Presented by Rosemarie Bell 24 April 2014

Size: px
Start display at page:

Download "Presented by Rosemarie Bell 24 April 2014"

Transcription

1 Global Good Manufacturing Practice A Comparability Study to Link Good Manufacturing Practice Standards for World Wide Compliance Within the Cellular Therapy Industry Presented by Rosemarie Bell 24 April 2014

2 Overview Importance of GMP Standards Studied Standard Comparisons Common Points Main Differences Stumbling Points Other Considerations Wish List QIMR Berghofer Medical Research Institute 2

3 Importance of GMP

4 In a nutshell. Safety to Patient Safety of Product Consistency Continuous Improvement QIMR Berghofer Medical Research Institute 4

5 Different Standards Reviewed QIMR Berghofer Medical Research Institute 5

6 Different Standards Standards/ Codes/ Guidelines Reviewed So Far Pic/s Guide to GMP Australian Code of Good Manufacturing Practice- Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Trials Therapeutic Goods Administration (TGA) Australian Regulatory Guidelines for Biologicals (TGA) Unapproved Therapeutic Goods TGA In Vitro Diagnostic Medical Devices TGA Standards/ Codes/ Guidelines under Review Ongoing International Conference on Harmonization Guidelines (ICH) European Medicines Agency (EMEA) Guidelines Committee for Proprietary Medicinal Product (CPMP) Federal Drug Administration (FDA) Guidelines Clinical Trial Handbook TGA References ICH Guidelines EMEA Guidelines QIMR Berghofer Medical Research Institute 6

7 Results

8 LEGEND # Standard QMS Applied ** Based on Annex 13 of the PIC/S Required X Not Required * Optional QIMR Berghofer Medical Research Institute 8

9 Requirement Organisational Structure Management Review Documentation Change Control Document Control Document Storage and Retention/ Confidentiality Good Manufacturing Practice Standards Comparison Performed to Date PIC/S Guide to Good Manufacturing Practice Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Clinical Trial Handbook/ GCP Guidance /ICH /EMEA Guidelines Standard Australian Regulatory Guidelines for Biologicals Unapproved Therapeutic Goods - TGA In Vitro Diagnostic Medical Devices Quality System Requirements Written accounts of Clinical Trial Products required Written accounts of Clinical Trial Products required # (STD QMS applied) Protocol Protocol # Amendment Amendment # # QIMR Berghofer Medical Research Institute 9

10 Requirement Good Manufacturing Practice Standards Comparison Performed to Date PIC/S Guide to Good Manufacturing Practice Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Clinical Trial Handbook/ GCP Guidance /ICH /EMEA Guidelines Standard Australian Regulatory Guidelines for Biologicals Unapproved Therapeutic Goods - TGA In Vitro Diagnostic Medical Devices Monitoring Systems Internal Auditable Auditable # Audits Corrective # Actions Customer ** ** # Complaints Annex 13 PICS Recall ** ** # Security # Computer Records # QIMR Berghofer Medical Research Institute 10

11 Requirement Good Manufacturing Practice Standards Comparison Performed to Date PIC/S Guide to Good Manufacturing Practice Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Clinical Trial Handbook/ GCP Guidance /ICH /EMEA Guidelines Standard Australian Regulatory Guidelines for Biologicals Unapproved Therapeutic Goods - TGA In Vitro Diagnostic Medical Devices Personnel and Training Training # Records Donor Records # Informed Consent # Collection Records # Retrieval Records # Processing # Records Final Product # Storage/Retention and Archiving # QIMR Berghofer Medical Research Institute 11

12 Requirement PIC/S Guide to Good Manufacturing Practice Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Clinical Trial Handbook/ GCP Guidance /ICH /EMEA Guidelines Standard Australian Regulatory Guidelines for Biologicals Unapproved Therapeutic Goods - TGA In Vitro Diagnostic Medical Devices Buildings and Facilities Environmental ** ** # Control Floors, Walls and ** ** # Ceilings Cleaning ** ** # Goods Receipt ** ** # Storage Areas ** ** # Manufacturing ** ** # Areas Donor Areas ** ** # Despatch ** ** # QIMR Berghofer Medical Research Institute 12

