Regulatory Schema for Blood Transfusion Microbiotal transplant conference
|
|
- Wilfrid Wilkins
- 6 years ago
- Views:
Transcription
1 Regulatory Schema for Blood Transfusion Microbiotal transplant conference Baltimore, 3-4 December 2015 John R. Hess, MD, MPH, FACP, FAAAS Professor of Laboratory Medicine Medical Director, Transfusion Service Harborview Medical Center U. of Washington School of Medicine, Seattle Special Advisor to Director General, Blood Safety, 2003 WHO Expert Panel, Blood Transfusion Medicine,
2 The safest blood is Collected from the safest members of the population Tested for infectious diseases of risk Stored and transported in a safe manner Given to the right patient For the right reason WHO Global Program for Blood Safety
3 Biologics Control Act of 1902 Followed St. Louis disaster (diphtheria antitoxin contaminated with tetanus killed 13 children) Pre-market approval (license) to manufacture a product to be shipped in interstate commerce Registration of a manufacturer Naming of a responsible head (authorized official)
4 Pure Food and Drug Act of 1906 Progressive era, Sinclair Louis & The Jungle For preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors,. Purity and potency required (but not safety or efficacy). False claims illegal, but anything in the US Formulary or US Pharmacopea was legal if correctly labeled. Subsequent deaths from dinitrophenol, cincophen, radium, iodine, etc.
5 Food, Drug, and Cosmetics Act of 1938 Followed Elixor of Sulfanilamide disaster (sulfa in diethylene glycol labeled as elixor killed >100 people) Drugs sold in interstate commerce must be safe. Blood for transfusion is a drug. Authority with FDA
6 Drug Amendments of 1962 Followed thalidomide disaster in Germany and England (phocomelia in infants) Drugs must be safe and effective.
7 Where are we? Blood is a drug Unit of manufacture is the single donation Must be safe and effective, but that cannot be measured on every unit prospectively So we enforce purity and potency
8 The regulatory divide Blood Well understood process and highly reproducible product Minimal manipulation of the product Human cells and tissues Poorly understood processes. Highly variable products Highly manipulated product
9 Source Plasma Collection Commercial plasma collection centers using paid donors for manufactured plasma products Albumin, IVIg, RhoGam, RabiesIg, Vig All of these products undergo 4-10 log of pathogen reduction by Solvent/detergent treatment Nanofiltration Other methods
10 The safest blood comes from altruistic voluntary nonremunerated donors. WHO Global Program for Blood Safety
11 Give Blood The national blood policy established in the late 1970s requires that blood for transfusion be donated by voluntary donors. It s not a monumental effort
12 Making a blood product Define a product (like a unit of RBCs) Describe a process to make it Prove it works (under an IND) Get a license to make the product by following procedures that define the process.
13 Modern integral blood bag system
14 Making Blood Products Recruiting donors Qualifying donors Collecting whole blood Testing blood collected Making components Labeling Storage Shipment
15 Donor Suitability Blood components for transfusion Serum eye drops Plasma for fractionation Human milk Human sperm or ova Human fecal microbiota Human vaginal microbiota Human oral microbiota
16 21 CFR Suitability of donor (a) Method of determining. The suitability of a donor as a source of Whole Blood shall be determined by a qualified physician or by persons under his supervision and trained in determining suitability. a thru f: (covering or referencing just about everything)
17 cgmp Current good manufacturing practice, the model is ISO-9001 Have a quality program Have written procedures for each process Measure deviation from the process Perform root-cause evaluations into sources of deviations Minimize deviation from the process by enforcing or changing procedure
18 Blood Safety in US is a matter of FDA regulation and industry standards FDA regulations in 21 CFR 200, 600, 800, & 1270 series, 42 CFR 493w Blood collection and product manufacturing facilities are licensed and distributing facilities are registered. FDA inspections biannually Hospitals, laboratories, and blood banks are accredited by TJC, CAP, and AABB State health department license
19 CFR Title 21- Food & Drugs Chapter 1 FDA in DHHS Subchapter C Drugs: general Part 210 cgmp in manufacture, processing, packing or holding of drugs: general Sect Status of cgmp regulations Sec 210.1(b) The failure to comply with any regulation set forth in this part and in parts 211, 225, and 226 of this chapter in the manufacture, processing, packing or holding of a drug shall render such a drug to be adulterated...
