Coming to America: Regulatory Opportunities

Size: px
Start display at page:

Download "Coming to America: Regulatory Opportunities"

Transcription

1 Regulatory Quality Forum October 3 and 10, 2014 Four Points Hotel and Casino, Caguas PR Coming to America: Regulatory Opportunities Business Excellence Consulting, Inc. Phone: eg2 eg3 eg4 eg5 Objectives To point out some findings of our assessments to pharmaceutical companies in Europe who has the intention of distributing their product within USA. Findings based on FDA regulations. 2

2 Slide 2 eg2 eg3 eg4 eg5 Presentaremos observaciones hechas a compaías farmacéuticas de Europa. Son compañías que interesan mercadear su producto a Estados Unidos. Por tanto nuestros ässessments"fueron hechos basandonos en las regulaciones de FDA. Debemos recordar que al no estar bajo las regulaciones de FDA hay observaciones que no se deben penalizar

3 Quality Unit Responsibilities The Quality Unit is not responsible for approving or rejecting lots to the market. This responsibility relies in the General Manager or Production Manager. 3 eg6 Documentation: Procedures Format: Guidelines vs. specific steps Not clear Ambiguous instructions Subject to interpretation/creativity Not followed 4

4 Slide 4 eg6 Errores de documentación fue una situación que observamos a través de todos los documentos.

5 Documentation: Reports Blank spaces Qualification documents Write over Qualification documents Backdating It was no signed at the same time the protocol was executed. Approved by the Quality Unit 5 Method Validation The analytical methods are developed by Analytical Development. This area is not reporting to QA. Personnel do not consider their tasks as part of GMP. 6

6 eg8 Training No awareness of employee training completion. New Employee Orientation: Lack of information Not standardized Not restrictive 7 eg9 eg10 Training Delivery Procedures revisions Evaluations Reading (Lecture) vs. practice vs. classroom 8

7 Slide 7 eg8 Se está implantando sistema computarizado y al momento de entrar datos de adiestramento en el sistema no se garantiza saber cuán adiestrados están los empleados. Nohay manera de saber si los empleados están adiestrados en las últimas revisiones de procedimientos. Slide 8 eg9 eg10 No hay procedimiento de como impartir adiestramiento. Las revisiones no son discutidas con el personal. No se determina cuando un procedimiento debe llevar evaluación

8 eg17 Laboratory System suitability chromatographic analytical methods: no challenge to the efficacy of the column no verification of instrument system suitability performance periodically throughout the chromatographic run Samples, reagents and solutions not properly identified. USP changes 9 Laboratory Instruments qualification: Procedure not clear» Which instruments need to be qualified Primary data» Lack of documentation Change of parameters without Quality Assurance approval eg1 10

9 Slide 9 eg17 problemas de documentación Slide 10 eg1 Durante la ejecución de la Cualificación de Operación (sección 11.2) se cambió el criterio de aceptación de uno de los parámetros. Este cambio se documentó en la sección de comentarios, sin embargo no se consultó al área de Garantía de Calidad previo a la implantación del cambio.

10 eg11 eg12 Stability Pilot lots for registration are being tested by analytical development personnel who do not report to the Quality Unit. Climatic chambers are not properly qualified. 11 Reserve Samples Not all the reserve samples are stored under conditions consistent with product labeling. CFR (3) (b) establishes that An appropriately identified reserve sample of each lot or batch of drug product shall be retained and stored under conditions consistent with product labeling. 12

11 Slide 11 eg11 eg12 Los lotes de registros son analizados porpersonal de desarrollo analítico que no reportan a Quality. Confunden calibración con cualificación

12 Investigations Unclear procedure Follow-up to corrective and preventive actions. QA involvement»classification of deviations»approval or Rejection of product»follow up to due dates 13 Environmental Chemical waste containers were found outside of the waste satellite area. Blisters with and without product were found outside the building. 21 CFR » Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner. 14

13 Environmental Pest control: No insects tramps No proper door seals No insectocuters» CFR , Sanitation Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). 15 eg15 Facilities Cleaning Containers without identification in the hallways Gowning area without identification. Access to gowning area without adequate environmental controls. Dirty hallways. Procedure is not followed.» 21 CFR (a): Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance and proper operations. 16

14 Slide 16 eg15 Existe procedimiento de "gowning"pero no es seguido. Por ejempl, prendas y maquillaje.

15 Incoming of Containers and Closures No representative samples CFR 21, Part 211, Subpart E, Section (b) and Subpart G, Section Containers and Closures» Representative samples of each shipment of each lot shall be collected for testing or examination. Approval/Rejection Based on experience not on specifications» CFR 21 Subpart E section (e) Any lot of such material that does not meet such specifications shall be rejected. 17 Customer Complaints Not handled adequately No formal complaint files Not all complaints are investigated» (2012: 3/138 = 2.17%) (2013: 4/125 =3.2%) Complaints closed by providing replacement product» The goal = contact customer < 24 hrs but without root cause analysis Some investigations performed but not documented. Recalls are avoided: isolated or minimal risk or 18 obvious defect.

