H. Gough, Eli Lilly and Company
ICH Q9 Quality Risk Management - an industry view Peter H. Gough, Eli Lilly and Company Contents How did we get here? FDA 21 st Century GMP Initiative ICH activity Introduction to risk management Links
Microbiology and Auditing. Don Singer
Microbiology and Auditing Don Singer ASQ Northeast Pharmaceutical GMP/Quality Conference 2011 Through the eyes of a Microbiologist Microbiology Audit = Inspection / Investigation Systematic Auditing Planning
REACH and Safety Data Sheets
This leaflet explains the requirements for safety data sheets and how they will change in the future. What is REACH? REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) is the
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON TABLET FRIABILITY GENERAL CHAPTER Q4B ANNEX 9(R1)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL
Emerging Device Topics for Regulatory Consideration.. Janine Jamieson May 2015
Emerging Device Topics for Regulatory Consideration. Janine Jamieson May 2015 Disclaimer These are my personal views and not necessarily those of MHRA as an organisation. 2 European regulation of combination
Guidance for Industry: Quality Risk Management
Guidance for Industry: Quality Risk Management Version 1.0 Drug Office Department of Health Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. What is risk?... 4 5. Integrating
Lifecycle CMC Management: ICH Q12 Progress to date
Lifecycle CMC Management: ICH Q12 Progress to date BWP/QWP/GMDP IWG Industry European workshop 28-29 October 2015 Jean-Louis ROBERT (EU) Graham Cook (EFPIA) Please take note The following slides represent
The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers.
Supplier Quality Standard 1.0 Purpose The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers. These expectations
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
Pharmaceutical Auditor Training
www.nsf.org Formerly NSF-DBA The right people. The right solution. The first time. Pharmaceutical or Training Pharmaceutical GMP s and Self-Inspections PQMS or/lead or Training Course A17638 Why Choose
Guidance for Industry
Guidance for Industry Q8, Q9, and Q10 Questions and Answers(R4) U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics
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
Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044
Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product
GS1 Healthcare Discussion paper on Mobile Applications and Services in Healthcare
Mobile Applications and Services In the last 20 years there has been a significant growth of mobile communication devices, such as mobile/cell phones, tablet computers and personal digital assistants (PDAs);
Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials
Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials Ron Hinkel, Director Quality Systems BioReliance Inc. Patti Rossman, President Globiox Purpose Keep pace
High Potent Drugs & Containment Technology
High Potent Drugs & Containment Technology Technology Overview & Quality Risk-Based Design Selection Holger Fabritz Head of Quality & Validation Assurance Part 1 Definition High Potent Drugs, OEL & hazardous
Regulatory Expectations for GMP: What s Happening. Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc.
Regulatory Expectations for GMP: What s Happening Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc. Topics Background for changes and expectations of regulatory
COMMISSION IMPLEMENTING REGULATION (EU)
L 33/2 Official Journal of the European Union 2.2.2013 REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) No 91/2013 of 31 January 2013 laying down specific conditions applicable to the import of groundnuts
1083.4 SUPPLY CHAIN INTEGRITY AND SECURITY
BRIEFING 1083.4 Supply Chain Integrity and Security. A new series of general informational chapters describing various aspects of the pharmaceutical supply chain replaces Good Distribution Practices Supply
Guide to Fees for Veterinary Products
Guide to Fees for Veterinary Products FIN-G0003-14 04 FEBRUARY 2016 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS ABBREVIATIONS
COMMISSION DIRECTIVE 2003/94/EC
L 262/22 COMMISSION DIRECTIVE 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal
Authorisation and Restriction Newsletter
Authorisation and Restriction Newsletter August 2010, N 1 The information contained in this document is intended for guidance only and whilst the information is provided in utmost good faith and has been
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY VERSION 7
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems and products Medicinal products quality, safety and efficacy Brussels, IMPORTATION OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS
IMPURITIES IN NEW DRUG PRODUCTS
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current
CLP regulation & 2015 deadline for mixtures
CLP regulation & 2015 deadline for mixtures CEFIC REACH Information and Experience Exchange Forum Zaventem, 18 December 2013 Maurits-Jan Prinz European Commission DG Enterprise & Industry Table of contents
Working with ICH Quality Guidelines - the Canadian Perspective
Working with ICH Quality Guidelines the Canadian Perspective Krishnan Tirunellai, Ph. D. Bureau of Pharmaceutical Sciences Therapeutic Products Directorate Health Canada December 3, 2008 Outline Introduction
Biotech Concerto #3. European Clinical Trial Environment
Biotech Concerto #3 European Clinical Trial Environment December 2008 Index EU Directive EU Approval System European Authority: EMEA The Guidance Documents Route Map Challenges EMEA Organization Chart
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/sl/ares(2010)1064599 EudraLex The Rules Governing Medicinal Products
Food supplements. Summary information on legislation relating to the sale of food supplements
Food supplements Summary information on legislation relating to the sale of food supplements 1 This guidance applies to the whole of the UK and was prepared by the Department of Health in association with
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.
