Risk Based Pre-Approval Inspection
|
|
|
- Kerrie Ball
- 8 years ago
- Views:
Transcription
1 Risk Based Pre-Approval Inspection PQRI-FDA Conference on Advancing Product Quality October 5, 2015 Christine Moore, Ph.D. Acting Director, Office of Process and Facilities FDA/CDER/OPQ
2 Outline Background on Pre-Approval Inspections (PAIs) Risk based decision making related to PAIs Integrated Quality Assessment and PAIs New Inspection Protocol Project (NIPP) Future Directions 2
3 Background on Pre-Approval Inspections (PAIs) 3
4 CDER PAI Program Goal (CPGM ) A pre-approval inspection (PAI) is performed to contribute to FDA s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete. 4
5 Drug PAI Program Coverage Submission types: Original ANDA, NDA, BLA submissions CMC amendments to pending original submissions CMC supplements to approved drug applications Active pharmaceutical ingredients associated with a submission, including those in drug master files (DMFs) Investigational New Drugs (rare) All facilities associated with a submission, domestic and international 5
6 Drug PAI Main Objectives Objective 1: Readiness for Commercial Manufacturing a. Manufacturing and laboratory changes, deviations, and trends adequately evaluated b. Sound and appropriate sampling and testing program c. Contamination controls in place d. Adequate procedures for batch release, change control, investigating failures, deviations, complaints, and adverse events, etc. e. Feasibility of the proposed commercial process Objective 2: Conformance to Application Objective 3: Data Integrity Audit 6
7 Drug PAI Process in Brief CDER determines need for inspection District reviews and concurs with inspection request or waives the inspection Pre-Approval inspection conducted, if warranted Inspection report prepared & reviewed Facility recommendation (Approve, Withhold) 7
8 Risk Based Decisions for Pre-Approval Inspections Determination of the need to for pre-approval inspection Determine areas for inspectional focus Evaluation of risks during inspection Post-inspection evaluation of inspection report Approaches being Developed: Integrated Quality Assessment (IQA) New Inspection Protocol Project (NIPP) 8
9 Risk in Review and Inspection The concept of risk assessment in review and inspection is not new FDA has always used risk as part of regulatory decision making process Efforts are ongoing to standardize and formalize risk evaluation efforts to benefit: Consistent regulatory decision making Best utilization of resources Greatest knowledge retention and sharing 9
10 Risk-Based Inspectional Philosophy Standardized and quantitative approaches, leading to standardized outcomes, related to quality Inspections will include additional site specific information Efficient and effective data gathering Identification of most meaningful risks to quality Decisions made from best relevant information Development of complete picture of facility performance Maximizing the value of each inspection 10
11 Risk-Based Determination of Need for PAI 11
12 Office of Pharmaceutical Quality Immediate Office Acting Director: Janet Woodcock Deputy Director: Lawrence Yu Office of Lifecycle Drug Products Acting Director: Susan Rosencrance Office of New Drug Products Acting Director: Sarah Pope Miksinski Office of Biotech. Products Director: Steven Kozlowski Office of Surveillance Acting Director: Russell Wesdyk Office of Process and Facilities Acting Director: Christine Moore Office of Program and Regulatory Operations Acting Director: Giuseppe Randazzo Office of Policy for Pharm. Quality Acting Director: Ashley Boam Office of Testing and Research Director: Cindy Buhse 12
13 Team-based Integrated Quality Assessment (IQA) The Office of Pharmaceutical Quality (OPQ) will use a team-based Integrated Quality Assessment (IQA) approach to: Maximize each team member s expertise Provide aligned patient-focused and risk-based drug product quality recommendations, inclusive of drug substance, drug product, manufacturing, and facilities 13
14 Integrated Quality Assessment (IQA) Team Applications Technical Lead Regulatory Business Project Manager API ONDP Division of Lifecycle API Product OLDP Product Divisions Microbiology OPF Division of Microbiology Facility OPF Division of Inspectional Assessment Manufacturing, process, controls OPF Division of Process Assessment Dissolution ONDP Division of Biopharm Facility Inspection ORA Investigators District Offices One Quality Voice! 14
15 So, who makes the decision to request an inspection? For applications following the IQA process: The facility reviewer makes the initial assessment of the need for inspection All team members have an opportunity to provide input into the need for inspection Any team member may request participation on the PAI The district office or ORA HQ may modify the request 15