16 Change Controls Not established: Document Control: Human dependent processes Research and Development: No documentation to assure repeatability Engineering/Manufacturing: No Engineers available. Technicians/Mechanics make necessary adjustments and changes without considering impact on overall product 19 Change Controls Suppliers No approval/certification process in place No change notification agreement requested for suppliers No consideration of impact of change in suppliers No incoming inspection first order approval based on in process testing 20

17 Thanks!!! 21

PA (Process. Areas) Ex - KPAs

PA (Process. Areas) Ex - KPAs PA (Process Areas) Ex - KPAs CMMI Content: : Representación n etapas Level 5 Optimizing Focus Continuous Process Improvement Process Areas Organizational Innovation and Deployment Causal Analysis and Resolution

More information

Section 3 Definitions Certification Replace the word acabados with terminados as reference is made to food destined to the end user. Inspection same.

Section 3 Definitions Certification Replace the word acabados with terminados as reference is made to food destined to the end user. Inspection same. E Agenda Item 6 CONFERENCE ROOM DOCUMENT CRD 2 February 2002 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON FOOD IMPORT AND EXPORT INSPECTION AND CERTIFICATION SYSTEMS Tenth Session Brisbane,

More information

IntesisBox PA-RC2-xxx-1 SANYO compatibilities

IntesisBox PA-RC2-xxx-1 SANYO compatibilities IntesisBox PA-RC2-xxx-1 SANYO compatibilities In this document the compatible SANYO models with the following IntesisBox RC2 interfaces are listed: / En éste documento se listan los modelos SANYO compatibles

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

Basic Understanding of Good Manufacturing Practices Requirements and Execution. Minda Chiang Hong Kong Society for Quality Jan 2006

Basic Understanding of Good Manufacturing Practices Requirements and Execution. Minda Chiang Hong Kong Society for Quality Jan 2006 Basic Understanding of Good Manufacturing Practices Requirements and Execution Minda Chiang Hong Kong Society for Quality Jan 2006 1 Outline 1 To know why GMP 2 To know what GMP is 3 To know how to comply

More information

Annex 7 Guidelines on pre-approval inspections

Annex 7 Guidelines on pre-approval inspections World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the

More information

I. PURPOSE This SOP describes policies, procedures, and record keeping requirements for all documents subject to change control.

I. PURPOSE This SOP describes policies, procedures, and record keeping requirements for all documents subject to change control. SOP Number: SOP -001 Page 1 of 5 4/18/2013 Effective I. PURPOSE This SOP describes policies, procedures, and record keeping requirements for all documents subject to change control. II. SCOPE All SOP s

More information

NSF Dietary Supplement

NSF Dietary Supplement NSF Dietary Supplement SOP Template Book A guide to achieving and maintaining compliance to 21 CFR 111: Dietary Supplement Good Manufacturing Practices 2 Contents How to Use...4 About NSF Dietary Supplements...5

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

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

Manejo Basico del Servidor de Aplicaciones WebSphere Application Server 6.0

Manejo Basico del Servidor de Aplicaciones WebSphere Application Server 6.0 Manejo Basico del Servidor de Aplicaciones WebSphere Application Server 6.0 Ing. Juan Alfonso Salvia Arquitecto de Aplicaciones IBM Uruguay Slide 2 of 45 Slide 3 of 45 Instalacion Basica del Server La

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

LINIO COLOMBIA. Starting-Up & Leading E-Commerce. www.linio.com.co. Luca Ranaldi, CEO. Pedro Freire, VP Marketing and Business Development

LINIO COLOMBIA. Starting-Up & Leading E-Commerce. www.linio.com.co. Luca Ranaldi, CEO. Pedro Freire, VP Marketing and Business Development LINIO COLOMBIA Starting-Up & Leading E-Commerce Luca Ranaldi, CEO Pedro Freire, VP Marketing and Business Development 22 de Agosto 2013 www.linio.com.co QUÉ ES LINIO? Linio es la tienda online #1 en Colombia

