FDA/Xavier PharmaLink Conference, March 2015

Size: px
Start display at page:

Download "FDA/Xavier PharmaLink Conference, March 2015"

Transcription

1 Who just walked through my door? Chris Middendorf, FDA/ORA - Cincinnati District

2 Overview o Basic requirements of a Consumer Safety Officer o Commodity specific training o Drug investigator certification process o Examples of 483s 2

3 Consumer Safety Officer (CSO) Common job title at FDA HQ or Field In the field primarily responsible for conducting inspections, sample collections and import review Generalist Specialist 3

4 Consumer Safety Officer General education requirement at least 30 semester hours in sciences biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work Most have a science degree Discipline varies: Biologist, Chemist, Microbiologist, Pharmacist, Biomedical Engineer B.S., M.S. and PhD 4

5 CSO New Hire Training Basic Food and Drug Law must pass written examination Evidence and Development Personal Safety and Interviewing Skills Online modules (food safety, microbiology, ethics, evidence chain of custody, etc.) Bingo Card list of OJT (field exam, import exam, aseptic sample collection, etc.) 5

6 CSO Several inspections with a mentor or as part of a team Typically independent inspections begin with lower risk commodities i.e. feed mills and low risk foods When CSO is comfortable with basic inspections, they are audited on-site of an inspection by their supervisor New Hire Training + Bingo Card + successful audit = Level 1 Investigator Certification 6

7 CSO with Level 1 certification Commodity specific training at national level Blood Banking, Human Tissue Inspection, Low Acid Canned Food, Medical Device and Basic Drug School, etc. Progression to full performance (journeyman) at the GS-12 Level. Increasing complexity of inspections, additional training opportunities, foreign inspections Generalist CSOs at GS-12 level typically focus on 1 or 2 commodities. 7

8 Specific training for Drug CSOs FDA National Courses Systems-Based Drug Inspections Biological Therapeutics Manufacturing Active Pharmaceutical, Pre-Approval and Sterile Drug Inspections Process Analytical Technology (PAT) Biomanufacturing Principles and Processes 4-week course at North Carolina State University BTEC facility (experienced CSOs) 8

9 CSO Specialists (GS-13 Level) Focus on one commodity after several years of experience in a single commodity Biologics, Drug, Food and Medical Devices Number per district is limited based on establishment inventory (2 drug specialists in Cincinnati District) 9

10 Drug Investigator Certification program Level 2 Drug Investigator Certification Requirements: Not mandatory Be a Level 1 Certified Investigator. Complete the required training courses. Currently spend at least 25% of reportable time conducting finished drug product GMP inspections. Submit a district management endorsed application to the Drug Investigator Certification Board. Pass the Level 2 Drug Investigator Performance Audit. 10

11 Drug Investigator Certification program Level 3 Drug Investigator Certification Requirements: Not mandatory Be a Level 1 Certified Investigator Level 2 Drug Investigator Certification Complete the required training courses. Submit a district management endorsed Level 3 application to the Drug Investigator Certification Board. Complete a detail rotation at CDER in Silver Spring (FDA White Oak Campus ), MD and CVM, in Rockville, MD. 11

12 Pharmaceutical Inspectorate Level 3 Certified Drug Investigators who maintain their certification will be members of the Pharmaceutical Inspectorate (PI) The PI will focus almost exclusively on inspecting facilities that use complex manufacturing technologies Certified Drug Investigators (Level 2 & 3) are required to successfully complete 18 hours of continuing education every three (3) years to maintain their Drug Investigator Certification(s). 12

13 The future of CSOs? Possible increased specialization moving away from a generalist CSO to a single commodity specialist role No longer will a CSO inspect a blood bank one week and a medical device the next Even further specialization within a commodity i.e. APIs, Tablets, Lyo, Liquids Dynamic evolving to meet the needs of the Agency 13

14 So what are drug investigators finding during inspections? Materials Audits not performed according to schedule and / or per the firm s SOP Suppliers of critical material i.e API not reevaluated for frequency or level of oversight, after manufacturer rejected incoming material for confirmed OOS for assay Incoming material was OOS and used while change control open to change specification of material 14