13 Requirement Qualification and Validation Preventative Maintenance Calibration and Validation Refrigeration Equipment Cleaning of Equipment Good Manufacturing Practice Standards Comparison Performed to Date PIC/S Guide to Good Manufacturing Practice Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Clinical Trial Handbook/ GCP Guidance /with reference to ICH /EMEA Guidelines Equipment Not specifically mentioned put falls under GMP principles statement outlined in Annex 13 of the PIC/S Standard Australian Regulatory Guidelines for Biologicals Unapproved Therapeutic Goods - TGA Not specifically mentioned put falls under GMP principles statement in Annex 13 of the PIC/S In Vitro Diagnostic Medical Devices # # # # QIMR Berghofer Medical Research Institute 13

14 Requirement Good Manufacturing Practice Standards Comparison Performed to Date PIC/S Guide to Good Manufacturing Practice Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Clinical Trial Handbook/ GCP Guidance /ICH /EMEA Guidelines Standard Australian Regulatory Guidelines for Biologicals Unapproved Therapeutic Goods - TGA In Vitro Diagnostic Medical Devices Control of Material Suppliers # Contractors Contract Contract # research organisations research organisations Reagents # Collection collection # Packs kits Labels ** ** # In process # and critical material Non conforming Material # QIMR Berghofer Medical Research Institute 14

15 Requirement Good Manufacturing Practice Standards Comparison Performed to Date Standard PIC/S Guide to Australian Good Regulatory Manufacturing Guidelines for Practice Biologicals Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Clinical Trial Handbook/ GCP Guidance /ICH /EMEA Guidelines Unapproved Therapeutic Goods - TGA In Vitro Diagnostic Medical Devices Donor Selection, Donation and Testing Pre Donation Select Select # donors on suitability donors on suitability Donation # Post Donation # Testing of Donor Samples Not specifically mentioned Not specifically mentioned # Medical Director involvement Process Control Validation Based on GMP principles of the PIC/S Not specifically mentioned Based on GMP principles of the PIC/S Monitoring # Release # QIMR Berghofer Medical Research Institute 15

16 Requirement Good Manufacturing Practice Standards Comparison Performed to Date Standard PIC/S Guide to Australian Unapproved Good Regulatory Therapeutic Manufacturing Guidelines for Goods - TGA Practice Biologicals Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Clinical Trial Handbook/ GCP Guidance /ICH /EMEA Guidelines In Vitro Diagnostic Medical Devices Storage Labelling # Quarantine Not specifically mentioned Not specifically mentioned # Discard Not specifically mentioned Not specifically mentioned Packaging Labelling # Records # # QIMR Berghofer Medical Research Institute 16

17 Requirement Transport Procedure Release Procedures Adverse Events Procedures HREC Committee Master Files PIC/S Guide to Good Manufacturing Practice Good Manufacturing Practice Standards Comparison Performed to Date Standard Australian Code of Clinical Trial Australian GMP for Blood, Handbook/ GCP Regulatory Tissues and Human Guidance /ICH Guidelines for CTPs (TGA) /EMEA Guidelines Biologicals Unapproved Therapeutic Goods - TGA In Vitro Diagnostic Medical Devices Transport # Release Documentation Release criteria Documentation # requirements required as well requirements and PIC/S Annex and PIC/S Annex # Site Master File Technical Master File Other Considerations Trial Master File Technical Master File under GMP Trial Master File TMF as part of QMS STD the detail is determined by the Class of IVD. Not mentioned QIMR Berghofer Medical Research Institute 17