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

MANUAFACTURERS AND WHOLESALERS CHAPTER TABLE OF CONTENTS

MANUAFACTURERS AND WHOLESALERS CHAPTER TABLE OF CONTENTS MANUAFACTURERS AND WHOLESALERS CHAPTER 1140-9 (Rule 1140-9-.05, continued) RULES OF THE TENNESSEE BOARD OF PHARMACY Formatted CHAPTER 1140-9 MANUFACTURERS AND WHOLESALERS/DISTRIBUTORS TABLE OF CONTENTS

More information

FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005)

FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) Dr.R.MANAVALAN, M.Pharm., Ph.D. Professor and Research Director, Department of Pharmaceutics,

More information

SUBCHAPTER A. AUTOMOBILE INSURANCE DIVISION 3. MISCELLANEOUS INTERPRETATIONS 28 TAC 5.204

SUBCHAPTER A. AUTOMOBILE INSURANCE DIVISION 3. MISCELLANEOUS INTERPRETATIONS 28 TAC 5.204 Part I. Texas Department of Insurance Page 1 of 10 SUBCHAPTER A. AUTOMOBILE INSURANCE DIVISION 3. MISCELLANEOUS INTERPRETATIONS 28 TAC 5.204 1. INTRODUCTION. The commissioner of insurance adopts amendments

More information

Versión precedente* Lista productos disponibles** Disponible desde el June 1, 2013

Versión precedente* Lista productos disponibles** Disponible desde el June 1, 2013 Versión precedente* Lista productos disponibles** Disponible desde el June 1, 2013 Las solicitudes de licencias de versión anterior sólo están disponibles para los productos enumerados en este documento.

More information

FOOD SAFETY AT-A-GLANCE

FOOD SAFETY AT-A-GLANCE TOPICS Introduction Scope of Business HACCP Program Product Quality Assurance Requirements Product Investigation and Analysis Product Recall & Food Safety Alerts Electronic Databases Food Compliant Investigation

More information

Memorial Health Care System Catholic Health Initiatives Financial Assistance Application Form

Memorial Health Care System Catholic Health Initiatives Financial Assistance Application Form B Please note - Memorial Hospital may access external validation resources to assist in determining whether a full application for assistance is required. Financial Assistance Application 1) Patient Name

More information

WIN TIPS #1. Cómo asegurar el éxito de tu startup

WIN TIPS #1. Cómo asegurar el éxito de tu startup WIN TIPS #1 Cómo asegurar el éxito de tu startup AUTORES: Magdalena Peyroux is la actual CMO de GanaClientes.com. Cuenta con una dilatada experiencia como inbound marketer y ha dirigido las operaciones

More information

PROCEDIMIENTOPARALAGENERACIÓNDEMODELOS3DPARAMÉTRICOSA PARTIRDEMALLASOBTENIDASPORRELEVAMIENTOCONLÁSERESCÁNER

PROCEDIMIENTOPARALAGENERACIÓNDEMODELOS3DPARAMÉTRICOSA PARTIRDEMALLASOBTENIDASPORRELEVAMIENTOCONLÁSERESCÁNER PROCEDIMIENTOPARALAGENERACIÓNDEMODELOS3DPARAMÉTRICOSA PARTIRDEMALLASOBTENIDASPORRELEVAMIENTOCONLÁSERESCÁNER Lopresti,LauraA.;Lara, Marianela;Gavino,Sergio;Fuertes,LauraL.;Defranco,GabrielH. UnidaddeInvestigación,DesaroloyTransferencia-GrupodeIngenieríaGráficaAplicada

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

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

DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION

DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION 1 US FDA Form 483: A Case Study DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION DEVELOPED BY FRAN RABE 2 Introduction This case study is intended to extract portions of information

More information

PATIENT HEALTH QUESTIONNAIRE PHQ-9 FOR DEPRESSION

PATIENT HEALTH QUESTIONNAIRE PHQ-9 FOR DEPRESSION PATIENT HEALTH QUESTIONNAIRE PHQ- FOR DEPRESSION USING PHQ- DIAGNOSIS AND SCORE FOR INITIAL TREATMENT SELECTION A depression diagnosis that warrants treatment or treatment change, needs at least one of

More information

Para ser considerado para obtener un espacio para vender y ser incluido a nuestro sistema de datos, por favor envíenos la siguiente información:

Para ser considerado para obtener un espacio para vender y ser incluido a nuestro sistema de datos, por favor envíenos la siguiente información: Vendor Information Latin Food & Music Family Festival: Saturday, October 3, 2015 To be considered for vendor space and be added to our database, please send all of the following: Information about your

