US Regulatory Requirements: Clinical & Clinical Research Production, SPECT & PET Radiopharmaceuticals (RPs)
|
|
- Benedict Ambrose Pearson
- 6 years ago
- Views:
Transcription
1 US Regulatory Requirements: Clinical & Clinical Research Production, SPECT & PET Radiopharmaceuticals (RPs) 20 th International Symposium Radiopharmaceutical Sciences Jeju, Korea Pre-Symposium Workshop May 12, 2013 Sally W. Schwarz, M.S., B.C.N.P. Director Clinical PET Radiopharmaceutical Production Washington University St. Louis Department of Radiology
2 US FDA Regulations: SPECT & PET RP Clinical Production (CGMP) Regulations: 1) 21 CFR Part 211 SPECT: The regulation contains the minimum Current Good Manufacturing Practice (CGMP) for preparation of drug products (excluding PET) for administration to humans 2) 21 CFR Part 212 PET as of June 2012
3 Clinical Production (CGMP) 21 CFR Part 211 SPECT: The regulation contains the minimum Current Good Manufacturing Practice (CGMP) for preparation of drug products (excluding PET) for administration to humans Must file New Drug Application (NDA) or Abbreviated Drug Application (ANDA) with FDA Air Quality is defined for production areas e.g. ISO Class 7, buffer area (clean room), airlock, ante room Testing requirements different than Part 212 Examples: Production of all Tc-99m sterile kits used for compounding Ga-67 Citrate Injection Tl-201 Chloride Injection Mo-99/Tc-99m generators Clinical Practice Using SPECT RP: follow USP Chapter <797>
4 Clinical Production (CGMP) Regulations: 2) 21 CFR Part 212 PET as of June 2012 The regulation contains the minimum Current Good Manufacturing Practice (CGMP) for preparation of PET drugs for administration to humans Air Quality only defined for Laminar Flow Hood (ISO Class 5) Testing requirements different than Part 211 unique quality of PET drugs Must file New Drug Application (NDA) or Abbreviated Drug Application (ANDA) with FDA Examples : F-18 FDG Injection F-18 Fluoride Injection N-13 Ammonia Injection C-11 Choline Dispensing PET drugs: follow USP Chapter <797>
5 Good Manufacturing Practice (CGMP) Regulations 21 CFR Part 2ll CGMP for Finished Pharmaceuticals Subpart A--General Provisions Subpart B--Organization and Personnel Subpart C--Buildings and Facilities Subpart D--Equipment Subpart E--Control of Components and Drug Product Containers and Closures Subpart F--Production and Process Controls Subpart G--Packaging and Labeling Control Subpart H--Holding and Distribution Subpart I--Laboratory Controls Subpart J--Records and Reports Subpart K--Returned and Salvaged Drug Products 21 CFR Part 212 CGMP For Positron Emission Tomography Drugs Subpart A: General Provisions Subpart B: Personnel and Resources Subpart C: Quality Assurance Subpart D: Facilities & Equipment Subpart E: Control of Components, Containers, & Closures Subpart F: Production & Process Controls Subpart G: Laboratory Controls Subpart H: Finished Drug Product Controls & Acceptance Subpart I: Packaging and Labeling Subpart J: Distribution Subpart K: Complaint Handling Subpart L: Records
6 Clinical Research Production 1) New Drugs First in Man: require Investigational New Drug Application (IND) (Rule: FDA 21 CFR Part 312) Phase 0: Proof of concept Phase 1: Tolerability studies metabolism and pharmacologic action, side effects, SAR, explore biological phenomena or disease process Phase 2: Evaluate effectiveness Phase 3: Effectiveness and safety--commercialization 2) Exploratory IND (EIND or eind) 2004 Phase 0 3) SPECT RP: Phase1 IND In vivo diagnostics are exempt from 21 CFR Part 211 requirements Production of Phase 1 SPECT drugs: FDA Guidance for Industry: CGMP for Phase 1 Investigational Drugs, July 2008; Phase 2-3: must follow Part 211 (Information at 4) PET RP: PET and SPECT Clinical Research Phase 0, 1 and 2: allows production of Investigational PET drugs according to either USP <823> or Part 212 Phase 3: must follow Part 212 FDA Guidance: IND Applications for PET Drugs, February ) Drugs with known human pharmacology may be produced under Radioactive Drug Research Committee (RDRC) (21 CFR Part 362)
7 USA Regulatory Pathway for Radiopharmaceuticals Radiotracers subject to same process as development of new therapeutic pharmaceutical: PET/SPECT Radiotracer First in humans? Yes No EIND Phase 0 *Radioactive Drug Research Committee (RDRC) * FDA oversight IND Clinical Phase 0-1, 2, & 3 Approval
8 What are the components of a US Investigational New Drug (IND) Application? 21 CFR Part 312 General investigational plan Investigator s brochure, if required Protocol(s) Chemistry Manufacturing & Controls (CMC) Production Process Quality Control Process Pharmacology and Toxicology--2 species Previous human experience Dosimetry Estimates (not specified section)