18 Requirement Investigator Brochure Deviation from Statistical Plan Reference to other Codes / Standards Good Manufacturing Practice Standards Comparison Performed to Date PIC/S Guide to Good Manufacturing Practice Australian Code of GMP for Blood, Tissues and Human CTPs (TGA) Council of Europe Guidelines for the Selection of Donors Clinical Trial Handbook/ GCP Guidance /ICH /EMEA Guidelines Standard Australian Regulatory Guidelines for Biologicals Unapproved Therapeutic Goods - TGA In Vitro Diagnostic Medical Devices Other Considerations x X Exempt if not x included on x ARTG under CTN, CTX scheme x X X x x Reference to ISO, ICH, EMEA Annex 13 of Stds PIC/s CPMP/ICH/1 35/95 OSP 14155, Reference to Annex 13 of the PIC/S Therapeutic Goods Act 1989, Therapeutic Goods (Medical Devices) Regulations 2002 ISO ISO Designed to reflect the PIC/S QIMR Berghofer Medical Research Institute 18

19 Requirement Other Considerations PIC/S Guide to Good Manufacturing Practice Good Manufacturing Practice Standards Comparison Performed to Date Standard Australian Code Clinical Trial Australian of GMP for Blood, Handbook/ GCP Regulatory Tissues and Guidance /ICH Guidelines for Human CTPs /EMEA Guidelines Biologicals (TGA) Other Considerations CTN / CTX scheme allows non ARTG registered goods to be supplied to the public as part of Clinical Trial. Refers to CTN and CTX Schemes for Clinical Trials Generally based on a risk management approach Specific criteria for products fall under this Code Covers Infectious Disease screening in more detail Covers donor evaluation in more detail. Unapproved Therapeutic Goods - TGA CTN/CTX scheme allows non ARTG registered goods to be supplied to the public as part of a Clinical Trial Special Access Schemes In Vitro Diagnostic Medical Devices IVD Medical Devices are classified as Class 1,2,3,4 pending on the health risk to the public. Conformity Assessment includes a QMS and design, manufacturing, risk analysis, clinical evidence and ongoing monitoring documentation. QIMR Berghofer Medical Research Institute 19

20 Still Going With FDA Guidelines EMEA Guidelines ICH Guidelines Plus other guidelines The list is endless QIMR Berghofer Medical Research Institute 20

21 Common Points

22 Established Quality Management System Traceability Emphasis on patient and product safety BUT Can be open to interpretation QIMR Berghofer Medical Research Institute 22

23 Main Differences

24 Dependant on product type or clinical trial phase. Infectious Disease Screening Requirements (IDS either side of collection/ 180 day follow up for HBV, NAT ) Process Validation Requirements Risk Management QIMR Berghofer Medical Research Institute 24

25 Stumbling Blocks

26 Requirements to conduct Clinical Trials from Phase I differ between countries Release criteria may be different IDS may need to be performed by licensed Laboratories (i.e. TGA licensed) Validation of process prior to commencement of manufacture differs between manufactured product and clinical trial QIMR Berghofer Medical Research Institute 26

27 Obtaining sponsorship to manufacture Time taken to implement Standard and acquire licence - at least 1-2 years Cost factor- can be prohibitive starts at $100k + QIMR Berghofer Medical Research Institute 27

28 Other Considerations

29 Risk Management Perception of risk may differ between groups Access to unapproved biologics different requirements/legislations between countries QIMR Berghofer Medical Research Institute 29

30 Wish List

31 To achieve a global harmonization standard that is easy to understand, easy to follow, providing a progressive approach to achieving GMP compliance, while allowing room for continuous improvement. Recognition for Companies licensed by equivalent Standards. QIMR Berghofer Medical Research Institute 31

32 While there are differences between the Standards, GMP Standards are similar and a robust global Standard harmonisation is achievable if all have one common goal product safely produced in accordance with standardised good manufacturing practice. QIMR Berghofer Medical Research Institute 32

33 Thank you

Investigator Responsibilities

Investigator Responsibilities Investigator Responsibilities Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 010 Version number: 1 Effective date: 01 June 2010 Review due: May 2011