20 21 CFR Quality Regulations QC/QA Personnel qualifications Personnel responsibilities Production records review Laboratory records & review Personnel Facilities Equipment Supplies, reagents SOPs Records Adverse reactions BPDs
21 21 CFR Dating periods for licensed biological products The minimum dating periods in paragraph (c) of this section are based on data related to usage, clinical experience, or laboratory tests that establish the reasonable period beyond which the product cannot be expected to yield its specific results and retain its safety, purity, and potency, provided the product is maintained at the recommended temperatures
22 Labeling Labeling of a blood product is highly regulated and all such products in the US use a schema called ISBT 128. Label can only be applied when all conditions are met.
23 Labeling Human fecal slurry for microbiotal transplant Brand name Source & address FDA Registration # Unique ID # Outdate Volume Storage instructions Reference to use instructions For administration only under the direction of a licensed physician
24 Apheresis Platelet Components Single donor platelets by apheresis must contain > 3 x per unit, but some donors can give > 600 or 900 billion at a setting, enough for 2 or 3 doses. Huge advantage because of cost of collection and testing is spread over more units single donor platelets by apheresis
25 Size of donation matters because the cost of testing is spread over the number of products produced from each donation.
26 21 CFR Testing the blood All laboratory tests shall be made on a specimen of blood taken from the donor at the time of collecting the unit of blood, and these tests shall include the following: a thru f: (covering or referencing just about everything)
27 42 CFR Condition: Immunohematology The speciality of immunohematology includes four subspecialties for the purposes of proficiency testing: ABO group and D (Rho) typing, unexpected antibody detection, compatibility testing, and antibody identification. Three times yearly proficiency testing with external quality standards CAP surveys
28 42 CFR Standard: ABO & RhD typing (a)failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. Failures are reported to your state health department, who visits you.
29 42 CFR Civil money penalty (a) Statutory basis. Sections 1846 of the Act and 353(h)(B) of the PHS Act authorize the Secretary to impose civil money penalties on laboratories. Section 1846(b)(3) of the Act specifically provides thea incrementally more severe fines may be imposed for repeated or incorrected deficiencies.
30 Washington Post, 9 Sept 2006 Regulation is designed to ensure that blood collection and product manufacturing are in compliance with laws and regulations.
31 Increased personal choice and market forces in blood collection and donation may not be useful answers.
32
33
34
35 Fecal donor for microbial tranplant guidelines suggested by the Infectious Disease Society and 4 US GI Societies in 2013
36 Welcome to AdvancingBio: offering treatment to those suffering with C. diff through Fecal Microbiotal Transplant See website of AdvancingBio Subsidiary of BloodSource, the Sacramento area blood collector
37 Thank you for all your efforts to encourage blood donation.
Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE AABB
Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director, Accreditation and Quality AABB The Beginning of Biologics Regulation Vaccines used to prevent smallpox and rabies at the end of the 19 th century Heat
More informationFDA Perspective on Plasma Quality and GMPs
FDA Perspective on Plasma Quality and GMPs Judy Ellen Ciaraldi Food and Drug Administration Division of Blood Components & Devices/OBRR/CBER IPFA/BCA Global Symposium September 23, 2014 Sacramento, California
More informationSharon Tindle, MS, CQA (ASQ) QA Manager, BMT Tissue Services Mount Sinai Hospital, New York, NY. June 7, 2016
Sharon Tindle, MS, CQA (ASQ) QA Manager, BMT Tissue Services Mount Sinai Hospital, New York, NY June 7, 2016 1 Brief description of the Mount Sinai Cellular Therapy Laboratory Overview of BM transplant
More informationOver the last 20 to 30 years, there has been a big cultural change in blood establishments: Scientific focus (Testing)
Over the last 20 to 30 years, there has been a big cultural change in blood establishments: Scientific focus (Testing) Therapeutic focus (Manufacturing) Quality & Regulatory Consultant 2 This change has
More informationError Management and BPD Reporting for the Transfusion Service. Mary A Lieb MT(ASCP)SBB, CQA(ASQ) Director, Quality Source Blood Systems,
Error Management and BPD Reporting for the Transfusion Service Mary A Lieb MT(ASCP)SBB, CQA(ASQ) Director, Quality Source Blood Systems, Objectives Define biological product deviation Explain what constitutes
More informationCopyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited.
