Manufacturing Cellular Products for International Clinical Trials

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Manufacturing Cellular Products for International Clinical Trials"

Transcription

1 Manufacturing Cellular Products for International Clinical Trials Q U A L I T Y A N D O P E R A T I O N S T R A C K 7 4 / 2 5 / : : 1 5 Olive J Sturtevant, MHP,MT (ASCP)SBB, CQA Director of CTQA Dana Farber Cancer Institute, Boston, Ma

2 Objectives: To provide an overview of some of considerations and challenges with multi-center / international clinical trials especially for US Academic Institutions & Manufacturing Facilities To review some challenges with the EU PICs and API regulations especially for a US Academic CT manufacturers Discuss the use of new tools to share and capture important trial information and outcome data

3 Brief Overview of Cells Manufactured by DFCI-CMCF Product Volumes and Types Stem Cell Products YEAR Proj Bone Marrow Products Apheresis Products Cord Products DLI Products Total Products Novel CT Proj Gene Therapy-HSCT 8 17 Cancer Vaccines Immunotherapy CAR-T cells 1 15 CD4Treg 5 15 TCRab/CD Viral CTL 8 other T and NK cells 4 Regenerative Med MSC 3 36 Limbal SC 4 DC 5 10 Renal 3 8 Other Other Totals

4 DFCI-CMCF Active Protocols

5 Ambiguous definitions, as identical terms may be interpreted differently from one country to another, or even within the same country. Taken from recent work on clinical research wwww.esf.org/fileadmin/links/emrc/fl_idct.pdf), Difficulties Identified By European Medical Research Councils (EMRC) Three major issues are emerging: Persisting differences in administrative processes and in the interpretation of existing regulations and other processes have led to even higher levels of complexity especially in multinational clinical trials. Today, the sponsor of a clinical trial needs to have a very detailed knowledge of every country s requirements for clinical trial authorizations from both competent authorities and ethics committees. The sponsor has to integrate different national requirements to the protocol and may need parallel submission in multinational trials.

6 Eight Major Issues Lack of knowledge of and applying legislation regulations amongst different countries Differing Ethic Committees /IRBs Lack of expertise/resources across all centers Lack of standard definition of roles and responsibilities of investigators and sponsors Payment for Insurance Standard of care Different rules for ADRx (Adverse Events) Importation of Drug Products Requirements & Compliance with GMPs for Manufacturing of Advance Therapy Medicinal Products

7 Moving Applications and Protocols through Regulatory and Review Boards FDA and EU authorities, local authorities Gene Therapy trials RAC (Recombinant DNA Activities Committee) US Academic based Scientific Review Committees, Biohazard, Institutional Review Boards, Institutional Biosafety committee, etc.

8 Multiple Sites or One? Clinical Patient screening and assessments Collections Donor screening, assessments or testing Manufacturing Processing QC testing Special release testing Treatment Administration of the products Assessment post infusion Immediate and long term follow-up Outcome data gathering

9 Qualifying Other Sites Develop Selection Criteria Site Selection & Feasibility Questionnaire (SSFQ) Send to prospective participating sites to determine if they are able to meet DF/HCC and protocol requirements. Review SSFQs by the DF/HCC Sponsor prior to extending protocol participation to an external site. A Protocol Feasibility Questionnaire(PFQ) may be used for sites that have previously participated in a Multi-Center Protocol conducted by the same disease group and have previously completed the SSFQ for their site within the past year. Prospective participating sites that have satellite sites that will also be participating in the research must complete a Satellite Feasibility Questionnaire for each satellite site.

10 Use of a Similar Questionnaire for Collection and Manufacturing Services Quality Systems Facility Master File Facility site qualifications Classified vs not classified space Equipment Personnel qualifications Accreditations requirements Manufacturing and testing ability Ability to accommodate manufacturing and testing volumes

11 Special Requirements for Testing and Manufacturing Services Ability to screen and tests donors according to local and international regulations Use of a centralized site for some tests Pathology and Genetic assessments Radiological services Similar for QC testing Centralized specialized testing, CFUs, VCN, etc. Centralize testing for product characterization, Sterility, Mycoplasma, Endotoxin