9 Exploratory IND Guidance 2006 Microdose: 1/100 th of the dose calculated to yield a pharmacologic effect Introduced in European Union, 2004 Mass dose 100 µg (protein products 30 nmoles) Reduced pharmacology, toxicology requirements One mammalian species (both sexes) 100 times human dose Study period 14 days Phase 0 studies Subject enrollment: number not stated in the guidance Transition to Phase 1 IND
10 Exploratory IND Facilitates first-in-human imaging studies Biologics Drugs Bridges preclinical --- Phase 0 to Phase 1 Ideal for proof-of-mechanism studies (POM)
11 Radioactive Drug Research Committee (RDRC) 21 CFR Part 361 Purpose: to study basic research No clinical decisions allowed Pharmacology must be known in humans Drug generally recognized as safe and effective (GRASE) No observed pharmacological effect can be noted from mass dose administered (NOEL) No First in Human Studies Radiation Dose Limits: adults and children (10% of adult radiation dose is maximum, often not adequate) Regulatory revisions needed in pediatric dose limits Federal funding requires children be included in studies
12 SPECT Clinical Research 1) SPECT RP: Phase1 IND in vivo diagnostics are exempt from 21 CFR Part 211 requirements Production of Phase 1 SPECT drugs: FDA Guidance for Industry: CGMP for Phase 1 Investigational Drugs, July ) GCMP during Phase 1 Well-defined, written procedures Adequately controlled equipment and manufacturing environment Accurately & consistently recorded data from manufacturing and testing 3) Available technologies & resources Use of Disposable equipment & processes Prepackaged Materials (e.g. Water for Injection, pre-sterilized containers & closures) Use closed process equipment alleviate need for stricter room classification for air quality 4) FDA Guidance: CGMP for Phase 1 Investigational Drugs Sterile Drug Products Produced by Aseptic Processing--CGMP
13 What is the United States Pharmacopeia? United States Pharmacopeia (USP): Sets legal, enforceable standards for drugs (including radiopharmceuticals) in the United States General Chapters under 1000 are enforceable General Chapters over 1000 are for information Chapter <797> and <Chapter <823>
14 United States Pharmacopeia (USP) Chapter <797>: Pharmaceutical Compounding Sterile Preparations (CSPs) (official June 2008) Risk Levels: assigned according to potential for microbial contamination during compounding Low Medium High: Non-sterile components Immediate-use Chapter <823>: Radiopharmaceuticals for Positron Emission Tomography (PET) Compounding (32 nd edition, official 1998)
15 USP Chapter 797 Pharmaceutical Compounding Sterile Preparations Compounded Sterile Preparation = CSP CSPs include any of the following: compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals Compounding, for purposes of this chapter, includes preparation of manufactured sterile products, whether or not according to package insert instructions includes transfer of sterile products from one container to another (e.g., transfer of sterile liquid from a vial into a sterile syringe) BUD = beyond use date
16 USP Chapter 797 Pharmaceutical Compounding Sterile Preparations Low Risk: BUD Time 12 h Compounded from sterile components in ISO Class 5 Mixing 3 sterile products & 2 entries into sterile vial Located in ISO Class 8 or segregated compounding area (Most traditional Tc-99m RPh are included) Medium Risk: White Blood Cells High Risk: Non-sterile components used in the production ( 123 I-MIBG) Immediate-use: prepare and dispense within 1 h ( 99m Tc-MAA)
17 International Organization of Standardization of Particulate Matter in Room Air Class Name Particle Count* Grade ISO Class U.S. FD 209E ISO Class Class A and B 5 Class Class ,200 C 7 Class 10, ,000 D 8 Class 100,000 3,520,000 * particles 0.5 µm and larger per cubic meter ISO Class 5 (Grade A) Laminar Flow Enclosure
18 Low-Risk Level CSP with 12 Hr BUD If the ISO Class 5 primary engineering control (e.g., laminar flow hood) NOT located in an ISO Class 7 buffer area (clean room), then the maximum BUD for low-risk level CPS is 12 hours
19 Facility Design Low-Risk Level CSP with 12-hour BUD ISO Class 5 device Segregated Compounding Area Critical Site Low-Risk Level CSP with 12-Hour BUD
20 USP Chapter <797> Low-Risk RP as CSPs ISO Class 5 Primary Engineering Control (PEC) Designated Space Demarcated area or Separate room Evaluate for ISO Class 8 conformity Restricted to prep CSPs with 12 h Beyond Use Dating (BUD) No unsealed windows No connection to outdoors or high traffic flow No sinks next to ISO Class 5 PEC Personnel Garbing
21 SPECT RP Dose Drawing Area Laminar Flow Hood: ISO Class 5 Syringe and Vial Shield L-Shield
22 Chapter <797> Low-Risk RP as CSPs Generator storage in demarcated area Generator may be eluted in ISO Class 8 environment
23 Chapter <797> High-Risk RP Compounding High Risk Conditions: Facility Design Example: Dissolving non-sterile components to make solutions that will be terminally sterilized MIBG sterile powder Radiochemical grade I-123 ISO Class 7 buffer area (cleanroom) ISO Class 8 ante area Critical area ISO Class 5 device