Statutory Framework for Biologics Drugs Investigational Use Application IND Pre-Market Approval Applications 505(b)(1) NDA 505(b)(2) NDA 505(j) ANDA Over-the-Counter (OTC) Non- Rx Drugs Monograph Biologics
More informationReporting Deviations of Biological Products and HCT/Ps. Ellen Areman Senior Consultant Biologics Consulting Group, Inc.
Reporting Deviations of Biological Products and HCT/Ps Ellen Areman Senior Consultant Biologics Consulting Group, Inc. Relevant Legislation Public Health Service (PHS) Act Regulates biological products
More informationEXAMPLE OF VENDOR QUALIFICATION FOR IMMUNE EFFECTOR CELL PRODUCT MANUFACTURER
EXAMPLE OF VENDOR QUALIFICATION FOR IMMUNE EFFECTOR CELL PRODUCT MANUFACTURER Disclaimer: This example is just one potential example of a vendor qualification form to verify the adequacy of the internal
More informationUS FDA: CMC Issues for INDs
ISBTC Global Regulatory Summit October 29, 2008 US FDA: CMC Issues for INDs Keith Wonnacott, Ph.D. keith.wonnacott@fda.hhs.gov US Food and Drug Administration Center for Biologics Evaluation and Research
More informationHistory of cgmp s & FDA. Richard Lombardi, Training Specialist Forest Laboratories, Inc.
History of cgmp s & FDA Richard Lombardi, Training Specialist Forest Laboratories, Inc. ASQ June 1, 2005 Not a second thought What Ails Ya? Latham's Cathartic Extract: : Sick, headache, Impurities in the
More informationGuidance for Industry
Guidance for Industry Cooperative Manufacturing Arrangements for Licensed Biologics Additional copies of this guidance are available from the Office of Communication, Training and Manufacturers Assistance
More informationDraft Guidance for Industry. This guidance document is for comment purposes only.
Reprinted from FDA s website by EAS Consulting Group, LLC Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for
More informationInspections, Compliance, Enforcement, and Criminal Investigations
1 of 6 6/10/2009 10:36 AM Inspections, Compliance, Enforcement, and Criminal Investigations hhsbluebirddepartment of Health and Human Services Public Health Service Food and Drug Administration Dallas
More informationGuidance for Industry
Guidance for Industry Cooperative Manufacturing Arrangements for Licensed Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding
More informationCGMP Requirements for Investigational Products
PREP #6 CGMP Requirements for Investigational Products Ji-Eun Kim, RPh, PhD Research Pharmacist Regulatory Affairs Office of Research Compliance December 6, 2016 1 CME Disclosure Statement Northwell Health
More informationChanges to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
Reprinted from FDA s website by EAS Consulting Group, LLC Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Guidance
More informationCommon AABB Assessment Findings
Common AABB Assessment Findings Linda Sigg, MT(ASCP)SBB, CQA(ASQ) Staff Lead Assessor, Accreditation and Quality AABB Southeastern Area Blood Bankers Association Annual Meeting March 4-5, 2009 Introduction
More informationThe Quality Conundrum
The Quality Conundrum High Resource TM Standards in Low Resource Environments Alexander Duncan MD Centre for Transfusion & Cellular Therapies Emory University School of Medicine Case 1 29 yr old woman
More informationCompliance Program Guidance Manual Chapter 42 Blood and Blood Products
Compliance Program Guidance Manual Chapter 42 Blood and Blood Products Inspection of Licensed In-Vitro Diagnostic (IVD) Devices Regulated by CBER - 7342.008 Implementation Date: October 1, 2012 PRODUCT
More informationQuality Management. Carlos Bachier, MD
Quality Management Carlos Bachier, MD Goals of Quality Management Ensure credibility of outcomes Improve patient safety and quality of processes Significantly reduce errors Quality Medical and Laboratory
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Puget Sound Blood
More informationPathogen Inactivation and Blood Safety in the US. Richard Benjamin, MD PhD Chief Medical Officer Washington, D.C.