More information

BtoB MKT Trends. El Escenario Online. Luciana Sario. Gerente de Marketing IDC Latin America 2009 IDC W W W. I D C. C O M / G M S 1

BtoB MKT Trends. El Escenario Online. Luciana Sario. Gerente de Marketing IDC Latin America 2009 IDC W W W. I D C. C O M / G M S 1 BtoB MKT Trends El Escenario Online Luciana Sario Gerente de Marketing IDC Latin America 2009 IDC W W W. I D C. C O M / G M S 1 Audio Test Estamos haciendo un Audio Test y estoy hablando en este momento

More information

Raw Gulf Oysters: Labeling, Written Warnings and Additional Requirements.

Raw Gulf Oysters: Labeling, Written Warnings and Additional Requirements. Title 17. Public Health Division 1. State Department of Health Services Chapter 5. Sanitation (Environmental) Subchapter 2. Foods and Drugs Group 1. Rules and Regulations Article 10.5. Raw Oysters 13675.

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

Comments on Draft OECD/IOPS Good Practices on Pension Fund s Use of Alternative Investments and Derivatives

Comments on Draft OECD/IOPS Good Practices on Pension Fund s Use of Alternative Investments and Derivatives Comments on Draft OECD/IOPS Good Practices on Pension Fund s Use of Alternative Investments and Derivatives This document includes comments from various FIAP members, belonging to different countries.

More information

Verbos modales. In this class we look at modal verbs, which can be a tricky feature of English grammar.

Verbos modales. In this class we look at modal verbs, which can be a tricky feature of English grammar. Verbos modales In this class we look at modal verbs, which can be a tricky feature of English grammar. We use Modal verbs in English to show: Probability,Possibility, Capability, Permission, ObligaCon,

More information

HACCP. What is HACCP? What is HACCP? Sometimes referred to as. Hazard Analysis and Critical Control Point system

HACCP. What is HACCP? What is HACCP? Sometimes referred to as. Hazard Analysis and Critical Control Point system HACCP What is HACCP? Hazard Analysis and Critical Control Point system Sometimes referred to as Hazard Analysis and Critical Control Points Hazard Analysis of Critical Control Points (incorrect) What is

More information

Environmental Policy (English Version)

Environmental Policy (English Version) Example #1 Environmental Policy (English Version) ABC Farms commits to meet all environmental rules and regulations in the swine industry and to strive to protect our environment through sound management

More information

SUBCHAPTER A. AUTOMOBILE INSURANCE DIVISION 3. MISCELLANEOUS INTERPRETATIONS 28 TAC 5.204

SUBCHAPTER A. AUTOMOBILE INSURANCE DIVISION 3. MISCELLANEOUS INTERPRETATIONS 28 TAC 5.204 Part I. Texas Department of Insurance Page 1 of 11 SUBCHAPTER A. AUTOMOBILE INSURANCE DIVISION 3. MISCELLANEOUS INTERPRETATIONS 28 TAC 5.204 1. INTRODUCTION. The Texas Department of Insurance proposes

More information

Como sabemos que lo funcional y lo estético son importantes para ti, te ofrecemos diferentes acabados y colores.

Como sabemos que lo funcional y lo estético son importantes para ti, te ofrecemos diferentes acabados y colores. A En Rejiplas fabricamos y comercializamos organizadores y soluciones de espacio para el hogar. Hacemos realidad tus proyectos e ideas optimizando todos los ambientes. Nuestros herrajes y soluciones están

More information

N A T I O N A L M I S S I N G P E R S O N S P R O G R A M DNA

N A T I O N A L M I S S I N G P E R S O N S P R O G R A M DNA University of North Texas Center for Human Identification Family Reference Sample Evidence Registration Form Investigating Agency Information Investigating Agency: Agency Case No.: Address: ORI No.: NCIC

More information

Chapter 10 Physical Development from One to Three

Chapter 10 Physical Development from One to Three Chapter 10 Chapter 10 Physical Development from One to Three Physical Development from One to Three Contents Section 10.1 Growth and Development from One to Three Section 10.2 Caring for Children from

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

Regulatory Submission: Applying GLP in Surgical Efficacy Studies

Regulatory Submission: Applying GLP in Surgical Efficacy Studies Regulatory Submission: Applying GLP in Surgical Efficacy Studies Curtis Schondelmeyer, DVM Director Preclinical Veterinary Services and Efficacy and Surgical Research Services Welcome to Toxikon 2 CONFIDENTIAL

More information

Ernie McCullough, Ph.D.