12 PICs Pharmaceutical Inspection Co-operation Scheme (Guide to GMP for Medicinal Products) 20-Sections (Annexes) Relevant sections to Cellular Therapy Manufacturing Annex 1: Manufacture of Sterile Medicinal Products Annex 2 Manufacture of Biological Medicinal Substances and Products for Human Use Annex 8: Sampling of Staring and Packaging Materials Annex 11: Computerized Systems Annex 13: Manufacture of Investigational Medicinal Products Annex 14: Manufacture of Medicinal Product Derived from Human Blood or Plasma Annex 15: Qualification and Validation Annex 18: GMP Guide for Active Pharmaceutical Ingredients Annex 19: Reference and Retention Samples Annex 20: Quality Risk Management Website:

13 Novel Cell Therapy Products Fall Under PICs GMPs

14 Annex 1: Manufacture of Sterile Medicinal Products Facility standards - Classifications Air HVAC requirements In operation classification may be demonstrated during normal operations, simulated operations or during media fills as worst-case simulation is required for this. EN ISO provides information on testing to demonstrate continued compliance with the assigned cleanliness classifications.

15 Environmental Monitoring Aseptic Processing Frequent monitoring methods such as settle plates, volumetric air and surface sampling (e.g. swabs and contact plates). Results from monitoring should be considered when reviewing batch documentation for finished product release. Surfaces and personnel should be monitored after critical operations. Additional microbiological monitoring is also required outside production operations, After validation of systems, cleaning and sanitization. Three media fills per person repeated every 6 months Recommended limits for microbiological monitoring of clean areas during operation: If alert and action limits are exceeded operating procedures should prescribe corrective action.

16 Annex 1 Manufacture of Sterile Medicinal Products Validation of aseptic processing should include a nutrient media fill Process simulation should mimic the actual manufacturing steps as closely as possible Three consecutive satisfactory simulation tests per shift and repeated at defined intervals and after any significant modifications to HVAC Normally at least twice per year per shift / process / person

17 EudraLex Rules Governing Medicinal Products in the EU Vol 4, EU Guidelines to GMP Medicinal Products for Human and Veterinary Use, Part 1, Chapter 3 Quality Management General 3.5 Preventing Unauthorized Entry Premises and Equipment Not only for manufacturing space Manufacturing Badge in and out Limited Access by room

18 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 3: Premises and Equipment 3.18 Storage of sufficient capacity to allow orderly storage of various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine released, rejected or recalled materials

19 or Use of Per Institutional SOPs or Controlled Procedures Consents and protocols Screening tools SOPs Batch Records Labels Data repositories CRF What language(s) or dialect(s) Date format (dd/mm/yyyy) Patient identifiers Name / no name Surname, Study IDs Naming convention

20 Site Master File Part III of the GMP (Good Manufacturing Practice) guidelines on the preparation of the site master file Site master File: document describing the GMP related activities of the manufacturer etail.cfm?&item_id=3944

21 Develop Clinical Protocol Specific Data and Safety Monitoring Plan (DSMP) DF/HCC Multi-Center International Data and Safety Monitoring Plan (DSMP) template. The DSMP should be tailored to the study and serves as a reference for the Participating Site(s) outlining the expectations for participating in a DF/HCC Multi-Center Protocol. DSMP as Attachment/appendix to the protocol.

22 Annex 2 - Part A. General guidance Documentation Biological starting materials Auto and Donor Matched the manufactured product is a batch Full traceability (30 years) For ATMPs, traceability requirement regarding human cells including hematopoietic cells must comply with the principles laid down in national legislation (In the EEA, these are Directives 2004/23/EC and 2006/86/EC) Research and Quality Agreements between the responsible parties should define traceability and retention periods Production -Full traceability of Biological Starting Materials

23 Production Starting Materials Raw Materials (e.g. cryoprotectants, feeder cells, reagents, culture media, buffers, serum, enzymes, cytokines, growth factors) should be clearly defined. Source, qualifications and testing, along with source documents Qualify before use Have process in place to reject CT product batch if QC testing of raw material fail Identification testing of all starting materials Compliance with the requirements appropriate to manufacturing stage Reference: Part I and Annex 8 for biological medicinal products and Part II for biological substances

24 Production Starting Materials (e) The transport of human tissues and cells to the manufacturing site must be controlled by a written agreement between the responsible parties. The manufacturing sites should have documentary evidence of adherence to the specified storage and transport conditions. (f) Continuation of traceability requirements started at tissue establishments through to the recipient(s), and vice versa, including materials in contact with the cells or tissues, should be maintained. (g) A technical agreement should be in place between the responsible parties (e.g. manufacturers, tissue establishment, Sponsors, MA Holder) which defines responsibilities of each party, including the RP.