Pathogen Inactivation and Blood Safety in the US Richard Benjamin, MD PhD Chief Medical Officer Washington, D.C. Conflict of Interest The American Red Cross is participating in a clinical trial of the
More informationCGMP for Phase 1 INDs
CGMP for Phase 1 INDs Laurie P. Norwood Deputy Director Division of Manufacturing and Product Quality Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research 1 Overview
More informationFDA Update on Compounding
FDA Update on Compounding Julie Dohm, JD, PhD Senior Science Advisor for Compounding, Center for Drug Evaluation and Research; Agency Lead on Compounding, FDA Compounding A Snapshot Compounded drugs: Are
More informationSECTION L QUALITY ASSURANCE. 1) designating and managing quality control functions, including:
NT-L1.000 QUALITY ASSURANCE PROGRAM All NADOs shall have a QA Program. Current (2 nd Edition) NT-L1.100 BASIC ELEMENTS SECTION L QUALITY ASSURANCE The QA program shall include, at a minimum: 1) designating
More informationRegulatory Approval of Modern Gene-Based Cancer Immunotherapies CAR T Cells A product perspective
Regulatory Approval of Modern Gene-Based Cancer Immunotherapies CAR T Cells A product perspective ASQ509 Biomed/Biotech SIG 2/1/18 Xiaobin Victor Lu Division of Cellular and Gene Therapies Office of Tissues
More informationOffice for Human Subject Protection. University of Rochester
POLICY 1. Purpose Outline the responsibilities and regulatory requirements when conducting human subject research that involves the use of drugs, agents, biological products, or nutritional products (e.g.,
More informationClinical Trials and the Code of Federal Regulations. Darlene Kitterman, MBA Director, Investigator Support & Integration Services September 24, 2014
Clinical Trials and the Code of Federal Regulations Darlene Kitterman, MBA Director, Investigator Support & Integration Services September 24, 2014 The Development of Regulations 1906: Food and Drugs Act
More informationEU and FDA GMP Regulations: Overview and Comparison
THE QUALITY ASSURANCE JOURNAL, VOL. 2, 55 60 (1997) EU and FDA GMP Regulations: Overview and Comparison The increasing emphasis on global supply of drug products, as well as starting materials and investigational
More informationPharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance U.S. Department of Health and Human Services Food and Drug Administration Center for
More informationChallenges In Cell Product Labeling, Tracking And Traceability
Challenges In Cell Product Labeling, Tracking And Traceability April 4-5, 2008 Columbus, Ohio Dave Krugh, MT(ASCP)SBB, CLS,CLCP(NCA) Clinical Program Manager, BMT Program Clinical Instructor, Department
More informationRegulation of Biologics in The United States: From a Rich Tradition To A Challenging Future
Regulation of Biologics in The United States: From a Rich Tradition To A Challenging Future Chris Joneckis,, Ph.D. Senior Advisor For CMC Issues Center For Biologics Evaluation And Research Food and Drug
More informationHCT/P Regulation vs 361 Products
HCT/P Regulation - 351 vs 361 Products Presented by: Paul Gadiock February 15, 2017 Arent Fox LLP Washington, DC New York, NY Los Angeles, CA San Francisco, CA 1 Presentation Overview Introduction Public
More information6TH EDITION OF FACT-JACIE STANDARDS A QUICK SUMMARY. BHS JACIE Day, 6 March 2015 Eoin McGrath JACIE Operations Manager
6TH EDITION OF FACT-JACIE STANDARDS A QUICK SUMMARY BHS JACIE Day, 6 March 2015 Eoin McGrath JACIE Operations Manager CONTENTS Review process Sources of information Selection of main changes and developments
More informationLicense Submission Checklist for Platelets, Leukocytes Reduced Collected by Pheresis
License Submission Checklist for Platelets, Leukocytes Reduced Collected by Pheresis Purpose: To provide guidance when submitting documentation to FDA in support of a BLA or a license supplement. Definitions
More informationABO, Rh, HLA Antibodies Issues with Whole Blood NANCY M. DUNBAR, MD MEDICAL DIRECTOR, BLOOD BANK DARTMOUTH-HITCHCOCK MEDICAL CENTER, LEBANON, NH, USA
ABO, Rh, HLA Antibodies Issues with Whole Blood NANCY M. DUNBAR, MD MEDICAL DIRECTOR, BLOOD BANK DARTMOUTH-HITCHCOCK MEDICAL CENTER, LEBANON, NH, USA The Appeal of Whole Blood WHOLE BLOOD IN EXSANGUINATING