Ernie McCullough, Ph.D. Ernie McCullough, Ph.D. Q & A What are you? ARE YOU A STORAGE FACILITIES? ARE YOU TRANSPORTATION?? ARE YOU LOGISTICS? ARE YOU IN THE FOOD BUSINESS? Federal Laws Federal Food, Drug, and Cosmetic Act Enacted

More information

Pharmaceutical Wholesaler Site Inspection Checklist

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

More information

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

Commercial Invoice. Terms and Conditions of Delivery and Payment (incoterms)

Commercial Invoice. Terms and Conditions of Delivery and Payment (incoterms) SELLER/SHIPPER (Name, Full Address, Country) Commercial Invoice Invoice Date and Number Customer Order Number CONSIGNEE (Name, Full Address, Country) Tax Identification Number (EIN) Other References Buyer

More information

Level 2 Spanish, 2012

Level 2 Spanish, 2012 91148 911480 2SUPERVISOR S Level 2 Spanish, 2012 91148 Demonstrate understanding of a variety of spoken Spanish texts on familiar matters 2.00 pm Tuesday 20 November 2012 Credits: Five Achievement Achievement

More information

Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products

Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Version 1.3 Drug Office, Department of Health. Contents list 1. QUALITY MANAGEMENT... 4 2. PERSONNEL...

More information

Pharmaceutical Quality System Bringing cgmp into the 21 st Century. Granite State 15 March 2012 Theresa McCarthy

Pharmaceutical Quality System Bringing cgmp into the 21 st Century. Granite State 15 March 2012 Theresa McCarthy Pharmaceutical Quality System Bringing cgmp into the 21 st Century Granite State 15 March 2012 Theresa McCarthy Agenda International Conference on Harmonization ICH Q10 Pharmaceutical Quality System Relationship

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

APS ELEMENTARY SCHOOL PLANNING SURVEY

APS ELEMENTARY SCHOOL PLANNING SURVEY ARLINGTON PUBLIC SCHOOLS PLANNING AND EVALUATION OFFICE APS ELEMENTARY SCHOOL PLANNING SURVEY SURVEY PROCESS & DATA SUMMARY PLANNING AND EV ALUATION O FFICE 1426 NORTH Q UINCY STREET A RLINGTON, VA 22207

More information

PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013)

PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) January 2013 RESTRICTED PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) DRAFT FOR COMMENTS Please address any comments on this proposal

More information

Resumen de Entrevista: Asociación de Agentes de Aduana del Puerto de Manzanillo

Resumen de Entrevista: Asociación de Agentes de Aduana del Puerto de Manzanillo Resumen de Entrevista: Asociación de Agentes de Aduana del Puerto de Manzanillo 1. To your knowledge, to what extent do customs brokers run into operative inconveniences when it comes to collecting payment

More information

AP SPANISH LANGUAGE 2011 PRESENTATIONAL WRITING SCORING GUIDELINES

AP SPANISH LANGUAGE 2011 PRESENTATIONAL WRITING SCORING GUIDELINES AP SPANISH LANGUAGE 2011 PRESENTATIONAL WRITING SCORING GUIDELINES SCORE DESCRIPTION TASK COMPLETION TOPIC DEVELOPMENT LANGUAGE USE 5 Demonstrates excellence 4 Demonstrates command 3 Demonstrates competence

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

EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE INFORMATION FILE

EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE INFORMATION FILE EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE INFORMATION FILE TABLE OF CONTENTS Page 1. Document History... 1 2. Introduction... 1 3. Purpose... 2 4. Scope... 2 5. Site Master File... 2

More information

Example of a food company quality

Example of a food company quality Appendix A manual Example of a food company quality Contents Date: 13/03/95 RME-QLMN-OO Page 1 of 3 Section Title ISO 9001 reference 01 In trod uction 02 Purpose 03 Scope 04 Definitions 05 Management responsibility

More information

Auditing as a Component of a Pharmaceutical Quality System

Auditing as a Component of a Pharmaceutical Quality System Auditing as a Component of a Pharmaceutical Quality System Tim Fields Conducting internal audits (or self inspections) and external audits of suppliers and outsourcing operations are key elements of a

More information

Supplier Quality Assurance

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

More information

On-Site GMP Training GMP COMPLIANCE TECHNICAL

On-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 information

Creating Site Specific Training Materials. Background Information. Resources For Translation. Jean Schechtman, RN, BSN, COHN-S, CM

Creating Site Specific Training Materials. Background Information. Resources For Translation. Jean Schechtman, RN, BSN, COHN-S, CM Creating Site Specific Training Materials A Step By Step Demonstration Jean Schechtman, RN, BSN, COHN-S, CM Occupational Heath Nurse Background Information Why translate training information into another

More information

What is the Common Problem that Makes most Biological Databases Hard to Work With, if not Useless to most Biologists?