24 Terminal Filtration in ISO Class 5 Terminal Sterilization performed Move reaction to ISO Class 5 environment Using 0.22 m sterile filters Bubble Test sterile filter post preparation
25 Why is PET Unique? Short half-life, usually minutes to hours High energy radionuclides (5ll kev) Batch produced provides a limited supply usually hours and can be produced for a single dose Mass contained in the final product is usually nanogram-microgram Quality control issues due to short half-life Complete quality control testing performed for every batch, all but sterility testing is pre-release
26 FDA Published Final Rule 21 CFR Part 212; Current Good Manufacturing (CGMP) for Positron Emission Tomography (PET) Drugs December 10, 2009 Regulation became effective June 12, 2012 Regulation applies solely to PET drugs for routine clinical use Submission of an New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) required for all FDA PET drugs no later than 2 years from the date of publication of the Final Rule. (Extended to 6/12/12) F-18 FDG, F-18 Fluoride, N-13 Ammonia considered safe & effective for certain uses when produced under conditions specified in approved applications
27 21 CFR Part 212; Final Rule CGMP for PET Drugs December 10, 2009 The rule 212.5(b) provides that investigational and research PET drugs, CGMP may be met by producing PET drugs in accordance with Part 212, or in accordance with USP General Chapter <823> Radiopharmaceuticals for Positron Emission Tomography Compounding, May 1, 2009, 32 nd Edition, and USP Monographs if available 1. PET Drugs produced under Investigational New Drug (IND) Application in accordance with Part 312 of this chapter or 2. PET Drugs approved through a Radioactive Drug Research Committee (RDRC) in accordance with Part 361 of this chapter FDA has indicated that IND Phase 0, 1 and 2 are research. Phase 3 usually indicates moving to commercialization & must follow Part 212.
28 FDA Guidance What is an FDA Guidance? Guidance describes FDA s current thinking on individual issues addressed by the CGMP rule that is not binding on FDA or the public. Guidance documents recommend approaches to complying with statutory requirements or regulations. Not binding requirements Guidance are suggestions how to comply with the broad requirement Part 212 Part 212 is broad requirement Guidance: PET Drugs-Current Good Manufacturing Practices Chapter <823> USP <823> contains many essential elements of CGMP The organization of USP <823> is not as vague as Part 212, it provides more specifics
29 USP <823> Part 212 PET CGMPs Investigational PET radiotracers IND = Clinical Trial/Research RDRC Basic science only Not for diagnosis or therapy Not for safety or efficacy Pharmacology must be known in humans Mass dose no pharmacological effect Radioactive dose limit Clinical PET radiopharmaceuticals Drugs administered as part of clinical care Information used to guide patient care decisions Approved under NDA/ANDA Legally marketed For sale Interstate distribution
30 USP <823> Specifies Procedures/Processes: Components, Materials and Supplies Compounding Procedure Verification Acceptance Criteria Compounding Procedures Computers & Automated Equipment Controls Verification studies (3 consecutive runs) Stability Testing & Expiration Dating PET RP Compounding for Human Use Quality Control Sterilization & Sterility Assurance Part 212 PET CGMPs Describes Accountabilities/Assurances of Quality Systems: Subpart A: General Provisions Subpart B: Personnel and Resources Subpart C: Quality Assurance Subpart D: Facilities & Equipment Subpart E: Control of Components, Containers, & Closures Subpart F: Production & Process Controls Subpart G: Laboratory Controls Subpart H: Finished Drug Product Controls & Acceptance Subpart I: Packaging and Labeling Subpart J: Distribution Subpart K: Complaint Handling Subpart L: Records
31
32 Thank-you!
for IND and RDRC Regulated PET Compounding
Overview of USP Chapter for IND and RDRC Regulated PET Compounding Distributed Manufacturing of PET Radiopharmaceuticals for Multi-Center Clinical Trials SNM, Annual Meeting Toronto, Ontario, Canada
More informationUSP Chapter 823 USP 32 (old) vs. USP 35 (new)
USP Chapter 823 USP 32 (old) vs. USP 35 (new) Sally W. Schwarz, MS, BCNP Research Associate Professor of Radiology Washington University School of Medicine St. Louis, MO Why USP Chapter ? FDA has
More informationOverview of FDA Regulations and Guidance Documents related to PET Drug Chemistry. Steve Zigler, Ph.D. Siemens PETNET Solutions
Overview of FDA Regulations and Guidance Documents related to PET Drug Chemistry Steve Zigler, Ph.D. Siemens PETNET Solutions Employee of Siemens-PETNET Solutions I will not discuss investigational agents,
More informationRole of USP Monographs and. General Chapters. Steve Zigler, Ph.D.