25 Production Starting Materials for Gene Therapy (a) For products consisting of viral vectors, the starting materials are the components from which the viral vector is obtained, master virus seed or the plasmids to transfect the packaging cells and the MCB of the packaging cell line (b) For products consisting of plasmids, non-viral vectors and genetically modified micro-organisms other than viruses or viral vectors, the starting materials are the components used to generate the producing cell, the plasmid, the host bacteria and the MCB of the recombinant microbial cells (c) For genetically modified cells, the starting materials are the components used to obtain the genetically modified cells, the starting materials to manufacture the vector and the human or animal cell preparations. (d) The principles of GMP apply from the bank system used to manufacture the vector or plasmid used for gene transfer

26 Quality Control for Release Testing Process Control in place for Batch Certification or COA prior to completion of final product QC tests The procedure for batch certification and release may be carried out in stages before and after full QC analytical test results are available: Use of rapid microbiological tests may help Designated review Assessment of batch processing records, Results from environmental monitoring (where available), Deviations from normal procedures, Available analytical results Conditional certification / Sign-off by the Responsible Person.

27 Training Do you train and standardize the whole process patient selection to infusion or just in-lab manufacturing? Patient selection criteria Esoteric markers, pathology slides, radiology, etc Collection Processing Infusion Follow up care

28 Validations How to compare performance Product assessments Single QC lab for all sites vs each processing facility All tests or just esoteric test (RCR, RCL) Source material Supplies/reagents/equipment Periodic reassessments Proficiency testing

29 Same or Equivalent Supplies & Reagents Critical Supplies / Reagents / Study drug Equipment QC tests / methods CLIA approved lab Central lab or each site Flow Cytometry Gating strategies CFU assays ELISA, PCR, etc Pathology Proficiency samples

30 Challenges in Exporting Products to EU Countries Multiple and varying regulations Shipping Advance Therapy Medicinal Products Need of a broker / Competent Authority to accept ATMP Product on your behalf Need to establish a process to qualify US Academic Manufacturing Facilities as EU acceptable GMP facilities

31 Communication is Vital, yet Challenging Face to face vs WebEx Frequency Time zones Language and cultural differences Technical differences

32 Use of Centralized Documents and Clinical Research Documents SOPs, batch records, CRF Measuring performance - Dashboards e-trial Master File documents Inspection ready Audits

33 Challenges of Shared e-information Systems / Data Base Annex -11 Applications should be validated and infrastructure qualified Documented Risk Management System for both clinical and lab based systems Formal agreements with 3 rd party providers (including in-house IT departments) 21 CFR part 11 Compliance Need appropriate Risk Management Patient safety and protection of PHI Data integrity Product quality

34 Cloud Technology vs Portal system etrial Master Files Cloud allows academic centers as well as small and medium businesses with technology Working together in a collaborative space Web-base document management systems Document management, exchange and tracking across all centers and groups (CRO, investigators, sponsors, manufacturing sites, etc) Web-base data capture systems Outsource or not Overcoming IT security

35 Need for Web Based Regulatory Repository Create a common web-based repository of information about national laws and regulations for performing clinical trials. Provide a list the key information and documents; How to start, conduct a clinical trial How to report events List of key contacts and links to the Internet sites of national competent authorities.

36 International Collaborations for Novel CT Trials Continue to work together setting up and managing multi-center clinical trials is complex Academic researchers for non-commercial purposes form a substantial and critical role in medical research and there is an increasing need for Academic Centers to participate in / or run Multicenter Cell Therapy Clinical Trials Rare Diseases Personalized Medicine trials Advancement of Science This will not be possible without national or local support and it is vital to keep patients and general public actively involved to partner and push for national support for the advancement of these novel trials

Valentina Gualato, Ph.D. Process Development Scientist

Valentina Gualato, Ph.D. Process Development Scientist COMPANY PRESENTATION Quality and Innovation Valentina Gualato, Ph.D. Process Development Scientist MISSION areta international is a biotech company dedicated to the contract development and manufacturing

More information

Document Review: Centers for Medicare and Medical Service (CMS) What Do I Need to Do to Assess Personnel Competency?