More information

History and Principles of Good Clinical Practice

History and Principles of Good Clinical Practice History and Principles of Good Clinical Practice Cristina E. Torres, Ph.D. Social Science Professor, UPM-NIH FERCAP Coordinator ICH: International Conference on Harmonization GCP: Good Clinical Practices

More information

Pre-market Information - Class III and IV

Pre-market Information - Class III and IV Pre-market Information - Class III and IV Life Sciences Council British Columbia NRC Industry Research Assistance Program Vancouver, October 29, 2007 Mary-Jane Bell, Ph.D. Medical Devices Bureau (MDB)

More information

The Study Site Master File and Essential Documents

The Study Site Master File and Essential Documents The Study Site Master File and Essential Documents Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 002 Version number: 1 Effective date: 01 June 2010

More information

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare

More information

Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE

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

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

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

Overview of FDA Compliance for Medical Devices

Overview of FDA Compliance for Medical Devices Glisland Training Series: Overview of FDA Compliance for Medical Devices Glisland, Inc. San Jose, California, USA http://www.glisland.com Description This course provides a concise overview of how FDA

More information

Health Canada s GCP Compliance Program Part 2. GCP Information Sessions November 2010

Health Canada s GCP Compliance Program Part 2. GCP Information Sessions November 2010 Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program Part 2 GCP Information Sessions November 2010 Inspection Program Main objectives

More information

Site Initiation and Close Out (Sponsored Clinical Trials)

Site Initiation and Close Out (Sponsored Clinical Trials) Site Initiation and Close Out (Sponsored Clinical Trials) Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 008 Version number: 1 Effective date: 01 June

More information

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

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

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

Clinical Trials - Insurance and Indemnity

Clinical Trials - Insurance and Indemnity Policy Directive Clinical Trials - Insurance and Indemnity Document Number PD2011_006 Publication date 25-Jan-2011 Functional Sub group Corporate Administration - Governance Clinical/ Patient Services

More information

Quality Agreement Template

Quality Agreement Template Quality Agreement Template Prepared by Dan O Leary Ombu Enterprises, LLC 3 Forest Ave. Swanzey, NH 03446 603-209-0600 This document is intended to form the basis for a Supplier Agreement. The document

More information

Good Clinical Laboratory Practice (GCLP) An international quality system for laboratories which undertake the analysis of samples from clinical trials

Good Clinical Laboratory Practice (GCLP) An international quality system for laboratories which undertake the analysis of samples from clinical trials Good Clinical Laboratory Practice (GCLP) An international quality system for laboratories which undertake the analysis of samples from clinical trials Vanessa Grant and Tim Stiles VERSION 2 Published by

More information

Med-Info Regular Information Bulletins for the Medical Device Industry

Med-Info Regular Information Bulletins for the Medical Device Industry Med-Info Regular Information Bulletins for the Medical Device Industry Product Service Globalization of Medical Device Approval Mutual Recognition Agreements (MRA) between the EU and the USA and Australia

More information

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 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

More information

GUIDELINES ON MEDICAL DEVICES. IVD GUIDANCES : Borderline issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

GUIDELINES ON MEDICAL DEVICES. IVD GUIDANCES : Borderline issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Pressure equipment, medical devices, metrology MEDDEV. 2.14/1 rev. 1 January

More information

Good Clinical Practice 101: An Introduction

Good Clinical Practice 101: An Introduction Good Clinical Practice 101: An Introduction Presented by: Lester Jao Lacorte, MD Medical Officer Commissioner s Fellow Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological

More information

The Australian Clinical Trial Handbook

The Australian Clinical Trial Handbook The Australian Clinical Trial Handbook A simple, practical guide to the conduct of clinical trials to International standards of Good Clinical Practice (GCP) in the Australian context About the Therapeutic