15 So what are drug investigators finding during inspections? CTL s Raw data kept in unsecured/unqualified/unvalidated spreadsheet or not retained Electronic audit trail of an HPLC does not match entries in written log book Unjustified deviations of OOS procedure Exceeding time limit for completing investigations 15

16 So what are drug investigators finding during inspections? CMOs Timeliness of investigations (consistently failing to close investigations per SOP) Failing to follow SOPs Complaints F/U with customer, incomplete investigations Manufacturing Cleaning 16

17 So what are drug investigators finding during inspections? CMOs Processing SOP not supported by validation Ex: SOP allows for 2 nd reprocessing step, but process validation did not include a second reprocessing step Sterility test not validated according to actual use (validation tested immediately but in operations, sterility test not performed for at least 30 days after processing) 17

18 So what are drug investigators finding during inspections? Raw material suppliers Did not notify API customers of an OOS Handled beta-lactams in a nondedicated facility Repacked API into a container-closure system other than system used by original mfg, but did not conduct stability study to support expiry 18

19 So what are drug investigators finding during inspections? Raw material suppliers API manufacturer did not validate inhouse test against USP/EU method Supplier ships API cold (2-8 C), per label, but did not validate a shipping method and did not use temp monitors during shipment 19

20 Thank You 20

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

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

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products- authorisations, European Medicines Agency Brussels, EudraLex The Rules Governing Medicinal

More information

tdodds@jeffyuen.com 714 282-1014 Jeff Yuen and Associates, Inc. PO Box 6026 Orange, CA 92863 Terri Dodds CAPT. (RET) TERRI L.

tdodds@jeffyuen.com 714 282-1014 Jeff Yuen and Associates, Inc. PO Box 6026 Orange, CA 92863 Terri Dodds CAPT. (RET) TERRI L. SKILLS/SPECIAL QUALIFICATIONS: Regulatory Expertise: Technical Expertise: CAPT. (RET) TERRI L. DODDS - BSN, RN Former Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals,

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

Guidance for Industry: Starting Material Supplier Management

Guidance for Industry: Starting Material Supplier Management Guidance for Industry: Starting Material Supplier Management Version 1.0 Drug Office Department of Health. Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. Selecting and

More information

GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors

GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors This course is a distance-learning program that will culminate in a Graduate

More information

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

Bachelor of Science in Pharmaceutical Sciences (BSPS) Program Overview and Internship Requirements

Bachelor of Science in Pharmaceutical Sciences (BSPS) Program Overview and Internship Requirements Bachelor of Science in Pharmaceutical Sciences (BSPS) Program Overview and Internship Requirements Pharmaceutical Sciences Applied sciences that underlie the practice of pharmacy the development, manufacture,

More information

Overview of Pre-Approval Inspections

Overview of Pre-Approval Inspections Overview of Pre-Approval Inspections Presented by: Kelli F. Dobilas NWJ-DO Pre-Approval Manager Pre-Approval Drug Inspections What are Pre-Approval Inspections? One of the last reviews of the drug approval

More information

Guidance for Industry. Q10 Pharmaceutical Quality System

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

More information

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

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/sl/ares(2010)1064587 EudraLex The Rules Governing Medicinal Products

More information

Sandoz Private Limited 10/22/15

Sandoz Private Limited 10/22/15 Sandoz Private Limited 10/22/15 Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD 20993 Warning Letter VIA UPS WL: 320-16-01 October 22, 2015

More information

2014 Annual Report on Inspections of Establishments

2014 Annual Report on Inspections of Establishments 2014 Annual Report on Inspections of Establishments Table of Contents Introduction... 2 Data Collection and Definitions... 3 Section 510(h)(6)(A)(i) Number of Domestic and Foreign Establishments Registered

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

Quality Information. Buchs Manufacturing Site

Quality Information. Buchs Manufacturing Site Buchs Manufacturing Site Related Documents Buchs ISO 9001:2008 Certificate Buchs cgmp Certificate Buchs ISO 13485:2012 Certificate Buchs ISO 17025:2005/ ISO Guide 34 Certificate Buchs Management System