Role of USP Monographs and General Chapters Steve Zigler, Ph.D. Siemens PETNET Solutions USP Disclosure I have served as a USP volunteer in the area of PET drugs for 15 years Member of various Expert Committees
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 informationLatest USP Initiatives: Monographs, General Chapters, and Compounding
Latest USP Initiatives: Monographs, General Chapters, and Compounding Jim Ponto, MS, RPh, BCNP Disclosures Volunteer member on several USP Expert Committees and Expert Panels associated with radiopharmaceutical
More informationSterile Compounding elearning Course Curriculum 28 lessons with 33 hours of CE. Fundamentals of Sterile Compounding (8 lessons/8 hours CE)
Sterile Compounding elearning Course Curriculum 28 lessons with 33 hours of CE CriticalPoint s Sterile Compounding elearning curriculum is written by industry experts and covers both Chapter and
More informationBench to Bedside - The Roadmap Chemistry, Manufacturing, and Controls Issues in Radiopharmaceutical Applications
Bench to Bedside - The Roadmap Chemistry, Manufacturing, and Controls Issues in Radiopharmaceutical Applications 55 th Annual Meeting of the Society of Nuclear Medicine New Orleans, LA, June 14-18, 18,
More informationGuidance. Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs DRAFT GUIDANCE
Guidance Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and
More informationPHYSICO-CHEMICAL, BIOLOGICAL OR MICROBIOLOGICAL TESTS OF MEDICINAL PRODUCTS
RADIOPHARMACEUTICALS Guideline Title Radiopharmaceuticals Legislative basis Directives 65/65/EEC, 75/318/EEC as amended, Directive 89/343/EEC Date of first adoption December 1990 Date of entry into June
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 informationLUNCH AND LEARN. October 14, CE Activity Information & Accreditation
LUNCH AND LEARN USP Chapter : What s on the Radar? October 14, 2016 Featured Speaker: Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery
More informationEnsuring Quality Pharmacy Compounding: Implications for Pharmaceutics Education
Ensuring Quality Pharmacy Compounding: Implications for Pharmaceutics Education Loyd V. Allen, Jr., Ph.D. Professor & Chair Emeritus University of Oklahoma HSC College of Pharmacy Editor-in in-chief International
More informationHarmonizing FDA Regulation and the Practice of Pharmacy: Challenges and Opportunities. Plus an update on PET Drug User Fees
Harmonizing FDA Regulation and the Practice of Pharmacy: Challenges and Opportunities Plus an update on PET Drug User Fees Michael Nazerias - Vice President, RA/QA PETNET Solutions, Inc. (a Siemens Company)
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 informationPosiRx. automated radiopharmaceutical system
PosiRx automated radiopharmaceutical system introducing PosiRx : Positron Corporation would like to introduce PosiRx, the future of radiopharmaceutical dose preparation and delivery. PosiRx is a radiopharmaceutical
More informationOverview of a sterility assurance program for PET drugs
Coalition for PET Drug Approval Radiopharmaceutical Sciences Council Overview of a sterility assurance program for PET drugs Eric Webster, PETNET Solutions Disclosures Employee of PETNET Solutions, a Siemens
More informationDraft Guidelines for Radiopharmacy
Draft Guidelines for Radiopharmacy In the nuclear medicine laboratories (radiopharmacies) of nuclear medicine clinics in European hospitals, quality assurance varies from non-existent to good manufacturing
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 informationBRIEFING 797 PHARMACEUTICAL COMPOUNDING STERILE PREPARATIONS INTRODUCTION
1 of 58 8/20/2010 9:20 PM BRIEFING 797 Pharmaceutical Compounding Sterile Preparations, USP 32 page 318. As a result of frequently asked questions from compounding practitioners and continuous reassessment
More informationThe Device Side of Combination Products
The Device Side of Combination Products Technical and Regulatory Challenges in Life Cycle Management Bob Laughner Associate Director, Combination Products 04 May 2016 What are combination products? Combination
More informationChapter WAC Compounding Practices Crosswalk
Chapter 246-878 WAC Compounding Practices Crosswalk Draft WAC Language WAC 246-878-001 Purpose. 1) The requirements of this chapter apply to any person or facility that possesses a license under 18.64
More informationSupply of IND Agents to Multi-center trials by Skilled Academic Sites
Supply of IND Agents to Multi-center trials by Skilled Academic Sites Paula M. Jacobs, Ph.D. Associate Director, Division of Cancer Treatment and Diagnosis, NCI Cancer Imaging Program June 2016 SNMMI San
More informationPharmacy Compounding: Infection Prevention
Pharmacy Compounding: Infection Prevention Sam Eberwein, PharmD, MS, BCPS Clinical Manager, Sterile Products Area, Perioperative Services, & Special Formulations UNC Medical Center Department of Pharmacy
More informationBG75 [ 18 F] Multi Tracer CPM Automated [ 18 F]FDG/NaF/FMISO/FLT Production & QC
Automated [ 18 F]FDG/NaF/FMISO/FLT I. SUMMARY: D. Hillesheim Ph.D., J. Abner, D. Ferguson, M. Khachaturian, Ph.D. ABT Molecular Imaging, R & D, Louisville TN, 37777. www.abt mi.com This white paper presents
More informationLatest Developments in USP Monographs and the Compounding of Sterile Radiopharmaceuticals. Jim Ponto, MS, RPh, BCNP
Latest Developments in USP Monographs and the Compounding of Sterile Radiopharmaceuticals Jim Ponto, MS, RPh, BCNP Disclosures Volunteer member on several USP Expert Committees and Expert Panels associated
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 informationResponding to an FDA 483
Responding to an FDA 483 Jim Melancon VP, Associate General Counsel BioScrip, Inc. Marc Stranz, PharmD Healthcare Consultant Disclosure The speakers declare no conflicts of interest or financial interest
More informationFacility Design for Pharmacy Operation. Full-Scale Nuclear. Slides are not to be reproduced without permission of author.