More information

Diagnostic Tests. Brad Spring Director, Regulatory Affairs

Diagnostic Tests. Brad Spring Director, Regulatory Affairs Regulatory Challenges in the Development of Diagnostic Tests Industry Perspective Brad Spring Director, Regulatory Affairs September 28, 2011 Balancing Evidence of Safety & Effectiveness and Time to Market

More information

TRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP

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

More information

Conformity assessment certification

Conformity assessment certification TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA

More information

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address: NOTE TO USERS This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a

More information

Health Canada s GCP Compliance Program. GCP Information Sessions November 2010

Health Canada s GCP Compliance Program. GCP Information Sessions November 2010 Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010 Objective To describe the role that Health

More information

NABL NATIONAL ACCREDITATION

NABL NATIONAL ACCREDITATION NABL 160 NABL NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES GUIDE for PREPARING A QUALITY MANUAL ISSUE NO. : 05 AMENDMENT NO : 00 ISSUE DATE: 27.06.2012 AMENDMENT DATE: -- Amendment

More information

UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES

UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES A WHITE PAPER ON THE REQUIREMENTS, REGULATIONS AND OPPORTUNITIES CONTAINED IN EC DIRECTIVE 98/79/EC AND A BRIEF COMPARISON

More information

Archiving of Research Documentation

Archiving of Research Documentation Suspension, Termination & Completion Standard Operating Procedure VERSION / REVISION: 2.0 EFFECTIVE DATE: 28 05 12 REVIEW DATE: 28 05 14 AUTHOR(S): CONTROLLER: APPROVED BY: Clinical Trials Manager; Recruitment

More information

Medical Device Quality Agreement Template

Medical Device Quality Agreement Template Medical Device Quality Agreement Template Prepared by Dan O Leary Ombu Enterprises, LLC 3 Forest Ave. Swanzey, NH 03446 603-209-0600 This document is intended to form the basis for a Supplier Agreement

More information

gsop-32-02 - Vendor Assessment SOP page 1 of 10

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

More information

Regulation and Risk Management of Combination Products

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

More information

CONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator

CONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator Research Department STANDARD OPERATING PROCEDURE STH Investigator Archiving of Essential Documentation Generated During Clinical Research SOP Number A127 Version Number V1.3 Effective Date Author Zoe Whiteley

More information

GCP INSPECTORS WORKING GROUP REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS

GCP INSPECTORS WORKING GROUP <DRAFT> REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS European Medicines Agency London, 17 October 2007 Doc. Ref. EMEA/505620/2007 GCP INSPECTORS WORKING GROUP REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS

More information

Guidance to Research Ethics Committees on Initial Facility Assessment

Guidance to Research Ethics Committees on Initial Facility Assessment Guidance to Research Ethics Committees on Initial Facility Assessment Introduction One of the roles of a Research Ethics Committee is to provide an opinion on a proposed study, based on the suitability

More information

Clinical Trial Logistics

Clinical Trial Logistics Company Brochure Clinical Trial Logistics contents 1. 2. 3. 4. 5. 6. About us Values Facility Quality Management System Services Why PCS Clinical Trial Logistics about us MEET US PHARMA COMPLEX SOLUTIONS

More information

Design, Operation and Management of GTP/GMP Cell Engineering Facilities

Design, Operation and Management of GTP/GMP Cell Engineering Facilities Design, Operation and Management of GTP/GMP Cell Engineering Facilities Scott R. Burger, MD Advanced Cell & Gene Therapy BFDA 2007 International Symposium on Regulation of Human Cell and Tissue- Based

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

IMP management at site. Dmitry Semenyuta

IMP management at site. Dmitry Semenyuta IMP management at site Dmitry Semenyuta TOP 5 FDA inspections finding 1999-2009 Center of Drug Evaluation and Research (CDER) Failure to follow the protocol Failure to keep adequate and accurate records

More information

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process

More information

Archiving Study Documents

Archiving Study Documents This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document

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

GOOD CLINICAL LABORATORY PRACTICE (GCLP)