Document Review: Centers for Medicare and Medical Service (CMS) What Do I Need to Do to Assess Personnel Competency? Document Review: Centers for Medicare and Medical Service (CMS) What Do I Need to Do to Assess Personnel Competency? http://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/clia_compbrochure_508.pdf

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

Quality and Safety Evaluation of Gene Therapy Products in Japan

Quality and Safety Evaluation of Gene Therapy Products in Japan Quality and Safety Evaluation of Gene Therapy Products in Japan Review Mechanism for Gene Therapy in Japan The review mechanism for gene therapy in Japan was partially amended to simplify the necessary

More information

Extemporaneously Prepared Early Phase Clinical Trial Materials

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

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

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 Health systems and products Medicinal products- authorisations, European Medicines Agency Brussels, EudraLex The Rules Governing Medicinal

More information

Combination Products. Presented by: Karen S. Ginsbury For: IFF March 2014. PCI Pharma

Combination Products. Presented by: Karen S. Ginsbury For: IFF March 2014. PCI Pharma Combination Products Presented by: Karen S. Ginsbury For: IFF March 2014 Types of products Biological and medical device (freeze dried + syringe dual volume) Medical device and plasma devised product (syringe)

More information

GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS

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

More information

GMP Inspection report

GMP Inspection report Inspected site(s): Activities Carried out: GMP Inspection report Manufacture of Active Substance Manufacture of Finished Medicinal Product Packaging Importing Laboratory Testing Batch Control and Batch

More information

Qualification of an Environmental Monitoring Program

Qualification of an Environmental Monitoring Program [ Scott Sutton Qualification of an Environmental Monitoring Program Scott Sutton Microbiology Topics discusses various topics in microbiology of practical use in validation and compliance. We intend this

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

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

Presented by Rosemarie Bell 24 April 2014

Presented by Rosemarie Bell 24 April 2014 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

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

Manufacturing process of biologics

Manufacturing process of biologics Manufacturing process of biologics K. Ho Afssaps, France 2011 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2011 ICH 1 Disclaimer:

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

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

Guidance for Industry: Starting Material Supplier Management

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

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/an D(2010) 380358 EudraLex The Rules Governing Medicinal Products in

More information

Annex 2. WHO good manufacturing practices for pharmaceutical products: main principles 1

Annex 2. WHO good manufacturing practices for pharmaceutical products: main principles 1 Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and

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

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

Good Manufacturing Practices (GMPs) More than a few Numbers!

Good Manufacturing Practices (GMPs) More than a few Numbers! Good Manufacturing Practices (GMPs) More than a few Numbers! Where Do We Find Them? Depends on what you want. Are you looking for good manufacturing practices for Blood and Blood Products Tissues (HCT/Ps)

More information

Luca Romagnoli, Ph.D. Business Development Manager

Luca Romagnoli, Ph.D. Business Development Manager Modelli innovativi di produzione per lo sviluppo di un processo altamente qualitativo di farmaci biologici Luca Romagnoli, Ph.D. Business Development Manager BIOLOGICAL DRUGS - SOURCES Monoclonal antibodies

More information

US Regulations for Import and Export of Cell Therapy Products

US Regulations for Import and Export of Cell Therapy Products US Regulations for Import and Export of Cell Therapy Products Kurt Gunter, MD U Minnesota UCB Transplants (2001-2007)* Total units: 790 Number US banks: 19 Number non-us banks: 12 % units from non-us banks:

More information

Table of Contents. FACT Quality Handbook, Second Edition. Table of Contents

Table of Contents. FACT Quality Handbook, Second Edition. Table of Contents Table of Contents INTRODUCTION... i ACKNOWLEDGEMENTS... ii 1. Quality Management Program Overview... 1 Diagram of Quality Program Elements... 9 Sample Quality Management Performance Summary: Colorado Blood

More information

LIBRARY GUIDE: Pharmaceutical GMPs

LIBRARY GUIDE: Pharmaceutical GMPs LIBRARY GUIDE: Pharmaceutical GMPs Table of Contents Overview............................................................................ 3 Courses Listed by Functional Area....................................................