What is the Common Problem that Makes most Biological Databases Hard to Work With, if not Useless to most Biologists? What is the Common Problem that Makes most Biological Databases Hard to Work With, if not Useless to most Biologists? RUNI VILHELM MRAG Americas, Inc. 110 South Hoover Blvd., Suite 212 Tampa, Florida 33609-2458

More information

ATLANTA INTERNATIONAL PHYSICAL THERAPY, INC.

ATLANTA INTERNATIONAL PHYSICAL THERAPY, INC. .Specwtlfczlkuj Ut Pedlfltric. physical, occ.upflt«>ithl, Speech Therapy sen/tees PATIENT INFORMATION Patient Name (Nombre del paciente] Date of Birth (Fecha de nacimiento] Address (Direccion] City [Cuidad]

More information

[DOCKET NO. 91N-0450] GUIDELINE FOR QUALITY ASSURANCE IN BLOOD ESTABLISHMENTS. July 11, For further information about this document, contact:

[DOCKET NO. 91N-0450] GUIDELINE FOR QUALITY ASSURANCE IN BLOOD ESTABLISHMENTS. July 11, For further information about this document, contact: [DOCKET NO. 91N-0450] GUIDELINE FOR QUALITY ASSURANCE IN BLOOD ESTABLISHMENTS July 11, 1995 For further information about this document, contact: Center for Biologics Evaluation and Research (HFM-635)

More information

AP SPANISH LANGUAGE 2009 PRESENTATIONAL WRITING SCORING GUIDELINES SCORE DESCRIPTION TASK COMPLETION* TOPIC DEVELOPMENT* LANGUAGE USE*

AP SPANISH LANGUAGE 2009 PRESENTATIONAL WRITING SCORING GUIDELINES SCORE DESCRIPTION TASK COMPLETION* TOPIC DEVELOPMENT* LANGUAGE USE* AP SPANISH LANGUAGE 2009 PRESENTATIONAL WRITING SCORING GUIDELINES SCORE DESCRIPTION TASK COMPLETION* TOPIC DEVELOPMENT* LANGUAGE USE* 5 Demonstrates excellence 4 Demonstrates command 3 Demonstrates competence

More information

General Certificate of Education Advanced Level Examination June 2014

General Certificate of Education Advanced Level Examination June 2014 General Certificate of Education Advanced Level Examination June 2014 Spanish Unit 4 Speaking Test Candidate s Material To be conducted by the teacher examiner between 7 March and 15 May 2014 (SPA4T) To

More information

1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System

1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System Page 1 of 8 1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System 2. Application This Standard Operating Procedure applied to the entire Quality Management System as it relevant

More information

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

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

More information

DOCUMENT RESUME ED 318 301 FL 800 119 AUTHOR EDRS PRICE DESCRIPTORS

DOCUMENT RESUME ED 318 301 FL 800 119 AUTHOR EDRS PRICE DESCRIPTORS DOCUMENT RESUME ED 318 301 FL 800 119 AUTHOR Spener, David TITLE Setting an Agenda for Study in Home-Based ESL r.lasses with Native Speakers of Spanish. PUB DATE 90 NOTE 7p. PUB TYPE Guides - Classroom

More information

Attachments A- ACS First Mailing (Initial Package)

Attachments A- ACS First Mailing (Initial Package) Attachments A- ACS First Mailing (Initial Package) Attachment A1 - ACS-13(L) (2015)(5-2015), ACS Introductory Letter Attachment A2 - ACS-34IM(08-08-2013), Internet Response Instruction Card Attachment

More information

REY PERALES MEMORIAL SCHOLARSHIP

REY PERALES MEMORIAL SCHOLARSHIP REY PERALES MEMORIAL SCHOLARSHIP On August 6th, 2007, the National Plasterers Council lost a great friend and respected colleague in REYMONDO Rey PERALES. REYMUNDO "Rey" PERALES was born October 14, 1951

More information

A. Before you read the text, answer the following question: What should a family do before starting to look for a new home?