GOOD CLINICAL LABORATORY PRACTICE (GCLP) Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by U N I C E F / U N D P / W o r l d B a n k / W H O GOOD CLINICAL LABORATORY PRACTICE (GCLP) Special Programme for Research

More information

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION

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

More information

Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device

Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device List of Contents Page 1. Introduction 1.1 The Medical Device Administrative Control System and the 3 proposed legislation

More information

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS

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:

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

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) 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

More information

RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS

RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS 1. Overview IRB approval and participant informed consent are required to collect biological specimens for research purposes. Similarly, IRB approval

More information

How to implement a Quality Management System

How to implement a Quality Management System How to implement a Quality Management System This whitepaper will help you to implement a Quality Management System (QMS), based on Good Manufacturing Practice (GMP), ISO 9001 or ISO 13485 within your

More information

Safeguarding public health The Regulation of Software as a Medical Device

Safeguarding public health The Regulation of Software as a Medical Device Safeguarding public health The Regulation of Software as a Medical Device Dr Head of New and Emerging Technologies Medicines and Healthcare Products Regulatory Agency (MHRA) Crown Copyright 2013 About

More information

Pharmaceutical Wholesaler Site Inspection Checklist

Pharmaceutical Wholesaler Site Inspection Checklist Pharmaceutical Wholesaler Site Inspection Checklist Date and time of inspection: Legal business name and plant name: Location (address): Phone number: Fax number: Email address: Web site URL: Contact Person:

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

Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205. www.schweppesaustralia.com.au

Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205. www.schweppesaustralia.com.au Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205 www.schweppesaustralia.com.au Quality Management Systems 1. Quality Management Systems develop, implement, verify

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

Importing pharmaceutical products to China

Importing pharmaceutical products to China Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval

More information

SMF Awareness Seminar 2014

SMF Awareness Seminar 2014 SMF Awareness Seminar 2014 Clinical Evaluation for In Vitro Diagnostic Medical Devices Dr Jiang Naxin Health Sciences Authority Medical Device Branch 1 In vitro diagnostic product means Definition of IVD

More information

NABL accreditation is a formal recognition of the technical competence of a medical testing laboratory

NABL accreditation is a formal recognition of the technical competence of a medical testing laboratory NABL accreditation is a formal recognition of the technical competence of a medical testing laboratory Third party assessment NABL has Mutual Recognition Arrangement with APLAC and ILAC NABL accredited

More information

SCIENTIFIC SUBSTANTIATION OF STANDARD OPERATIONAL PROCEDURES ROLE IN QUALITY ASSURANCE SYSTEM IN CLINICAL DRUG TRIALS

SCIENTIFIC SUBSTANTIATION OF STANDARD OPERATIONAL PROCEDURES ROLE IN QUALITY ASSURANCE SYSTEM IN CLINICAL DRUG TRIALS UDC 615:519.076 Dobrova V. Ye., Zupanets K. O., Ratushna K. L. National University of Pharmacy SCIENTIFIC SUBSTANTIATION OF STANDARD OPERATIONAL PROCEDURES ROLE IN QUALITY ASSURANCE SYSTEM IN CLINICAL

More information

Harmonizing Change Control Processes Globally

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

More information

Blood Biobanking Chances and Risks. The Bavarian Red Cross Blood Donor Biobank

Blood Biobanking Chances and Risks. The Bavarian Red Cross Blood Donor Biobank Blood Biobanking Chances and Risks The Bavarian Red Cross Blood Donor Biobank EORTC-NCI-ASCO Meeting - November 2007 Outline Types of biobanking Why blood biobanking? Why blood banks? Why the Bavarian

More information

PI Name: PI Address: PI Phone No: Contracts Contacts: Contact Name: address: Phone Number:

PI Name: PI  Address: PI Phone No: Contracts Contacts: Contact Name:  address: Phone Number: A robust feasibility is an essential part of ensuring study delivery. Please pass this Study Feasibility Assessment and a copy of the Protocol to the individual(s) who are most appropriate to accurately