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

Interview with a Thought Leader in Analytical Chemistry

Interview with a Thought Leader in Analytical Chemistry Interview with a Thought Leader in Analytical Chemistry Stephen T. Colgan, Ph.D. By Poonam Delvadia Ph.D. Candidate AAPS APQ Student Representative Graduate Student (Biopharmaceutical Analysis), Department

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

Roles & Responsibilities of the Sponsor

Roles & Responsibilities of the Sponsor Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from

More information

The FDA recently announced a significant

The FDA recently announced a significant This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction

More information

Workshop B Control Strategy

Workshop B Control Strategy ICH-GCG ASEAN Workshop B Control Strategy Jean-Louis ROBERT, Ph.D. National Health Laboratory, Luxembourg Chair-person ICH IWG Q8, Q9, Q10 Kuala Lumpur, 26-28 July 2010 International Conference on Harmonisation

More information

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

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

More information

FDA/Centers: your center training contact, who will submit it to the DHRD training officer.

FDA/Centers: your center training contact, who will submit it to the DHRD training officer. DATE: September 9, 2011 FROM: John Shafer Director, Division of Human Resource Development (HFC-60) SUBJECT: COURSE ANNOUNCEMENT Biomanufacturing Principles and Processes Training (DG426, DG427, DG428,

More information

BACHELOR OF SCIENCE IN MICROBIOLOGY

BACHELOR OF SCIENCE IN MICROBIOLOGY BACHELOR OF SCIENCE IN MICROBIOLOGY The goal of the B.S. Microbiology program at Albany College of Pharmacy and Health Sciences is to prepare graduates for employment or advanced study in fields requiring

More information

Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants

Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants Alex D. Kanarek, PhD BioProcess Technology Consultants, Inc. Strategic Institute Quality

More information

Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015

Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 *QP Code of Practice 2008 updated Aug15 Page 1 of 13 Code of Practice for Qualified Persons 1. INTRODUCTION 2.

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

PHARMACEUTICAL TRAINING GUIDELINE

PHARMACEUTICAL TRAINING GUIDELINE PHARMACEUTICAL TRAINING GUIDELINE 5850 Boymel Dr. Suite 1 Fairfield, OH 45014 Tel.: 513.860.3512 Fax: 513.860.3406 www.compliance-insight.com Reorder Item No. 20.020.2 PHARMACEUTICAL TRAINING GUIDELINE

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

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

HACCP: Hazard Analysis Critical Control Points. Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach

HACCP: Hazard Analysis Critical Control Points. Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach HACCP: Hazard Analysis Critical Control Points Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach Information Adapted from: Hazard Analysis and Critical Control Point

More information

Guidance for Industry DRAFT GUIDANCE

Guidance for Industry DRAFT GUIDANCE DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information Guidance for Industry DRAFT GUIDANCE

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP U.S. Department of Health and Human Services Food and Drug Administration Center for Drug

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

Pharmaceutical Quality Management System: Current Concept

Pharmaceutical Quality Management System: Current Concept Pharmaceutical Quality Management System: Current Concept Neetu Dubey 1, *, Himanshu Gupta 3, R.K. Sharma 2, Nitin Dubey 1, Nidhi Dubey 4 1. IPS Academy, Indore, Madhya Pradesh, India. 2. Prestige Institute

More information

There is no Silver Bullet to complying with the US FDA GMPs by Alan Schwartz

There is no Silver Bullet to complying with the US FDA GMPs by Alan Schwartz There is no Silver Bullet to complying with the US FDA GMPs by Alan Schwartz Recently, we participated in a seminar on United States (US) Food and Drug Administration (FDA) regulations to the Hebei Pharmaceutical

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

More information

IMP management at site. Dmitry Semenyuta

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

More information

Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations

Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations Kevin O Donnell PhD Market Compliance Manager, IMB PDA / FDA Conference Pharmaceutical

More information

Request for Quality Metrics Guidance for Industry

Request for Quality Metrics Guidance for Industry Request for Quality Metrics Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be

More information

GMP Training Course Inspections from an industry perspective. 20-21 October 2009 Fiona Routley MHRA Inspector (UK)

GMP Training Course Inspections from an industry perspective. 20-21 October 2009 Fiona Routley MHRA Inspector (UK) GMP Training Course Inspections from an industry perspective 20-21 October 2009 Fiona Routley MHRA Inspector (UK) Objective To provide an insight into how arranged inspections are prepared and managed.