Facility Design for Pharmacy Operation Full-Scale Nuclear in a Hospital Setting Neil A. Petry, MS, RPh, BCNP, FAPhA Clinical i l Assistant t Professor in Radiology Director, Radiopharmacy Services Duke
More informationAnnex A2. Guidance on Process Validation Scheme for Aseptically Processed Products
Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products 1 Table of content 1 PURPOSE... 3 2 SCOPE... 3 3 GENERAL INFORMATION... 3 4 INFORMATION NEEDED FOR ASEPTIC PROCESSES VALIDATION...
More informationLessons learned: NCI s FLT F-18 IND and F-18 NaF NDA. Paula M. Jacobs, Ph.D. Deputy Associate Director, DCTD. NCI Cancer Imaging Program
Lessons learned: NCI s FLT F-18 IND and F-18 NaF NDA Paula M. Jacobs, Ph.D. Deputy Associate Director, DCTD. NCI Cancer Imaging Program April 13, 2010 Disclaimers Opinions are mine alone NCI, NIH, and
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 informationThe Role of Chemists in the FDA Drug Approval Process
The Role of Chemists in the FDA Drug Approval Process 231 st ACS National Meeting Atlanta, GA M. Scott Furness, Ph.D. March 26, 2006 Introduction Presentation Outline FDA Organization CDER Organization
More informationHot Topics in Drug Product Process Validation: A Reviewer s Perspective
Hot Topics in Drug Product Process Validation: A Reviewer s Perspective Colleen Thomas, Ph.D. Quality Assessment Lead (Acting) FDA/CDER/OPQ/OPF Division of Microbiology Assessment CASSS CMC Strategy Forum
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 informationMicrosphere Brachytherapy Sources and Devices
Microsphere Brachytherapy Sources and Devices REVISED AUGUST 2008 Questions should be directed to: Ashley Tull (240) 888-7129 or Ronald Zelac (301) 415-7635 or MedicalQuestions.Resource@nrc.gov Licensing
More informationUSP<797> AND THE ASEPTIC PROCESSING OF RADIOPHARMACEUTICALS PART 1
USP AND THE ASEPTIC PROCESSING OF RADIOPHARMACEUTICALS PART 1 INTRODUCTION The learner was introduced to the guidelines of USP Chapter in a previous Continuing Education lesson, USP Compliance
More informationRegulatory Implications for Global Manufacturing Development of Regenerative Medicines
Regulatory Implications for Global Manufacturing Development of Regenerative Medicines Katherine Tsokas, JD June 2017 Global Regulatory Affairs Janssen Research & Development, LLC Jessica Riley, Shells
More informationá797ñ PHARMACEUTICAL COMPOUNDING STERILE PREPARATIONS
626 á795ñ Pharmaceutical Compounding Nonsterile / Physical Tests USP 39 Vehicle: A component for internal or external use that is used as a carrier or diluent in which liquids, semisolids, or solids are
More informationEnvironmental Monitoring of Aseptic Processing Areas - 1
Environmental Monitoring of Aseptic Processing Areas - 1 A war against an invisible enemy DCVMN - Víctor Maqueda - May 30, 31, June 1 2016 1 Training Course Agenda Overview of Environmental Monitoring
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 informationGuidelines: c. Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical
Guidelines for the Submission of an Expanded Access IND to Permit Diagnosis, Monitoring or Treatment of Intermediate-size Patient Populations with an Investigational Drug or a REMS-restricted, Approved
More informationFDA s Guidance for Industry
Sterile Drug Products Produced by Aseptic Processing - CGMPs Midwest FDC Conference November 4 2005 Susan Bruederle, Investigator FDA / ORA / Central Region Chicago District / Hinsdale IL FDA s Guidance
More information~ ADIOPHARMACEUTICALS
NRC and FDA Regulations Affecting Nuclear Pharmacy Practice Neil A. Petry Radiopharmaceuticals are radioactive drugs that are used in nuclear medicine practice for diagnosis and treatment of disease. Nuclear
More informationCritical Environment Products and Services
Critical Environment Products and Services For over two decades, EP Scientific products and services have defined clean for environmental sampling containers and services. Our proprietary cleaning methods
More informationPharmacy Quality Assurance Commission Sterile Compounding [USP <797>] Self-Assessment Compliance Checklist
STATE OF WASHINGTON Pharmacy Quality Assurance Commission Sterile Compounding [USP ] Self-Assessment Compliance Checklist Introduction: This checklist includes the reported principal competencies,
More informationpositron emission tomography (PET) is an exceptionally INDs for PET Molecular Imaging Probes Approach by an Academic Institution SPECIAL TOPIC