More informationQuality Agreements with CMO s. Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals
Quality Agreements with CMO s Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals FDA Guidance Contract Manufacturing Arrangements for Drugs: Quality
More informationCell and Gene Therapy Medicinal Product Management Act (Draft) General Information
Cell and Gene Therapy Medicinal Product Management Act (Draft) General Information July 2017 At present there are still many diseases that cannot be cured by current medical technology and existing chemical
More informationQuality Program: Supplies and Reagents
Quality Program: Supplies and Reagents J. Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ) Supervisor, Quality Assurance and Regulatory Affairs Department of Transfusion Medicine, Clinical Center, NIH Disclosures:
More informationMarch 9, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org March 9, 2015 Division of Dockets Management (HFA-305) Food and Drug Administration
More informationFDA Approach to the Regulation of Hematopoietic Stem/Progenitor Cells (HPC)
FDA Approach to the Regulation of Hematopoietic Stem/Progenitor Cells (HPC) Ellen Lazarus, M.D. Medical Officer Division of Human Tissues Office of Cellular, Tissue, and Gene Therapies FDA proposed approach
More informationFacility and Operational Issues for Cord Blood Banks: FDA Draft Guidance
Facility and Operational Issues for Cord Blood Banks: FDA Draft Guidance Mary Malarkey, Director Office of Compliance and Biologics Quality ISCT 7 th Annual Somatic Cell Therapy Symposium, September 26-28,
More informationSan Jose, California, USA
Glisland, Inc. San Jose, California, USA http://www.glisland.com Welcome to the Drug GMP World Current Good Manufacturing Practice cgmp ICH Q10 Pharmaceutical Quality System PQS GMP QSR Quality System
More informationRegula'on of Contracep'ves
Regula'on of Contracep'ves VETERINARY DRUG DEVELOPMENT: REGULATION OF STERILANTS AND CONTRACEPTIVES David M. Petrick, VMD, JD The Delta Consortium Regulatory Consulting Limited Copyright July, 2018 Veterinary
More informationPROVINCIAL BLOOD COORDINATING PROGRAM DEFINITIONS NLBCP-063
Government of Newfoundland and Labrador Department of Health and Community Services Provincial Blood Coordinating Program PROVINCIAL BLOOD COORDINATING PROGRAM DEFINITIONS Office of Administrative Responsibility
More informationQuality Manual. Quality Manual. Vera Bioscience / Anu Life Sciences. April 2018
Quality Manual Vera Bioscience / Anu Life Sciences April 2018 Page 1 of 15 TABLE OF CONTENTS Quality Manual Page 1. Company Overview 3 2. References 3 3. Exemptions, Alternatives and Variances 3 4. General
More informationFACT Common Standards for Cellular Therapies, Second Edition. Summary of Changes
FACT Common Standards for Cellular Therapies, Second Edition Summary of Changes This document summarizes major changes made to the Second Edition FACT Common Standards for Cellular Therapies. This summary
More informationIntroduction to GMPs and Validation WILLIAM GARVEY AND ASSOCIATES
Introduction to GMPs and Validation WILLIAM GARVEY AND ASSOCIATES William Garvey and Associates LLC 2016 Introduction About your instructor William (Bill) Garvey Important regulations and events Good Manufacturing
More informationDEPARTMENT OF HEALTH 81 HUMAN SERVICES
I. DEPARTMENT OF HEALTH 81 HUMAN SERVICES Public Health Servke Food and Drug Admlnistration I:& ;5 -. San Francisco Distinct 1431 Harbor Bay Parkway Alameda. CA 94502-7070 Telephone: 51 O/337-6700 VIA
More informationAutologous Supply Chain
Autologous Supply Chain INSIGHTS INTO THE REGULATORY CONSIDERATIONS FOR SHIPPING VALIDATION SUPPORTING NOVEL PRODUCTS - CELLULAR PRODUCTS 1 Federal Food, Drug, & Cosmetic Act(FDCA) Under Sec 501(a)(2)(B)
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Thomas E. Young,
More informationHuman Tissue Intended for Transplantation Skin, corneas, sclera, bone, heart valves, blood vessels, pericardium, tendons, cartilage, fascia