More information

Understanding the European GMO legislation for gene therapy products in clinical trials

Understanding the European GMO legislation for gene therapy products in clinical trials Understanding the European GMO legislation for gene therapy products in clinical trials Jacqueline Barry Director of Regulatory Affairs Jacqueline.barry@ct.catapult.org.uk Summary Cell & Gene Therapy Catapult

More information

BIOTECHNOLOGY OPERATIONS

BIOTECHNOLOGY OPERATIONS BIOTECHNOLOGY OPERATIONS Principles and Practices Michael J. Roy TECHNISCHE INFORMATION SBIBLIOTHEK UNIVERSITATSBIBLIOTHEK HANNOVER CRC Press TaylorStFrancis Croup Boca Raton London New York CRC Press

More information

Intercompany Protocol for the execution of shared 3 rd Party Suppliers Audits

Intercompany Protocol for the execution of shared 3 rd Party Suppliers Audits for the execution of shared 3 rd Party Suppliers Audits Ref. document: AFA_INTERCOMPANY_PROT_04_01 Revision / Date: Rev.04.01 / May the 30 th 2013 Coming into operation: May the 31 st 2013 Number of pages:

More information

Annex 9 Guide to good storage practices for pharmaceuticals 1

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

More information

Diane Kadidlo MT(ASCP) SBB University of Minnesota Joanna Stanson, M.S. University of Pittsburgh

Diane Kadidlo MT(ASCP) SBB University of Minnesota Joanna Stanson, M.S. University of Pittsburgh Production Records & Documentation Diane Kadidlo MT(ASCP) SBB University of Minnesota Joanna Stanson, M.S. University of Pittsburgh Production Records This Session: Production Records Basic Elements Regulatory

More information

Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212

Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212 Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212 CDER Office of Regulatory Policy Jane Axelrad, JD CDER Office of Compliance Brenda Uratani, Ph.D. CDER ONDQA Ravindra Kasliwal, Ph.D.

More information

Recent Updates on European Requirements and what QPs are expected to do

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

More information

Comparability of Cord Blood Units

Comparability of Cord Blood Units Comparability of Cord Blood Units John D. McMannis,, Ph.D. Professor of Cancer Medicine Director, Cell Therapy Laboratory Technical Director, UT MDAnderson Cord Blood Bank Liaison Meeting, Bethesda June

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

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. 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

More information

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 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

More information

Library Guide: Pharmaceutical GMPs

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

More information

Cord Blood Banking and Biologic License Application (BLA) November 19, 2010

Cord Blood Banking and Biologic License Application (BLA) November 19, 2010 Cord Blood Banking and Biologic License Application (BLA) November 19, 2010 1 Webinar Presenters Tara Sadeghi, BS University of Texas MD Anderson Cord Blood Bank Michele Carbone, MS, CLS, MT(ASCP)SH,DLM,CQM,

More information

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Study Start-up

More information

Audit Report in the framework of the APIC Audit Programme

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

More information

Preamble to GMP Kefauver-Harris Amendments

Preamble to GMP Kefauver-Harris Amendments CGMP for Phase 1 Clinical Trials Harvey M. Arbit, PharmD, MBA, RAC, CCRP University of Minnesota Academic Health Center Director, IND/IDE Assistance Program Lead, Regulatory Knowledge and Support Clinical

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

Validation and Calibration. Definitions and Terminology

Validation and Calibration. Definitions and Terminology Validation and Calibration Definitions and Terminology ACCEPTANCE CRITERIA: The specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an

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

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

MeriCal Quality Profile

MeriCal Quality Profile January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures.

More information

ISO The Next Step in Laboratory Quality

ISO The Next Step in Laboratory Quality ISO 15189 The Next Step in Laboratory Quality Presented by: Chloe Scott, MLS(ASCP) CM, CQA(ASQ) BioQ Solutions, LLC chloe@bioqsolutions.com 2013 ASCLS Region X Spring Training Symposium Agenda History

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

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

[DOCKET NO.96N-0002] DRAFT

[DOCKET NO.96N-0002] DRAFT [DOCKET NO.96N-0002] DRAFT DRAFT DOCUMENT CONCERNING THE REGULATION OF PLACENTAL/UMBILICAL CORD BLOOD STEM CELL PRODUCTS INTENDED FOR TRANSPLANTATION OR FURTHER MANUFACTURE INTO INJECTABLE PRODUCTS DECEMBER,

More information

Non-clinical development of biologics

Non-clinical development of biologics Aurigon Life Science GmbH Non-clinical development of biologics Requirements, challenges and case studies Committed to Life. Sigrid Messemer vet. med. M4 Seminar March 10 th 2014 Aurigon - your full service

More information

PHARMACEUTICAL QUALITY SYSTEM Q10

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

More information

CMC Writing for IND Applications. David H. McKenna, Jr., M.D. University of Minnesota April 10-11, 2007 Workshop

CMC Writing for IND Applications. David H. McKenna, Jr., M.D. University of Minnesota April 10-11, 2007 Workshop CMC Writing for IND Applications David H. McKenna, Jr., M.D. University of Minnesota April 10-11, 2007 Workshop CMC Writing for IND Applications ~Outline~ What is the CMC section? Who writes the CMC section?