Mol Imaging Biol (2014) 16:441Y448 DOI: 10.1007/s11307-014-0735-2 * The Author(s), 2014. This article is published with open access at Springerlink.com Published Online: 15 April 2014 SPECIAL TOPIC INDs
More informationMINIMUM REQUIREMENTS FOR A VENDOR
MINIMUM REQUIREMENTS FOR A VENDOR When outsourcing the production of sterile products the first step in vendor evaluation is to see if they meet the minimum requirements. We ve developed a group of questions
More informationEarly Development Best Practices for Stability- Regulatory Perspective
Early Development Best Practices for Stability- Regulatory Perspective IQ Workshop, Feb. 4-5, 2014, Washington, D.C. Ramesh Sood, Ph.D. Division Director (Acting) Office of New Drug Quality Assessment
More informationUSP 797 & 800 Pharmacy Overview. (Presented to Vermont Chapter of New England Healthcare Engineers May 2016)
USP 797 & 800 Pharmacy Overview (Presented to Vermont Chapter of New England Healthcare Engineers May 2016) Overview Background and Regulatory Need United States Pharmacopeia (USP) 797 Purpose/Goals USP
More informationWhere Quality Meets Flexibility
Where Quality Meets Flexibility is an industry leading 503B Outsourcing Facility providing sterile and non-sterile compounding services to hospitals, surgery centers, clinics, researchers & patients nationwide.
More informationBeth Hutchins, PhD PhRMA ICH Gene Therapy Discussion Group
ICH Considerations on General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors and Current Topics on Gene Therapy in USA Beth Hutchins, PhD PhRMA ICH Gene Therapy
More informationCombination products Updates Final FDA Guidance
Compliance Seminars Combination products Updates Final FDA Guidance Presented by Anna Lundén Webinar, March 8, 2017 Intentionally blank Compliance Seminars Our international course program for GMP professionals
More informationFDA > CDRH > CFR Title 21 Database Search
Seite 1 von 7 FDA Home Page CDRH Home Page Search A-Z Index 510 (k) Registration Listing Adverse Events PMA Classification CLIA CFR Title 21 Advisory Committees Assembler Recalls Guidance Standards New
More informationExpanded Access and the Individual Patient IND
Expanded Access and the Individual Patient IND Research Wednesdays April 26, 2017 Erika Segear Johnson, PhD, RAC Associate Director of Regulatory Affairs Office of Regulatory Affairs and Quality Office
More informationFLORIDA SOCIETY OF HEALTH SYSTEM PHARMACISTS NOVEMBER 4, 2016 JAMES T WAGNER CONTROLLED ENVIRONMENT CONSULTING
Engineering Controls for Compliance with USP Chapters and FLORIDA SOCIETY OF HEALTH SYSTEM PHARMACISTS NOVEMBER 4, 2016 JAMES T WAGNER CONTROLLED ENVIRONMENT CONSULTING Learning and Performance
More informationPhEn-602 Notes # 4 J. Manfredi
PhEn-602 Notes # 4 J. Manfredi Spring 2009 1 Basic definitions Clean Room: A room in which the concentration of airborne particles is controlled and contains one or more clean zones Clean Zone: A defined
More informationUSP <797> Compliance Common Challenges and Potential Solutions
USP Compliance Common Challenges and Potential Solutions Angela Yaniv, Pharm.D Assistant Director - Sterile Products May 2, 2017 - OSHP Annual Meeting Angela Yaniv has no actual or potential conflict
More informationRegulatory perspectives on CQAs, CPPs, and Risk Analyses for Combination Products.
Regulatory perspectives on CQAs, CPPs, and Risk Analyses for Combination Products. 3rd FDA/PQRI Conference on Advancing Product Quality March 22-24, 2017 TRACK #2 Achieving Drug Product Quality: Novel
More informationGuidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center
More informationUNDER SECRETARY FOR HEALTH S INFORMATION LETTER MICROBIOLOGICAL ASSESSMENT OF PHARMACEUTICAL CLEANROOMS
DEPARTMENT OF VETERANS AFFAIRS Veterans Health Administration Washington DC 20420 IL 10-2006-008 In Reply Refer To: 10NB UNDER SECRETARY FOR HEALTH S INFORMATION LETTER MICROBIOLOGICAL ASSESSMENT OF PHARMACEUTICAL
More informationUniversity of Maryland Baltimore. Radiation Safety Procedure
University of Maryland Baltimore Procedure Number: 2.1 Radiation Safety Procedure Title: Ordering, Receiving, Opening, And Transferring Packages Containing Revision Number: 0 Technical Review and Approval:
More informationReference Standards for Monoclonal Antibodies: Key Challenges Addressed
CASSS WCBP 2012: 16th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products January 23-25, 2012 Reference Standards for Monoclonal Antibodies: Key Challenges
More informationStudy Summary. Results: All tested media-filled vials were negative for growth of any microorganisms.