TITLE / DESCRIPTION: DEPARTMENT: Human Tissue Intended for Transplantation Skin, corneas, sclera, bone, heart valves, blood vessels, pericardium, tendons, cartilage, fascia Surgical Services PERSONNEL:
More informationStem Cell Uses and FDA Regulation
Stem cells have been called everything from cure-alls to miracle treatments. But don t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware
More informationRe: Docket No. FDA 2018-D-2478, Recommendations for Reducing the Risk of Transfusion- Transmitted Babesiosis draft guidance, July 27, 2018
September 28, 2018 Division of Dockets Management (HFA 305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Submitted via http://www.regulations.gov Re: Docket No. FDA 2018-D-2478,
More informationISBT128 Standards for Blood and Blood Components: How it Translates to Patient Safety
ISBT128 Standards for Blood and Blood Components: How it Translates to Patient Safety Diana Teo Blood Services Group Health Sciences Authority Singapore 11/12/2010 1 All Rights Reserved 2008 Health Sciences
More informationCLIA Corner. In This Issue... Common Deficiencies. Proficiency Testing Personnel Micro Quality Control
CLIA Corner The University of Iowa Hygienic Laboratory First Quarter 2006 Iowa CLIA Surveyors: Nancy Grove, BS, MT(ASCP) & Kristine Rotzoll, BS, MT(ASCP) In This Issue... Common Deficiencies Proficiency
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Celltex Therapeutics Corporation
More informationImportant Updates in USP <797> and USP <823> Eric S. Kastango, MBA, BS Pharm, FASHP Clinical IQ, LLC & CriticalPoint, LLC Madison, New Jersey
Important Updates in USP and USP Eric S. Kastango, MBA, BS Pharm, FASHP Clinical IQ, LLC & CriticalPoint, LLC Madison, New Jersey Disclosures Principal-Clinical IQ, LLC Healthcare consulting
More informationPharmaceutical Reference Standards: Overview and Role in Global Harmonization
Matthew Borer, Ph.D., Advisor Pharmaceutical Reference Standards: Overview and Role in Global Harmonization 3rd DIA China Annual Meeting Beijing, China, 16-18 May, 2011 What is a Pharmaceutical Reference
More informationFDA s Same Surgical Procedure Draft Guidance Could Stifle Use of Autologous Stem Cell Therapies
FDA s Same Surgical Procedure Draft Guidance Could Stifle Use of Autologous Stem Cell Therapies Executive Summary, June 2015 Life Sciences Practice Group AUTHOR Areta L. Kupchyk Nixon Peabody LLP Washington,
More informationImpact of WHO Guidelines on GMP for Blood Establishments
Impact of WHO Guidelines on GMP for Blood Establishments Christian Schärer, Ph.D. Swissmedic, Swiss Agency for Therapeutic Products, Head Inspectorate International Conference of Drug Regulatory Authorities
More informationDisclosures. Laboratory Stakeholders. IVD vs. LDT. FDA Regulation of Laboratory Developed Tests 10/2/2015. FDA Regulation of LDTs
Disclosures FDA Regulation of Laboratory Developed Tests Beaumont Health System, 24 th Annual Symposium on Molecular Pathology September 16, 2015 Roger D. Klein, MD JD Director, Molecular Pathology Clinical
More informationThe Role of Research in Supporting Regulation of Biologicals: Building Bridges from Biomedical Discovery to Innovative Products
The Role of Research in Supporting Regulation of Biologicals: Building Bridges from Biomedical Discovery to Innovative Products Jay S. Epstein, M.D. CBER, FDA Biologicals are Complex Products Critical
More informationCell Therapy Liaison Meeting, January 27, 2006
Cell Therapy Liaison Meeting, January 27, 2006 Bethesda, MD, Summary Attendees were welcomed by Stephen J. Noga, MD, PhD, ISCT FDA Liaison and the meeting was called to order at 8:15am. HIV and HCV NAT
More informationPrepublication Requirements
Issued Prepublication Requirements The Joint Commission has approved the following revisions for prepublication. While revised requirements are published in the semiannual updates to the print manuals
More informationSUPPLEMENTAL NOTE ON HOUSE BILL NO. 2055
Brief* SESSION OF 2017 SUPPLEMENTAL NOTE ON HOUSE BILL NO. 2055 As Recommended by House Committee on Health and Human Services HB 2055 would amend the Kansas Pharmacy Act (Act) by deleting, adding, and
More informationSerological Testing: Why we did what we did!