More information

Clinical Research in Mauritius

Clinical Research in Mauritius BOARD OF INVESTMENT Clinical Research in Mauritius This document provides an informative summary of the procedure to apply for a clinical research protocol in Mauritius. Contents INTRODUCTION... 2 I. APPLICATION

More information

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL Page 1 of 10 Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL SOP ID Number: Effective Date:01/08/2012 Version Number & Date of Authorisation: V02,

More information

2002 No. 618 CONSUMER PROTECTION. The Medical Devices Regulations 2002

2002 No. 618 CONSUMER PROTECTION. The Medical Devices Regulations 2002 STATUTORY INSTRUMENTS 2002 No. 618 CONSUMER PROTECTION The Medical Devices Regulations 2002 Made - - - - - 20th May 2002 Laid before Parliament 21st May 2002 Coming into force - - 13th June 2002 ARRANGEMENT

More information

Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes.

Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes. Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes.. www.pharmout.net Page 1 of 15 Version-02 1. Scope 1.1. Purpose This paper reviews the implementation of the ANSI/AAMI/IEC

More information

AUSTRALIAN REGULATORY GUIDELINES FOR MEDICAL DEVICES

AUSTRALIAN REGULATORY GUIDELINES FOR MEDICAL DEVICES AUSTRALIAN REGULATORY GUIDELINES FOR MEDICAL DEVICES Version 1.0 April 2010 Version history Version Description of change Author Effective Date 1.0 Initial publication on TGA website ODBT 28 April 2010

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

OECD Recommendation on the Governance of Clinical Trials

OECD Recommendation on the Governance of Clinical Trials OECD Recommendation on the Governance of Clinical Trials Marketing authorisation status of the medicinal products Non-authorised medicine Authorised medicine, treatment regimen outside

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

In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them

In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them IRB Education Conference, Columbia University April 2007 Sally Hojvat, Ph.D. Director of Microbiology Devices

More information

Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation

Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation Presentation to the American Association of Tissue Banks Savannah, Georgia March 2008 Health Canada Update Marianne

More information

Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

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

More information

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union

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)1064587 EudraLex The Rules Governing Medicinal Products

More information

STANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders

STANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders STANDARD OPERATING PROCEDURE FOR RESEARCH Management of Essential Documents and Trial Folders Author Linda Ward Author s Job Title QA Coordinator Division Department Version number 2 Ref SOP/CLN/001/2

More information

Essential Documentation and the Creation and Maintenance of Trial Master Files

Essential Documentation and the Creation and Maintenance of Trial Master Files This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document

More information

Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702

Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 9.1 Status : APPROVED Effective: 12/11/2014 Page 2 of 23 Quality Manual Table of Contents

More information

Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702

Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 9.2 Status : APPROVED Effective: 9/25/2015 Page 2 of 23 Quality Manual Table of Contents

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

TRIAL MASTER FILE- SPONSORED

TRIAL MASTER FILE- SPONSORED gsop-06-04 - Management of TMF for ENHT/ WHHT Sponsored CTIMPs Page 1 of 16 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust TRIAL MASTER

More information

Annex 7 Guidelines for the preparation of a contract research organization master file

Annex 7 Guidelines for the preparation of a contract research organization master file World Health Organization WHO Technical Report Series, No. 957, 2010 Annex 7 Guidelines for the preparation of a contract research organization master file Background 1. General information 2. Quality

More information

"Act" means the National Health Act, 2003 (Act No 61of 2003);

Act means the National Health Act, 2003 (Act No 61of 2003); 142 No.35099 GOVERNMENT GAZETTE, 2 MARCH 2012 No. R. 183 2 March 2012 NATIONAL HEALTH ACT, 2003 REGULATIONS'RELATING TO STEM CELL BANKS The Minister of Health has, in terms of section 68 of the Health