A 7 Days Microbial Ingress Test of Single Use Vials Utilizing the EQUASHIELD Closed System Drug Transfer Device Study by Nelson Laboratories (Salt Lake City, UT) 2013, updated in 2014* Study Summary Abstract:
More informationAW-Information sheet Authorisation documentation for radiopharmaceuticals NAS
List of questions 1 Objective... 2 2 Scope... 2 3 Other valid documents... 2 4 Documentation... 2 4.1 Administrative documents (Module 1)... 2 4.1.1 Form: Declaration of radiopharmaceuticals... 2 4.1.2
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 informationGood manufacturing practices
The rules governing medicinal products in the European Union Volume 4 Good manufacturing practices Medicinal products for human and veterinary use 1998 Edition EUROPEAN COMMISSION Directorate General III
More informationGlobal Clinical Trials in Korea
Global Clinical Trials in Korea In-Sook Park Department of Drug Evaluation Korea Food & Drug Administration Contents Regulatory changes relevant to Clinical Trials in Korea Current Status of Clinical Trials
More informationQuality is Our Promise.
Quality is Our Promise. Our goal at KRS Global Biotechnology is to provide the highest quality pharmaceutical preparations. We accomplish this with an unrivaled quality assurance and quality control program
More informationAnalytical Methods Development and Validation
Understanding and Implementing Efficient Analytical Methods Development and Validation Jay Breaux, Kevin Jones, and Pierre Boulas Analytical methods development and validation play important roles in the
More informationIs FMT A Drug? Lance Shea, M.S., J.D. Washington Square, Suite Connecticut Ave., NW Washington, DC, D
Is FMT A Drug? Lance Shea, M.S., J.D. Washington Square, Suite 1100 1050 Connecticut Ave., NW Washington, DC, 20036 D 202-861-1648 LShea@bakerlaw.com FMT Scenarios Intra-Office Bank Product The Issue The
More informationInt. J. Pharm. Sci. Rev. Res., 31(2), March April 2015; Article No. 04, Pages: A Review on Drug Approval in Regulated and Non-Regulated Markets
Review Article A Review on Drug Approval in Regulated and Non-Regulated Markets Vemuri Pavan Kumar, N Vishal Gupta* Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy,
More informationGMP and Quality Control: An Industry Perspective. Steven S. Zigler, Ph.D. PETNET Pharmaceuticals, Inc. Knoxville, Tennessee
GMP and Quality Control: An Industry Perspective Steven S. Zigler, Ph.D. PETNET Pharmaceuticals, Inc. Knoxville, Tennessee GMP in Preparation of Precursors Not necessary However, we need stability data
More informationSTIMULI TO THE REVISION PROCESS
Page 1 of 6 STIMULI TO THE REVISION PROCESS Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts USP's Nomenclature Initiatives Angela G. Long, M.S.; Andrzej
More informationOverview. A brief from
A brief from Dec 2017 Getty Images What Are Compounded Drugs, and How Can They Be Kept Safe? Drug Quality and Security Act plays key role in important but potentially high-risk aspect of health care Overview
More informationProduct Questionnaire
Product Questionnaire Let us help you find the SOLUTION for your product needs This product questionnaire has been designed to help you initiate a successful transfer of your product/process to an appropriate
More informationHardyVal TM CSP RANDOM TEST KIT
HardyVal TM CSP RANDOM TEST KIT Cat. no. HVR1 Random Test Kit 5 tests/kit INTENDED USE Each kit contains: Tryptic Soy Broth, Double Strength (DS), 12ml Syringe, 5.2ml Whirl-Pak Bag Results Log Sheet 5
More informationCombination Products Workshop: CGMP and PMSR Requirements. GMP by the Sea August 28, Mark D. Kramer Regulatory Strategies, Inc.
Combination Products Workshop: CGMP and PMSR Requirements GMP by the Sea August 28, 2017 Mark D. Kramer Regulatory Strategies, Inc. 1 Definition of a Combination Product A combination of a drug, device
More informationPreparing Your Aseptic Processing Facility for an FDA Inspection. Valerie Welter, Director Quality Bayer HealthCare March 10, 2014
Preparing Your Aseptic Processing Facility for an FDA Inspection Valerie Welter, Director Quality Bayer HealthCare March 10, 2014 Agenda Regulatory Requirements Establishing your Approach Aseptic Controls
More informationICH Q8/Q8(R)
Pharmaceutical Quality for the 21 st Century Temple University May 06, 2008 Joseph Famulare, Deputy Director FDA CDER Office of Compliance CDER Office of Compliance and the Critical Path Initiative Since
More informationUSP <797> and Environmental Sampling
USP and Environmental Sampling Participants will be in listen only mode. 9 a.m. (PT) Download the PDF: https://www.emlab.com/m/media/usp797-webinar.pdf Presented by: Michael Berg, Ph.D. Continuing
More informationFDA approval of emergency expanded access use may be requested by telephone, facsimile, or other means of electronic communications.