Quality Thinking in other Industries. Dominic Parry Inspired Pharma Training. WEB www.inspiredpharma.com GMP BLOG inspiredpharmablog.
Quality Thinking in other Industries Dominic Parry Inspired Pharma Training WEB www.inspiredpharma.com GMP BLOG inspiredpharmablog.com Welcome The traditional focus on quality Quality in the eyes of GMP
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
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
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
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/an D(2010) 380358 EudraLex The Rules Governing Medicinal Products in
ICH Q10 and Change Management: Enabling Quality Improvement
ICH Q10 and Change Management: Enabling Quality Improvement Bernadette Doyle PhD Vice President and Head of Global Technical Group Global Manufacturing and Supply GlaxoSmithKline Overview Drivers for Change
Guidelines. of 16.05.2013
EUROPEAN COMMISSION Brussels, 16.05.2013 C (2013) 2804 Guidelines of 16.05.2013 on the details of the various categories of variations, on the operation of the procedures laid down in Chapters, a, I and
Qualification of Excipients for Use in Pharmaceuticals
INTERNATIONAL PHARMACEUTICAL EXCIPIENTS COUNCIL Qualification of Excipients for Use in Pharmaceuticals Copyright 2008 International Pharmaceutical Excipients Council QUALIFICATION OF EXCIPIENTS FOR USE
EudraLex. The Rules Governing Medicinal Products in the European Union Volume 4
Ref. Ares(2015)283695-23/01/2015 PT CHAPTER 5 PRODUCTION EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy EudraLex
ANASTROZOLE 1 MG FILM-COATED TABLETS. (Anastrozole) PL 40378/0123 UKPAR TABLE OF CONTENTS
ANASTROZOLE 1 MG FILM-COATED TABLETS (Anastrozole) PL 40378/0123 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product Characteristics
INFORMATION FOR OBSERVERS. Project: Compliance Costs for REACH (Agenda Paper 3)
30 Cannon Street, London EC4M 6XH, United Kingdom Tel: +44 (0)20 7246 6410 Fax: +44 (0)20 7246 6411 E-mail: iasb@iasb.org Website: www.iasb.org International Accounting Standards Board This observer note
Public Assessment Report Scientific discussion. Amitriptylin Abcur (amitriptyline hydrochloride) Asp no : 2013-0678 2013-0679 2013-0680
Public Assessment Report Scientific discussion Amitriptylin Abcur (amitriptyline hydrochloride) Asp no : 2013-0678 2013-0679 2013-0680 This module reflects the scientific discussion for the approval of
Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) Summary This document examines the key aspects of the CLP
In terms of food quality, you want to be absolutely confident that the results you get are reliable.
In terms of food quality, you want to be absolutely confident that the results you get are reliable. Welcome to the centre of excellence for food analysis Our strong core competences in food chemistry
Pharmaceutical Quality Systems: US Perspective
Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical
NATIONAL ENVIRONMENTAL EMVIRONMENTAL MANAGEMENT ACT AMENDMENT BILL: WASTE. Parliament 28 th January 2014. Dr Dhiraj Rama
NATIONAL ENVIRONMENTAL EMVIRONMENTAL MANAGEMENT ACT AMENDMENT BILL: WASTE Parliament 28 th January 2014 Dr Dhiraj Rama NATIONAL ENVIRONMENTAL MANGEMENT ACT AMENDMENT BILL: MINING CONTENTS 1. Introduction
PL 17871/0208 UKPAR TABLE OF CONTENTS
Fultium-D 3 3,200 IU Capsules PL 17871/0208 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient
REPORT FOR INTERNATIONAL COOPERATION ON COSMETIC REGULATION (ICCR)
REPORT FOR INTERNATIONAL COOPERATION ON COSMETIC REGULATION (ICCR) Principles for the handling of traces of impurities and/or contaminants in cosmetic products Report is: 1 [Choose One] Prepared For ICCR
IPEC Federation Contents Dedication Foreword Acknowledgements Individual Acknowledgements General Introduction
IPEC Federation The EXCiPACT standards in this document are copyright protected by EXCiPACT a subsidiary of the IPEC Federation. The EXCiPACT standards may not be reproduced, stored in a retrieval system
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
Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291
Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Steps Taken for Assessment Page 13 Summary of Product Characteristics
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;
DIRECTIVE 65/65/EEC Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of
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
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
COMMISSION REGULATION (EU)
L 122/22 Official Journal of the European Union 11.5.2011 COMMISSION REGULATION (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons and
FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005)
FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) Dr.R.MANAVALAN, M.Pharm., Ph.D. Professor and Research Director, Department of Pharmaceutics,