Serological Testing: Why we did what we did! W. John Judd, FIBMS, MIBiol Emeritus Professor University of Michigan What we did Provided blood and blood products in a timely, cost-efficient manner. Implemented
More informationQuality Assurance in Pharmaceutical and Biotech Industries as Per Regulatory Guidelines
Human Journals Review Article January 2017 Vol.:8, Issue:2 All rights are reserved by Chagi Venkatesh et al. Quality Assurance in Pharmaceutical Biotech Industries as Per Regulatory Guidelines Keywords:
More informationFACT Inspector Standards Review Questions 5 th Edition Cord Blood Standards
FACT Inspector Standards Review Questions 5 th Edition Cord Blood Standards Inspector Name: Note: A score of 90% or higher is required to achieve active inspector status. Inspector Techniques 1. As a FACT
More informationMarch 4, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
March 4, 2014 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA 2013-N-1523: Request for Nominations: Drug Products that
More informationPhase Appropriate GMPs for IMPs. Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017
Phase Appropriate GMPs for IMPs Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017 1 Lets start with References https://mhrainspectorate.blog.gov.uk/2016/0 5/20/manufacture-of-investigationalmedicinal-products-frequently-askedquestions/
More informationFood and Drug Administration (FDA) 101
Food and Drug Administration (FDA) 101 What is the Food and Drug Administration (FDA)? The FDA is an agency within the U.S. Department of Health and Human Services that is responsible for protecting the
More informationPLATELET GUIDANCE DOCUMENT
Government of Newfoundland and Labrador Department of Health and Community Services Provincial Blood Coordinating Program PLATELET GUIDANCE DOCUMENT Office of Administrative Responsibility Director, Regional
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Seite 1 von 10 Inspections, Compliance, Enforcement, and Criminal Investigations Laboratoire Atlas Inc. 6/25/09 hhsbluebird Department of Health and Human Services Public Health Service Food and Drug Administration
More informationOff-Label Use Congress and FDA must balance: The need to regulate manufacturer promotion of off-label use of devices; and The need for and availabilit
Off-Label Use Versus Clinical Trial Use of Devices: FDA Regulatory Issues Neil F. O Flaherty Principal Olsson Frank Weeda Terman Bode Matz PC Off-Label Use Uses that do not appear in a device s FDA-approved
More informationAn overview of the Asia Pacific Blood Network and Overview of the status of plasma fractionation in the region
An overview of the Asia Pacific Blood Network and Overview of the status of plasma fractionation in the region Overview» APBN Membership Vision and mission & strategic objectives Activities Plasma for
More informationUnder this license, you are approved to manufacture aflibercept drug substance intermediate, drug substance, and formulated bulk at
DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver Spring MD 20993 Our STN: BL 125387/0 BLA APPROVAL November 18, 2011 Regeneron Pharmaceuticals, Inc. Attention: Laura Pologe, Ph.D. Associate Director, Regulatory
More informationNEW YORK STATE DEPARTMENT OF HEALTH CLINICAL LABORATORY EVALUATION PROGRAM. Crosswalk of Proposed Revision to General Systems Standards
Any General Systems Standards not addressed here remain in effect. (changes are underlined) CURRENT STANDARD CURRENT GUIDANCE PROPOSED STANDARD PROPOSED GUIDANCE Quality Management System Sustaining Standard
More informationORC Sponsor-Investigator IDE Checklist
A sponsor-investigator assumes BOTH investigator and sponsor responsibilities as outlined in the FDA Code of Federal Regulations 21CFR812. This means that such investigators have additional responsibilities.
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Seite 1 von 8 Inspections, Compliance, Enforcement, and Criminal Investigations Department of Health and Human Services Public Health Service Food and Drug Administration Center for Biologics Evaluation
More informationRecent FDA Inspection Findings and Trends
Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11
More informationIrish Blood Transfusion Service Seirbhís Fuilaistriúcháin na héireann
Document Detail Irish Blood Transfusion Service Seirbhís Fuilaistriúcháin na héireann Type: Document No.: Title: PMF IBTS SPEC IBTS/PMF/SPEC/0201[2] PRODUCT MASTER FILE - GENERAL REQUIREMENTS Owner: 1066
More informationRegulatory Issues in Human Subjects Research
Regulatory Issues in Human Subjects Research Ian McNiece, PhD University of Miami Human Subjects Research Require IRB approval Studies of new drugs or applications of drugs require an FDA approved IND
More informationDrug Quality Assurance: Systems at ChemCon Author: Dr. Peter Gockel
Drug Quality Assurance: Systems at ChemCon Author: Dr. Peter Gockel On February 13th, 2006, the FOOD AND DRUG ADMINISTRATION (FDA) implemented a revision to the Compliance Program Guidance Manual for active
More informationPPTA Regulatory Workshop June 13, 2016
PPTA Regulatory Workshop June 13, 2016 DOROTY SCOTT Dr. Dorothy Scott is the Branch Chief for the Laboratory of Plasma Derivatives, in the Office of Blood Research and Review, CBER. Her group is responsible
More informationSynopsis: FDA Process Validation Guidance
Synopsis: FDA Process Validation Guidance This synopsis is a comparison of the draft version 2008 and the final version 2011 of the U.S. FDA Guidance Process Validation: General Principles and Practices.