Guidelines for the Submission of an Expanded Access IND to Permit Diagnosis, Monitoring or Treatment of an Individual Patient with an Investigational Drug or a REMS-restricted, Approved Drug Guidelines:
More informationAnalytical and formulation attributes
Peer reviewed article Analytical and formulation attributes in developing generic sterile injectable liquid and lyophilized drugs (part 1) Arindam Roy ARINDAM ROY 1,2 *, GURMUKH CHANANA 1 *Corresponding
More informationMolecular Imaging: Definition, Overview and Goals
This tutorial will define what is currently considered molecular imaging. It will provide history and an overview, discuss the goals and the advantages of molecular imaging. It will clarify what is and
More informationWhitepaper. High temperature HEPA filtration. Dr.-Ing. Marc Schmidt, Dr.-Ing. Lothar Gail, Hugo Hemel MSc. Preview
High temperature HEPA filtration Air filtration challenges and answers for dry heat sterilization tunnels Whitepaper Preview Dr.-Ing. Marc Schmidt, Dr.-Ing. Lothar Gail, Hugo Hemel MSc. Air filtration
More informationCombination Products at US FDA
Multimodal Therapies for Brain Disorders: Session II Regulatory and Reimbursement Considerations Combination Products at US FDA Patricia Y. Love, MD, MBA Deputy Director Office of Combination Products,
More information2 / 1. SUMMARY public, should be well documented, and should be reviewed on a regular basis to determine whether it continues to meet the operational
1. Summary This Report is concerned with the protection of individuals who may be exposed to radiation emitted by x-ray equipment and both sealed and unsealed radioactive sources in the practice of veterinary
More informationGuidance for Industry
Guidance for Industry ANDAs: Impurities in Drug Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should
More informationReview Validation of aseptic processes for pharmaceuticals
OPEM www.opem.org Oriental Pharmacy and Experimental Medicine 2010 10(4), 231-238 DOI 10.3742/OPEM.2010.10.4.231 Review Validation of aseptic processes for pharmaceuticals Lincy Joseph*, Mathew George
More informationOn-Site GMP Training GMP COMPLIANCE TECHNICAL
PharmaNet On-Site GMP Training GMP COMPLIANCE TECHNICAL 284 E Lake Mead Pkwy Suite C-278 Henderson, NV 89015 Phone: 702-558-0094 Fax: 702-558-0079 www.gmpseminars.com Key to Level of Program Level A: Program
More informationGlossary of Abbreviations
Glossary of Abbreviations ANDA APhA Abbreviated New Drug Application American Pharmaceutical Association API Active Pharmaceutical Ingredient BA/BE Bioavailability/Bioequivalence BE Bioequivalence Bio
More informationA Review on Microdosing: Reduction in Cost & Time
Human Journals Review Article June 2016 Vol.:6, Issue:3 All rights are reserved by Rupali Yevale et al. A Review on Microdosing: Reduction in Cost & Time Keywords: Microdosing, phase 0, LC-MS and AMS ABSTRACT
More informationReplacing Analytical Methods for Release and Stability Testing CBER Perspective
Replacing Analytical Methods for Release and Stability Testing CBER Perspective Presentation at the CMC Strategy Forum January 27, 2014 Lokesh Bhattacharyya Chief, Lab of Analytical Chemistry and Blood
More information"NOT FOR IMPLEMENTATION" GUIDANCE FOR INDUSTRY
"NOT FOR IMPLEMENTATION" GUIDANCE FOR INDUSTRY Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo
More informationCurrent Topics For Sterile Generic Drug Products
Current Topics For Sterile Generic Drug Products Marla Stevens-Riley, Ph.D. Team Leader Division of Microbiology for ANDA Review FDA/CDER GPHA CMC Workshop June 4, 2014 Disclaimer Opinions expressed in
More informationHistory and Update of Chapters 797 and 800
United States Pharmacopeia (USP) History and Update of Chapters 797 and 800 Lisa D. Ashworth, BS Pharm, RPh, FACA 50 th Annual C.E. Seminar Saturday, January 27, 2018, Dallas, Texas Disclaimer The views
More informationCurrent Trends in Sterile Manufacturing. by Sterling Kline, RA Director of Project Development Integrated Project Services (IPS)
Current Trends in Sterile Manufacturing by Sterling Kline, RA Director of Project Development Integrated Project Services (IPS) Executive Summary Drug developers go to great lengths to assure that their
More informationThanks and acknowledgement to Pamela Isaacs for the content and slides in this presentation.
A PRESCRIPTION FOR INFECTION PREVENTION ROUNDING IN THE PHARMACY EVELYN COOK Thanks and acknowledgement to Pamela Isaacs for the content and slides in this presentation. OBJECTIVES: 1. Discuss recent outbreaks
More information