More information

Preparing for an FDA Pre-Approval Inspection (PAI)

Preparing for an FDA Pre-Approval Inspection (PAI) Preparing for an FDA Pre-Approval Inspection (PAI) Jorge Torres CMQ/OE, CQE, CQA July, 2007 1 Agenda Introduction Understanding the PAI Experience: What to Expect Inspection Management Plan Preparing for

More information

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 038-1 26 March 2012 AIDE-MEMOIRE ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PIC/S March 2012 Reproduction

More information

Microbiology and Auditing. Don Singer

Microbiology and Auditing. Don Singer Microbiology and Auditing Don Singer ASQ Northeast Pharmaceutical GMP/Quality Conference 2011 Through the eyes of a Microbiologist Microbiology Audit = Inspection / Investigation Systematic Auditing Planning

More information

POST-MASTER S CERTIFICATES in ADVANCED QUALITY ASSURANCE or REGULATORY AFFAIRS

POST-MASTER S CERTIFICATES in ADVANCED QUALITY ASSURANCE or REGULATORY AFFAIRS Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034 Phone: 267.468.8560 Fax: 267.468.8565 POST-MASTER S CERTIFICATES in ADVANCED QUALITY ASSURANCE or REGULATORY

More information

ICH Q7 GMP for Active Pharmaceutical Ingredients

ICH Q7 GMP for Active Pharmaceutical Ingredients National University of Singapore Academy of GxP Excellence (NUSAGE) and PharmEng Technology Presents ICH Q7 GMP for Active Pharmaceutical Ingredients Part of the Pharmaceutical Biotechnology Training Courses

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

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL

More information

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE DRAFT CONSENSUS GUIDELINE GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL

More information

School of Pharmacy TEMPLE UNIVERSITY

School of Pharmacy TEMPLE UNIVERSITY School of Pharmacy TEMPLE UNIVERSITY Regulatory Affairs and Quality Assurance Graduate Program Te mple Unive rsity School of Pharmacy Re gulatory Affairs and Quality Assurance Graduate Program 4 25 Comme

More information

UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP)

UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP) UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP) Nutrition Supplier Meeting, June 30, 2015 Dimitris Catsoulacos Quality Assurance Specialist PRESENTATION OVERVIEW Quality

More information

International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation

International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation Ludwig Huber, Ph.D. ludwig_huber@labcompliance.com Overview GMP requirements for Quality Control laboratories

More information

Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy

Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy Global Pharma Sourcing Conference December 6-7, 2011 Philadelphia, USA Nigel J. Smart, Ph.D. Smart Consulting

More information

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection U.S. Department of Health and Human Services Food and Drug Administration Office of Regulatory

More information

Public Cord Blood Bank

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

More information

Annex 2. WHO guidelines on quality risk management. 1. Introduction 62. 2. Glossary 67 3. Quality risk management process 70

Annex 2. WHO guidelines on quality risk management. 1. Introduction 62. 2. Glossary 67 3. Quality risk management process 70 Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initiating

More information

How CMOs are Turning Their Training Programs into Market Differentiators

How CMOs are Turning Their Training Programs into Market Differentiators How CMOs are Turning Their Training Programs into Market Differentiators How CMOs are Turning Their Training Programs into Market Differentiators A Contract Manufacturing Organization (CMO) has as much

More information

Regulatory Expectations of Executive Management

Regulatory Expectations of Executive Management Regulatory Expectations of Executive Management Steven Lynn, MS, CMQ/OE Director Office of Manufacturing and Product Quality Office of Compliance CDER/US FDA PDA ICH Q10 Executive Management Workshop PDA

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

Comprehensive Sample Management Solutions

Comprehensive Sample Management Solutions Comprehensive Sample Management Solutions Discover the Hidden Value in Your Sample Assets solutions consulting sample storage sample bioprocessing onsite/offsite operations management logistics/relocation