More information

Organization of QA cgmp compliance. BIT 230 Chapters 1 and 2 (Huxsoll)

Organization of QA cgmp compliance. BIT 230 Chapters 1 and 2 (Huxsoll) Organization of QA cgmp compliance BIT 230 Chapters 1 and 2 (Huxsoll) TQM Total Quality Management Approach a company uses day to day 7 strategies Leadership Information and analysis Strategic planning

More information

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

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

More information

"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

cgmp Challenges for Cord Blood Banks

cgmp Challenges for Cord Blood Banks cgmp Challenges for Cord Blood Banks Donna M. Regan, MT(ASCP)SBB St. Louis Cord Blood Bank @ SSM Cardinal Glennon Children s s Medical Center Cord Blood Bank processing facility challenges What does cgmp

More information

Guide to Regulatory Requirements for the Procurement of Human Tissues and Cells intended for Human Application

Guide to Regulatory Requirements for the Procurement of Human Tissues and Cells intended for Human Application Guide to Regulatory Requirements for the Procurement of Human Tissues and Cells intended for Human AUT-G0102-1 3 JANUARY 2013 This guide does not purport to be an interpretation of law and/or regulations

More information

How Long Does it Take to Manufacture Plasmid under GMP?

How Long Does it Take to Manufacture Plasmid under GMP? How Long Does it Take to Manufacture Plasmid under GMP? Manufacturing plasmid under GMP generally takes four to nine months, depending upon your project s specific requirements. You may be wondering, Why

More information

CHAPTER 7 QUALITY ASSESSMENT

CHAPTER 7 QUALITY ASSESSMENT CHAPTER 7 QUALITY ASSESSMENT Chapter 7 QUALITY ASSESSMENT 7.1 OVERVIEW OF CBB-SPECIFIC QUALITY ASSURANCE/QUALITY CONTROL PROGRAM An extensive, site-specific Quality Assurance/Quality Control (QA/QC) program

More information

Cord Blood Licensure. Session 2C: Advanced Cell Therapies April 11, 2013

Cord Blood Licensure. Session 2C: Advanced Cell Therapies April 11, 2013 Cord Blood Licensure Session 2C: Advanced Cell Therapies April 11, 2013 Objectives Describe rationale for cord blood licensure Cite licensure regulations Illustrate a case study of one program s pathway

More information

In vitro Device Regulation

In vitro Device Regulation In vitro Device Regulation Molecular Pathologists Reagent (Analyte) Manufacturers High Complexity Clinical Labs Commercial Academic in Vitro Diagnostics Manufacturers Drug Developers large & small 2 States

More information

INSPECTION OF TISSUE AND CELL PROCUREMENT AND TISSUE ESTABLISHMENTS. Operational Manual for Competent Authorities. Version 1.0

INSPECTION OF TISSUE AND CELL PROCUREMENT AND TISSUE ESTABLISHMENTS. Operational Manual for Competent Authorities. Version 1.0 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Health Law and International INSPECTION OF TISSUE AND CELL PROCUREMENT AND TISSUE ESTABLISHMENTS Operational

More information

15350 Sherman Way, Suite 350 Van Nuys, CA 91406 Phone 877-310-0717 Fax 818-251-5300 www.hemacare.com. April 17, 2015.

15350 Sherman Way, Suite 350 Van Nuys, CA 91406 Phone 877-310-0717 Fax 818-251-5300 www.hemacare.com. April 17, 2015. 15350 Sherman Way, Suite 350 Van Nuys, CA 91406 Phone 877-310-0717 Fax 818-251-5300 www.hemacare.com April 17, 2015 Dear Shareholder, We are experiencing exciting times at HemaCare. Over the course of

More information

QC Micro Webinar Series. Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution

QC Micro Webinar Series. Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution QC Micro Webinar Series Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution Rapid Testing Solutions / Lonza / 07 Jun 2011 Today s Presenters Bob Toal Segment Manager, Informatics

More information

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Risk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Presenter Marsha Stabler Hardiman Over 20 years experience in the

More information

Licensing Your Cord Blood

Licensing Your Cord Blood Licensing Your Cord Blood A Guide to Getting FDA Approval for Marketing your Public Bank s Lifesaving Product as a Prescription Drug 1.888.MEDIWARE Mediware.com Contents Introduction 1 Profits for Today,

More information

Author General Management Quality Assurance

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...