More information

Auditing as a Component of a Pharmaceutical Quality System

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

More information

IQPP Quality Assurance Standard

IQPP Quality Assurance Standard IQPP Quality Assurance Standard Background The is part of a series of standards that comprise the Plasma Protein Therapeutics Association (PPTA) IQPP Standards Program. PPTA's Voluntary Standards Program

More information

5th Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. Summary of Changes

5th Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. Summary of Changes 5th Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration Summary of Changes This document summarizes the changes made to the 5th edition of the

More information

2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials

2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials L1 2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager,

More information

The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations

The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations Maria Luisa Paoloni OPBG Clinical & Research Services Monitoring and Responsible of monitoring:

More information

Clinical Research Nurse (CRN)

Clinical Research Nurse (CRN) 1 JOB IDENTIFICATION Job title: Responsible to: Department: Division/directorate: Job reference no.: No. of CRNs: Last update: (CRN) Senior Research Nurse Consultant/ Unit Manager /PI Add local specifications

More information

Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs

Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs Charlesworth Rae, BS, PharmD, JD Investigational Drug Pharmacist July 2012 1 Outline of Presentation I. Introduction

More information

ICH Q10 Pharmaceutical Quality System (PQS)

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

More information

Public Cord Blood Bank

Public Cord Blood Bank The The Public Cord Blood Bank Page 1 of 21 TABLE OF CONTENTS INTRODUCTION... 3 WHAT ARE GOOD MANUFACTURING PRACTICES?... 5 1 TOTAL QUALITY... 7 2 PREMISES... 8 3 EQUIPMENT AND MATERIAL... 9 4 PERSONNEL...

More information

Health Products and Food Branch. www.hc-sc.gc.ca

Health Products and Food Branch. www.hc-sc.gc.ca Health Products and Food Branch 1 HEALTH CANADA PART C DIVISION 5 - DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS Part C - Division 5 2 Part A: Part B: Part C: Part D: Part E: Part G: Part J: Administration

More information

The Regulation of Medical Device Apps

The Regulation of Medical Device Apps The Regulation of Medical Device Apps Prepared for West of England Academic Health Science Network and University of Bristol June 2014 June 2014 1 Table of Contents 1 Purpose...3 2 Scope...3 3 The Regulation

More information

Clinical Trials and Safety Surveillance of Drugs in Development

Clinical Trials and Safety Surveillance of Drugs in Development Clinical Trials and Safety Surveillance of Drugs in Development Hoda Eid, M.Sc., Ph.D. Manager, ADR Unit Office of Clinical Trials Therapeutic Products Directorate hoda_eid@hc-sc.gc.ca Overview Clinical

More information

Clinical evaluation Latest development in expectations EU and USA

Clinical evaluation Latest development in expectations EU and USA Clinical evaluation Latest development in expectations EU and USA Medical Devices: staying ahead of regulatory developments Gert Bos BSI Israel 22 April - Herzliya Copyright 2012 BSI. All rights reserved.

More information

An Overview of Clinical Archiving. Russell Joyce Records & Information Manager

An Overview of Clinical Archiving. Russell Joyce Records & Information Manager An Overview of Clinical Archiving Russell Joyce Records & Information Manager Objectives To understand the Historical context of archiving Importance of archiving Regulatory & legal frameworks Archiving

More information

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL EUROPEAN COMMISSION TERPRISE AND INDUSTRY DIRECTORATE-GERAL Consumer goods Pharmaceuticals Brussels, 03/12/2009 TR/F/2/SF/dn D(2009) 35810 Detailed guidelines on good clinical practice specific to advanced

More information

Supplier Quality Assurance

Supplier Quality Assurance Supplier Quality Assurance Preface We strive to continually improve our process performance by meeting quality objectives. It is imperative that our suppliers operate under the zero defects and 100% on

More information

RAPS ONLINE UNIVERSITY

RAPS ONLINE UNIVERSITY RAPS ONLINE UNIVERSITY Practical education and training for business success. For regulatory professionals, there is only one name to know and trust for online education and training RAPS Online University.

More information