More information

ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients questions and answers

ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients questions and answers 23 July 2015 EMA/CHMP/ICH/468930/2015 Committee of Human Medicinal Products ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients questions and answers Step 5 Transmission

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

Corden Pharma Latina S.p.A. 5/20/16

Corden Pharma Latina S.p.A. 5/20/16 Corden Pharma Latina S.p.A. 5/20/16 Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD 20993 Via UPS Warning Letter 320-16-14 Return Receipt Requested

More information

Graduate Studies in Biomedical Sciences

Graduate Studies in Biomedical Sciences Graduate Studies in Biomedical Sciences The graduate program in Biomedical Sciences is designed to provide a multidisciplinary educational and training environment that will prepare them for independent

More information

NC SBI QUALITY ASSURANCE PROGRAM

NC SBI QUALITY ASSURANCE PROGRAM NC SBI QUALITY ASSURANCE PROGRAM for the SBI Reviewed by: Deputy Assistant Director Bill Weis Date: Approved by: Assistant Director Jerry Richardson Date: Originating Unit: SBI Effective Date: July 25,

More information

FDA and the Compounding Pharmacy

FDA and the Compounding Pharmacy FDA and the Compounding Pharmacy Scott Sutton, Ph.D. scott.sutton@microbiol.org 41 Overview of Presentation The Recent Events GCP and GMP Basics the 483 Review H.R. 3204 Outsourcing Facility Preparation

More information

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY SMG 1312.4 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY OFFICE OF REGULATORY AFFAIRS OFFICE OF OPERATIONS

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Q8, Q9, and Q10 Questions and Answers(R4) U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics

More information

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

Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance

More information

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

Standard Operating Procedure Title: Manufacturing Rework Procedure

Standard Operating Procedure Title: Manufacturing Rework Procedure DR BPN RBPN WIP Deviation Report Batch Production Number Reworked Batch Production Number Work in Progress Area PS1 Production Staging Area 1 PS2 Production Staging Area 2 IP Interim Production Staging

More information

Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions

Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions WELCOME Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions Contents: Introduction GMP Audit GMP Audit plan GMP Auditing

More information

Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011

Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011 Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011 World Food Programme Food quality control is necessary to ensure that food aid supplies are safe,

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

2016 > Emcure Pharmaceuticals Limited 3/3/16

2016 > Emcure Pharmaceuticals Limited 3/3/16 Seite 1 von 7 U.S. Food and Drug Administration Protecting and Promoting Your Health Emcure Pharmaceuticals Limited 3/3/16 Department of Health and Human Services Public Health Service Food and Drug Administration

More information

PHARMACEUTICAL QUALITY SYSTEM Q10

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

More information

INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS

INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS About this document This document is a guide to show what the Inspectorate may look for during an inspection visit. It is intended for use by the GPhC

More information

Valentina Gualato, Ph.D. Process Development Scientist

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

More information

Globalization and Its Impact on ORA and Regulated Industry

Globalization and Its Impact on ORA and Regulated Industry Globalization and Its Impact on ORA and Regulated Industry 2013 RAPS: The Regulatory Convergence Global FDA Compliance Update October 1, 2013 December 9, 2013 Boston Waltham, Massachusetts Mutahar Shamsi

More information

Extemporaneously Prepared Early Phase Clinical Trial Materials

Extemporaneously Prepared Early Phase Clinical Trial Materials Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS, RAC Eli Lilly & Co. Regulatory Advisor International Consortium for Innovation & Quality in Pharmaceutical Development

More information

ICH guideline Q10 on pharmaceutical quality system

ICH guideline Q10 on pharmaceutical quality system September 2015 EMA/CHMP/ICH/214732/2007 Committee for Human Medicinal Products Step 5 Transmission to CHMP May 2007 Transmission to interested parties May 2007 Deadline for comments November 2007 Final

More information

FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL

FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7356.002F CHAPTER 56 DRUG QUALITY ASSURANCE SUBJECT: ACTIVE PHARMACEUTICAL INGREDIENT (API) PROCESS INSPECTION Revision Note: Program

More information

PMO Inspection - HACCP Audit Comparison Table

PMO Inspection - HACCP Audit Comparison Table Plant Listing Procedures PMO Inspection - HACCP Audit Comparison Table Inspection Based Milk May be done immediately. Frequency is a minimum of once every 2 years FDA Certified State Rating Officer (SRO)

More information

John Keel, CPA State Auditor. An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy. August 2015 Report No.