More information

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 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

More information

Roche Position on Human Stem Cells

Roche Position on Human Stem Cells Roche Position on Human Stem Cells Background Stem cells and treating diseases. Stem cells and their applications offer an enormous potential for the treatment and even the cure of diseases, along with

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

GMP Pharma BV. Netherlands

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

More information

Effective Training for Cell Therapy Laboratories. Diane Kadidlo MT(ASCP) University of Minnesota Molecular and Cellular Therapeutics Facility

Effective Training for Cell Therapy Laboratories. Diane Kadidlo MT(ASCP) University of Minnesota Molecular and Cellular Therapeutics Facility Effective Training for Cell Therapy Laboratories Diane Kadidlo MT(ASCP) University of Minnesota Molecular and Cellular Therapeutics Facility Training Personnel Biggest resource of an organization Reflect

More information

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN Document CEN TC 258/WG2 N15 (Draft # 6, June 2000) CEN TC 258 Committee Enquiry/ISO TC 194 Committee Draft EN ISO 14155 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS PART 2: CLINICAL INVESTIGATION

More information

PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS

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

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

The Quality System for Drugs in Germany

The Quality System for Drugs in Germany 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

More information

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,

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

Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC

Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC ISCT Conference, New Zealand, April 2013 April 1 st 2013 NIBSC will become part of the Medicines and

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

Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commercial Manufacturing

Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commercial Manufacturing Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commercial Manufacturing By Mark Zemler W H I T E P A P E R Executive Summary In support of our customers, this whitepaper

More information

Guideline on good pharmacovigilance practices (GVP)

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

More information

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 *

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 * PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PS/INF 11/2015 1 April 2015 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 * * Entry into force:

More information

Guide to Master Formulae WHO/FWC/IVB/QSS/VQR

Guide to Master Formulae WHO/FWC/IVB/QSS/VQR WHO/FWC/IVB/QSS/VQR 2011 This guidance document GUIDE TO MASTER FORMULAE is one of a series developed by WHO/FWC/IVB Quality, Safety & Standards team upon request from the manufacturers members of the

More information

Particle Monitoring in Pharmaceutical Cleanrooms

Particle Monitoring in Pharmaceutical Cleanrooms A p p l i c a t i o n N o t e Particle Monitoring in Pharmaceutical Cleanrooms Particle Monitoring in Pharmaceutical Cleanrooms by Morgan Polen, VP of Application Technology, Environmental monitoring is

More information

Guidance for Industry. Q10 Pharmaceutical Quality System

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

More information

Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations

Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

More information

BASIC CONCEPTS IN QUALITY MANAGEMENT

BASIC CONCEPTS IN QUALITY MANAGEMENT BASIC CONCEPTS IN QUALITY MANAGEMENT Ivana Ferrero Processing inspector Inspection Report Assessor Stem Cell Transplantation and Cellular Therapy Unit City of Health and Science of Turin - Italy #EBMT2015

More information

The FDA recently announced a significant

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

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

Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles

Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles Introduction 37 General considerations 39 Glossary

More information

Welcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014

Welcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014 Welcome Computer System Validation Training Delivered to FDA ISPE Boston Area Chapter February 20, 2014 1 Background Training Conducted on April 24, 2012 Food & Drug Administration Division of Manufacturing

More information

Guidance for Industry

Guidance for Industry Guidance for Industry CGMP for Phase 1 Investigational Drugs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics

More information

18.H Questionnaire for preparing GMP-inspections

18.H Questionnaire for preparing GMP-inspections Questionnaire for preparing GMP-inspections Questionnaire for preparing GMP-inspections Dr. Christine Oechslein, Max Lazar, Thomas Halfmann Here you will find answers to the following questions: What questions

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

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

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

More information