A. Before you read the text, answer the following question: What should a family do before starting to look for a new home? UNIT 1: A PLAN FOR BUYING English for Real Estate Materials A. Before you read the text, answer the following question: What should a family do before starting to look for a new home? Read the following

More information

Plumbers and Irrigators INSTRUCTIONS -- PLEASE READ CAREFULLY

Plumbers and Irrigators INSTRUCTIONS -- PLEASE READ CAREFULLY Phone:(401)462-8580 Fax: (401)462-8528 www.dlt.ri.gov/profregs Plumbers and Irrigators INSTRUCTIONS -- PLEASE READ CAREFULLY Applications that are incomplete or missing required documents will not be processed

More information

John Burroughs Agcy 14515 Briarhills#216 Houston TX 77077

John Burroughs Agcy 14515 Briarhills#216 Houston TX 77077 John Burroughs Agcy 14515 Briarhills#216 Houston TX 77077 Verify the vehicles and drivers listed on the Policy Declarations. Check the vehicle identification number (VIN) listed on these documents; its

More information

Advanced AMW, Metal INC. Works, Inc.

Advanced AMW, Metal INC. Works, Inc. Advanced AMW, Metal INC. Works, Inc. APPLICATION FOR EMPLOYMENT PERSONAL INFORMATION Name: Last First Middle Date: Social Security #: Phone #: Referred By: All Names Used In The Past: Present Address:

More information

Project AGUA Survey Results

Project AGUA Survey Results Project AGUA Survey Results Project AGUA (Arid Garden Underground Aquifer) This survey was conducted after the AGUA Presentation on August 6, 2015 at the Santa Ana Public Library to analyze the public

More information

To be considered for vendor space and be added to our database, please send all of the following:

To be considered for vendor space and be added to our database, please send all of the following: VENDOR INFORMATION Latin Food & Music Festival 2014 date: Saturday, September 27 To be considered for vendor space and be added to our database, please send all of the following: Information about your

More information

Producing, Storing and Supplying Animal Feeds

Producing, Storing and Supplying Animal Feeds Producing, Storing and Supplying Animal Feeds EC Feed Hygiene Regulation (183/2005) The Feed Hygiene Regulation (EC 183/2005) came into effect on the 1st January 2006. The Regulation applies to businesses

More information

Lista de Condiciones y Reglas

Lista de Condiciones y Reglas EMCS-Sistema de Control de Movimientos de Impuestos Especiales. Lista de Condiciones y Reglas Autor: S.G.A.A. Fecha: 30/06/2009 Versión: 1.2 Revisiones Edi. Rev. Fecha A(*) Páginas 1 0 29/01/2008 Versión

More information

Please note that the print size cannot be smaller than the text in the document.

Please note that the print size cannot be smaller than the text in the document. Clarification for Civil Rights Non-Discrimination Statement There have been several questions about using the short version of the USDA nondiscrimination statement on NSLP and SBP menus. It is acceptable

More information

"How to do"- Document ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE

How to do- Document ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE Cefic/APIC "How to do" Document ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE GDP for APIs: How to do Document Interpretation of the WHO Guideline GOOD TRADE AND DISTRIBUTION PRACTICES FOR PHARMACEUTICAL

More information

Pharmaceutical Quality Systems: US Perspective

Pharmaceutical Quality Systems: US Perspective Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical

More information

Calibration & Preventative Maintenance. Sally Wolfgang Manager, Quality Operations Merck & Co., Inc.

Calibration & Preventative Maintenance. Sally Wolfgang Manager, Quality Operations Merck & Co., Inc. Calibration & Preventative Maintenance Sally Wolfgang Manager, Quality Operations Merck & Co., Inc. Calibration: A comparison of two instruments or measuring devices one of which is a standard of known

More information

GREPECAS Project G3. Implementation of the Quality Management System in AIM units. (Presented by the Secretariat) SUMMARY

GREPECAS Project G3. Implementation of the Quality Management System in AIM units. (Presented by the Secretariat) SUMMARY International Civil Aviation Organization SAM/AIM/7-WP/05 South American Regional Office 05/02/15 Seventh Multilateral Meeting of the SAM Región for the transition from AIS to AIM (SAM/AIM/7) Lima,, 23

More information

Explorando Oportunidades Juntos Juntos

Explorando Oportunidades Juntos Juntos Nelson H. Balido, Chairman and CEO Infocast - Houston November 2014 The Energy Council of the Americas (ECOTA) is the leading bi-national nonprofit organization comprised of public and private entities

More information

UNICEF s Quality Assurance System for procurement of medicines

UNICEF s Quality Assurance System for procurement of medicines UNICEF s Quality Assurance System for procurement of medicines QA Specialist Peter Svarrer Jakobsen Joint UNICEF, UNFPA and WHO Meeting with Manufacturers and Suppliers UN City, Copenhagen 23 September

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

JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS

JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS 1 WHAT IS A SITE MASTER FILE? A Site Master File (SMF) is a document prepared by the manufacturer containing specific

More information

Ask your child what he or she is learning to say in Spanish at school. Encourage your child to act as if he or she is your teacher.