16 Determining Need for Inspection Traditional Approach (CPGM ) Priority Inspection Categories Establishment s first time named in an application First application by an applicant First generic or New Molecular Entity (NME) Narrow content assay range or titrated dosing Substantially different manufacturing process than previously covered API derivation is high risk or significant change in intended use Numerous applications or other changes that may pose significant challenges to a firm s state of control Time since last inspection (a.k.a. 2/3/4 rule) Discretionary Inspection Criteria Significant deficiencies during previous inspections Other situations not previously described District decisions 16
17 Determining the Need for a PAI (Evolving Approach) Facility Risk: Are there manufacturing risks associated with the inspectional history and current operations at this facility that impact the application? Process Risk: What are the manufacturing risks associated with the proposed unit operations in this application? Product Risk: Product Is there limited knowledge about the manufacture of this product? What s the connection between manufacturing with clinical efficacy and patient safety? Process Facility 17 17
18 Communicating Risk 18
19 Communicating Risks to the Inspection Team ORA* is part of the review team from early in the application process Information can be conveyed to the inspection team: Written or verbal communication Directly through IQA reviewer participation Before, during and after inspection Information can be conveyed from the inspection team to the review team in similar ways Communication during inspection to resolve overlapping quality assessment/cgmp issues * NOTE: PAI/PLIs for BLAs are typically led by CDER. 19
20 Risk-Informed Communications Some Best Practices Enhanced interdisciplinary communication throughout the review process Proactive and collaborative conversations with all key players present Include known risks and potential unknown risks to quality Early discussion of potential risk mitigation strategies Recommendations and rationale that are clear to all team members End goal is an integrated product quality assessment (including facility information) that capture important links between product quality and patient outcomes 20 20
21 Seamless integration of review & inspection One Quality Voice! 21
22 Conducting Risk-Based PAIs 22
23 New Inspection Protocol Project (NIPP): Goal To develop a new paradigm for inspections and reports that will advance pharmaceutical quality, including: Standardized approach to inspection Data gathering to inform quality intelligence of sites and products Risk based and rule based process, using expert questions Semi-quantitative scoring to allow for comparisons within and between sites More common inspection report structure Recognition of positive behaviors in cases where facilities exceed basic compliance 23
24 NIPP Organization Schematic New Inspection Protocols Project Steering Committee Pre-Approval Inspection Protocol(s) Subgroup Surveillance Inspection Protocol(s) Subgroup Name TBD For Cause Inspection Protocol(s) Subgroup Observations to inform premarket review decisions Observations on state of quality in a facility to assess quality risk Evidence of cgmp violations to support enforcement
25 PAI NIPP Approach Develop an expert question based template to evaluate quality and associated risk factors Include current PAI program objectives and additional elements related to quality culture Define performance levels, including levels exceeding basic compliance Include analyzable assessments (semi-quantitative scoring) that can track performance Provide an automated or semi-automated production of inspection reports with a common, searchable format (future work)
26 NIPP Expected Outcomes for FDA Maximize the value of time and resources spent on inspections Provide more consistent inspectional coverage and observations Facilitate faster and more consistent review of inspection reports Provide easily analyzable inspection data for trending, within and between sites Produce an assessment of the relative state of quality assurance of the firm being inspected (both positive and negative) Provide a tool to help determine the future inspection frequency based on risk
27 NIPP Expected Outcomes for Industry Provide more consistent inspectional coverage and observations Help provide clarity of expectations for industry practices Provide a benefit (e.g., reduced inspection frequency) for firms with high levels of manufacturing quality and performance Recognize and reward positive behaviors in cases where facilities exceed basic compliance
28 Status of PAI NIPP Phase I evaluation of PAI NIPP is near completion Exploratory phase for feasibility Includes 10 pre-approval inspections, now complete Protocol only used for pilot purposes, and not factored into regulatory decision making or classification Preliminary results Investigators liked it! Great tool for inspection planning Valuable recommendations made for ease of use and content Next steps Collect and compile data related to completed inspections Revise protocols, as appropriate Plan for further piloting in