More informationGood manufacturing practices
ORIGINAL PAPER 1AR-10 ISBT Science Series (2009) 4, 6 10 Journal compilation 2009 International Society of Blood Transfusion Good manufacturing practices Blackwell Publishing Ltd A. Ahmed Quality Manager,
More informationNotice of Rulemaking Hearing
Department of State Division of Publications 312 Rosa L. Parks, 8th Floor SnodgrassfTN Tower Nashville, TN 37243 Phone: 615.741.2650 Fax: 615.741.5133 Email: register.information@tn.gov For Department
More informationA Life Cycle Approach to Raw Material Qualification for Cell and Gene Therapy Products
A Life Cycle Approach to Raw Material Qualification for Cell and Gene Therapy Products Angela Whatley, Ph.D. Office of Tissues and Advanced Therapies CBER/FDA CMC Strategy Forum on Cell & Gene Therapies
More informationCompounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry;
This document is scheduled to be published in the Federal Register on 05/19/2015 and available online at http://federalregister.gov/a/2015-11982, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationThe Emerging Role of Post-Market Evidence Generation in Decision-Making: Linkages to the Product Lifecycle Approach
The Emerging Role of Post-Market Evidence Generation in Decision-Making: Linkages to the Product Lifecycle Approach CADTH Symposium April 6, 2009 Maurica Maher, MD, MSc Associate Director Office of Legislative
More informationRegulation of Microbiota- Based Products
Regulation of Microbiota- Based Products LCDR Matthew Steele, PhD Team Leader, Regulatory Review Branch 1 Division of Vaccines and Related Products Applications CBER/OVRR My presentation is an informal
More informationLaboratory: Document Type: Original Date Adopted: Previous Document: Transfusion Services Procedure 04/01/02 TRB-9 Revision 4
Laboratory: Document Type: Original Date Adopted: Previous Document: Transfusion Services Procedure 04/01/02 TRB-9 Revision 4 Document Author: Document Owner: Acknowledgement / Required Copy Holders*:
More informationPlasma for Fractionation
www.pei.de Plasma for Fractionation Regulatory & Quality Standards in the EU Dr. Sabine Wegehaupt Inspection Services for Biological Medicinal Products IPFA Workshop Stellenbosch December 01-02, 2015 Plasma
More informationProficiency Testing Turning Pitfalls into Positive Outcomes
Proficiency Testing Turning Pitfalls into Positive Outcomes Presented by: Margaret Blaetz, CLC, MLT(AMT), CCCP(AAPOL) CEO/Technical Consultant East Coast Clinical Consultants, LLC National Manager of Laboratory
More informationGuidance for Industry Compounding Animal Drugs from Bulk Drug Substances
#230 Guidance for Industry Compounding Animal Drugs from Bulk Drug Substances DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this
More informationImplementing 7 Day Platelet Dating with the Platelet PGD Test
Implementing 7 Day Platelet Dating with the Platelet PGD Test The Verax Biomedical Platelet Pan Genera Detection (PGD ) Test is a rapid, qualitative immunoassay for the detection of aerobic and anaerobic
More informationBIOVIGILANCE IN THE UNITED STATES: Regulatory Perspective
BIOVIGILANCE IN THE UNITED STATES: Regulatory Perspective Alan E. Williams, Ph.D. Office of Blood Research and Review Center for Biologics Evaluation and Research US Food and Drug Administration 15th International
More informationStarting from Scratch: Experiences with a Focused Apheresis Service
Starting from Scratch: Experiences with a Focused Apheresis Service University of Virginia Tamila Kindwall-Keller, DO, MS September 21, 2018 Disclosures Medical Monitor for BMT CTN 1301 Back Up Medical
More informationStructure and Mandate of FDA
Structure and Mandate of FDA Leonard Sacks, M.D. Office of Medical Policy Center for Drug Evaluation and Research FDA FDA Clinical Investigator Training Course November 13, 2018 Mission of regulatory agencies
More information