John Keel, CPA State Auditor. An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy. August 2015 Report No. John Keel, CPA State Auditor An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy Report No. 15-039 An Audit Report on Inspections of Compounding Pharmacies at the Board of

More information

Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials

Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials 1 2 3 5 August 2011 EMA/INS/GCP/600788/2011 Compliance and Inspection 4 5 6 7 Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials

More information

Graduate School of Pharmaceutical Sciences

Graduate School of Pharmaceutical Sciences Enrollment in FY2013 (October) Enrollment in FY2014 (April) Graduate School of Pharmaceutical Sciences (Master s Degree Program: Pharmaceutical and Life Sciences) (Doctoral Degree Program: Medicinal Sciences)

More information

Aseptic preparations, including TPN, for a limited number of patients

Aseptic preparations, including TPN, for a limited number of patients Aseptic preparations, including TPN, for a limited number of patients Group F (TPN) 1 Objective Presentation of our business case: setting up an aseptic TPN production in the Hilton Pharmacy instead of

More information

Your Global Inspection Solution

Your Global Inspection Solution Your Global Inspection Solution Seafood Inspection Services of the U.S. Department of Commerce NOAA Fisheries Inspection, Grading and Certification Services Third Party Verification Audits Training and

More information

Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations

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

More information

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

NEW CHEMICAL ENTITIES

NEW CHEMICAL ENTITIES NEW CHEMICAL ENTITIES PIONEERING PARTNER FOR PEPTIDES With more than 40 years of expertise in peptide synthesis, a track record in process development, large-scale manufacturing and outstanding product

More information

Q7 Implementation Working Group ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers

Q7 Implementation Working Group ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers Q7 Implementation Working Group ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients and Current version dated 10 June 2015 International Conference on Harmonisation

More information

Guidance for Industry Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

Guidance for Industry Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products Guidance for Industry Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products U.S. Department of Health and Human Services Food and Drug Administration

More information

UDI Regulatory 101. Erin (Fields) Quencer. UDI Conference October 28-29, 2014 Baltimore, MD. October 28, 2014. Regulatory Analyst, FDA

UDI Regulatory 101. Erin (Fields) Quencer. UDI Conference October 28-29, 2014 Baltimore, MD. October 28, 2014. Regulatory Analyst, FDA UDI Regulatory 101 October 28, 2014 Erin (Fields) Quencer Regulatory Analyst, FDA Slide 1 Basic UDI Requirements Device label and device package must bear a UDI, 21 CFR 801.20 Devices intended to be used

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

Corrective and Preventive Actions

Corrective and Preventive Actions Corrective and Preventive Actions A Five Step Approach Topics to Be Covered What is CAPA? Governing authority Five steps to a good CAPA process Where companies have difficulty Example citations Recap What

More information

Author General Management Quality Assurance

Author General Management Quality Assurance Lab Ofichem B.V. Pag.: 1 / 14 Date: 20-01- Version: 02 Status: geldig Contents 1. General... 2 2. Shared Third Party audit program... 3 3. Reassurance absence of Conflict of Interest... 5 4. Contract structure...

More information

Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials. Agenda Topics for Discussion

Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials. Agenda Topics for Discussion Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS Eli Lilly & Co. Principal Consultant - Regulatory PDA/FDA Joint September 20 th, 2011

More information

Quality Metrics An FDA Perspective PDA Dinner and Dialogue. Melissa Seymour VP, Corporate Quality DRAFT

Quality Metrics An FDA Perspective PDA Dinner and Dialogue. Melissa Seymour VP, Corporate Quality DRAFT Quality Metrics An FDA Perspective PDA Dinner and Dialogue Melissa Seymour VP, Corporate Quality DRAFT Agenda How does industry use Metrics? FDA Challenges and Requirements and Use Complexities of Implementation

More information