29 Future Directions for PAIs CDER is committed to using risk based inspectional approaches! Continue cross-training OPQ staff to develop expertise for participating on inspection Further development of risk-based PAI selection model Refine communication between review & inspections Continue development and implementation of the New Inspection Protocol Project 29
30 Acknowledgments CDER: Dave Doleski, Brian Hasselbalch, Theresa Mullin ORA: Susan Laska, Ellen Morrison, Nancy Rolli, Michael Rogers 30
31 Please send questions or comments to:
Pharmaceutical Product Quality, Quality by Design, cgmp, and Quality Metrics
Pharmaceutical Product Quality, Quality by Design, cgmp, and Quality Metrics Lawrence X. Yu, Ph.D. Deputy Director Office of Pharmaceutical Quality Center for Drug Evaluation and Research Food and Drug
OFFICE OF PHARMACEUTICAL QUALITY FDA
OFFICE OF PHARMACEUTICAL QUALITY FDA Pharmaceutical Quality Oversight One Quality Voice Executive Summary The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality
An FDA Perspective on Post- Approval Change Management for PAT and RTRT
An FDA Perspective on Post- Approval Change Management for PAT and RTRT IFPAC 2015 January 26, 2015 Christine M. V. Moore, Ph.D. Acting Director, Process and Facilities FDA/CDER/OPQ Post-Approval Changes
Post-Approval Change Management: Challenges and Opportunities An FDA Perspective
CMC Workshop From Drug Development to Global Supply to Patients April 15-17, 2013, Washington, DC Post-Approval Change Management: Challenges and Opportunities An FDA Perspective Christine M. V. Moore,
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
ICH Q10 - Pharmaceutical Quality System
WCC PDA Dinner Meeting Jan 2012 ICH Q10 - Pharmaceutical Quality System Neil Wilkinson NSF-DBA www.nsf-dba.com ICHQ10.1 WCC PDA Dinner Meeting Jan 2012 Your Presenter Partner at NSF-DBA USA Training, Consultancy,
FOOD AND DRUG LAW JOURNAL Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products
FOOD AND DRUG LAW JOURNAL Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products Enforcement Protecting the Public s Health Through the Application Integrity Policy Paula R. Katz
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
Quality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle
Quality Risk Management 11 November 2011 Galway, Ireland Quality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle Overview Regulatory
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
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
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
FDA Presentation - Society for Clinical Research Sites
FDA Presentation - Society for Clinical Research Sites FDA Presentation - Dr. Richard Moscicki, MD FDA CDER Deputy Director for Clinical Research Sites Faculty Disclosure In compliance with ACCME Guidelines,
Change Management for Virtual Pharmaceutical Firms. Randall Tlachac Molecular and Cellular Therapeutics
Change Management for Virtual Pharmaceutical Firms Randall Tlachac Molecular and Cellular Therapeutics Opening Considerations Managing the kinds of changes encountered by and instituted between two organizations
ectd Digital Handbook Table of Contents
ectd Digital Handbook Table of Contents Introduction by Emily Ethridge, Editor, FDAnews Part 1 Tutorial Section 1.0 ectd Tutorial Table of Contents. This FDA tutorial, consisting of seven PowerPoint presentations,
RISK IDENTIFICATION,ASSESSMENT & MITIGATION TEMPLATE
RISK IDENTIFICATION,ASSESSMENT & MITIGATION Mr. R.M. Gupta (M. Pharm.), is a free lancer consultant for US DMF, COS, ANDA, ACTD, CTD, ectd and other regulatory submissions. guptarmg1952@gmail.com He is
Guidance for Industry
Guidance for Industry Submitting Debarment Certification Statements DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document
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
Quality by Design Concept
3rd Jerusalem Conference on Quality and Pharma Sciences 6-7 June, 2012 QbD in Clinical Research - Where Can QbD Impact Clinical Research Practices? Dr. Yafit Stark Vice President, TEVA Pharmaceutical Industries,
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
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
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
ORACLE CONSULTING GROUP
ORACLE CONSULTING GROUP An Official United States Agent Firm for Foreign Establishments CONSULTING MEMORANDUM: DEALING WITH A MEDICAL DEVICE IN THE U.S. 5398 Golder Ranch Rd., Ste. 1 Tucson, Arizona 85739
QbD Considerations for Analytical Methods - FDA Perspective
QbD Considerations for Analytical Methods - FDA Perspective IFPAC Annual Meeting Baltimore, January 25, 2013 Sharmista Chatterjee, Ph.D. CMC Lead for QbD ONDQA/CDER/FDA Outline Role of analytics in drug
Overview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience
ICH and Singapore Dr Christina Lim Deputy Group Director, Health Product Regulation Group Senior Advisor, International Collaboration Health Sciences Authority Singapore November 2008 Overview Health Science
What is Process Validation?