Ask your child what he or she is learning to say in Spanish at school. Encourage your child to act as if he or she is your teacher. Welcome to Descubre el español con Santillana! This year, your child will be learning Spanish by exploring the culture of eight Spanish-speaking countries. Please join us as we travel through each of the

More information

Read the Questions Carefully

Read the Questions Carefully PHT. 463- (Quality Control of Pharmaceutical Dosage Forms) Midterm Exam I Dr. Ibrahim A. Alsarra s Section Part I Read the Questions Carefully TRUE OR FALSE: Indicate whether the statement is true or false

More information

Benedictine College Financial Aid

Benedictine College Financial Aid 2015 2016 Institutional Verification Document V4 Dependent Your 2015 2016 Free Application for Federal Student Aid (FAFSA) was selected for review in a process called verification. The law says that before

More information

Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments:

Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments: Sample SUPPLIER AUDIT REPORT Supplier / Factory Name: Address: Date of Visit: Tel: Fax: Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments: The suppliers signature

More information

ENVIRONMENT: Collaborative Learning Environment

ENVIRONMENT: Collaborative Learning Environment Guía Integrada de Actividades Contexto de la estrategia de aprendizaje a desarrollar en el curso: The activity focuses on the Task Based Language Learning (TBLL). The task is used by the student in order

More information

Safe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified?

Safe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified? Safe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified? Henry Turlington, Ph.D. Director, Quality & Manufacturing Regulatory Affairs American Feed Industry Association

More information

LEARNING MASTERS. Explore the Northeast

LEARNING MASTERS. Explore the Northeast LEARNING MASTERS Explore the Northeast Explore the Northeast BUILD BACKGROUND Reading Expeditions: Language, Literacy & Vocabulary Five Regions Map Use the information on page 4 of Explore the Northeast

More information

240EO031 - Supply Chain Design

240EO031 - Supply Chain Design Coordinating unit: 240 - ETSEIB - Barcelona School of Industrial Engineering Teaching unit: 732 - OE - Department of Management Academic year: Degree: 2015 MASTER'S DEGREE IN MANAGEMENT ENGINEERING (Syllabus

More information

Tax Court of New Jersey

Tax Court of New Jersey Tax Court of New Jersey Real Property Tax Small Claims Case Handbook This Real Property Tax Small Claims handbook was developed as an information guide to assist you in filing an appeal with the Tax Court

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

Polyurea Marking Material Project/ Proyecto de Materiales para Señalización de Poliurea

Polyurea Marking Material Project/ Proyecto de Materiales para Señalización de Poliurea Polyurea Marking Material Project/ Proyecto de Materiales para Señalización de Poliurea Research and Development/ Investigación y Desarrollo Presented to: ICAO Workshop/ Presentado a: Taller de la OACI

More information

Ch. 147 ENVIRONMENTAL SERVICES 28 CHAPTER 147. ENVIRONMENTAL SERVICES GENERAL PROVISIONS ENVIRONMENTAL SERVICES DEPARTMENTS INFECTION CONTROL

Ch. 147 ENVIRONMENTAL SERVICES 28 CHAPTER 147. ENVIRONMENTAL SERVICES GENERAL PROVISIONS ENVIRONMENTAL SERVICES DEPARTMENTS INFECTION CONTROL Ch. 147 ENVIRONMENTAL SERVICES 28 CHAPTER 147. ENVIRONMENTAL SERVICES GENERAL PROVISIONS Sec. 147.1. Principle. 147.2. Maintenance of safety and sanitation. ENVIRONMENTAL SERVICES DEPARTMENTS 147.11. Principle.

More information

COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS

COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS Primer CONTENTS INTRODUCTION...3 QUALITY AND COMPLIANCE IN QUALITY CONTROL LABORATORIES...5 Compliance

More information

LOS ANGELES UNIFIED SCHOOL DISTRICT REFERENCE GUIDE

LOS ANGELES UNIFIED SCHOOL DISTRICT REFERENCE GUIDE TITLE: Environmental Health Advisory Procedures ROUTING All Schools and Offices NUMBER: ISSUER: Robert Laughton, Director Office of Environmental Health and Safety DATE: March 30, 2015 Thelma Meléndez,

More information