What is Process Validation? Process Validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process
Quality by Design Approaches to Analytical Methods -- FDA Perspective. Yubing Tang, Ph.D. FDA/CDER/ONDQA AAPS, Washington DC October 25, 2011
Quality by Design Approaches to Analytical Methods -- FDA Perspective Yubing Tang, Ph.D. FDA/CDER/ONDQA AAPS, Washington DC October 25, 2011 1 Outline What is Quality by Design (QbD) Role of Analytical
Guideline on Process Validation
1 2 3 4 29 March 2012 EMA/CHMP/CVMP/QWP/70278/2012-Rev1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) 5 6 Draft Draft Agreed by CHMP /
Health Research Institute. Major shift ahead in how FDA regulates drug quality
Health Research Institute Spotlight February 2016 Major shift ahead in how FDA regulates drug quality Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way
Making SOP Training More Effective
By David Peterson, Director, GMP and Quality Systems, UL EduNeering SOPs are critical to efficient operations, quality control and regulatory compliance. This paper reviews best practices for the Life
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
Overview of Drug Development: the Regulatory Process
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger
Pharmaceutical and Biomedical Due Diligence Checklist
Pharmaceutical and Biomedical Due Diligence Checklist Pharmaceutical and Biomedical Due Diligence Checklist 2 This due diligence checklist template includes many of the key items that are required in M&A
Thomas Hinchliffe, Pharm.D. CDR, U.S. Public Health Service Special Assistant to the Director Office of Generic Drugs Food and Drug Administration
Thomas Hinchliffe, Pharm.D. CDR, U.S. Public Health Service Special Assistant to the Director Office of Generic Drugs Food and Drug Administration Disclaimer & Disclosure Views presented are those of the
Let s skip over the next ten
FOCUS ON... COMPLIANCE Risk-Based Quality Management Systems What Are We Waiting For? by Carol DeSain Let s skip over the next ten years, the changes in FDA policy, politics and leadership; the age-old
Guidance for Industry
Guidance for Industry Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications Comments and suggestions regarding this document should be submitted within 90 days of publication in the
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Institutional Review Board Inspections Additional copies are available from: Office of Good Clinical Practice Office of Special
Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants
Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants September 1999 Table of contents 1. Foreword...... 2 2. Objective...... 3 3. Scope........ 4 4. Potential residues... 5 5. Current
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
Internal Audit Quality Assessment. Presented To: World Intellectual Property Organization
Internal Audit Quality Assessment Presented To: World Intellectual Property Organization April 2014 Table of Contents List of Acronyms 3 Page Executive Summary Opinion as to Conformance to the Standards,
DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.
Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications DRAFT GUIDANCE This guidance document is being distributed
MANAGING THE COMPLEXITIES OF GLOBAL PHARMACEUTICAL SOURCING
DPT Thought Leadership Issue 10 MANAGING THE COMPLEXITIES OF GLOBAL PHARMACEUTICAL SOURCING With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of
Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to
Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to introduce you to the concepts behind risk-based monitoring,
February 2006 Procedural
Guidance for Industry Reports on the Status of Postmarketing Study Commitments Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 U.S. Department of Health and
POLICY AND PROCEDURES OFFICE OF NEW DRUGS. NDAs and BLAs: Communication to Applicants of Planned Review Timelines.
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6010.8 Rev. 1 POLICY AND PROCEDURES OFFICE OF NEW DRUGS NDAs and BLAs: Communication to Applicants of Planned Review Timelines Table of Contents PURPOSE...1
The Advanced Certificate in Performance Audit for International and Public Affairs Management. Workshop Overview
The Advanced Certificate in Performance Audit for International and Public Affairs Management Workshop Overview Performance Audit What is it? We will discuss the principles of performance audit. The session
QUALITY RISK MANAGEMENT (QRM): A REVIEW
Lotlikar et al Journal of Drug Delivery & Therapeutics; 2013, 3(2), 149-154 149 Available online at http://jddtonline.info REVIEW ARTICLE QUALITY RISK MANAGEMENT (QRM): A REVIEW Lotlikar MV Head Corporate
-Drug Master File- Project Management Perspective. CDR Kun Shen, Pharm.D., M.S., BCPS
-Drug Master File- Project Management Perspective CDR Kun Shen, Pharm.D., M.S., BCPS Disclaimer & Disclosure Views presented are those of the speaker and do not reflect official FDA, DHHS or other government
Guidance for Industry
Guidance for Industry Process Validation: General Principles and Practices U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center
RAPS ONLINE UNIVERSITY
RAPS ONLINE UNIVERSITY Practical education and training for business success. For regulatory professionals, there is only one name to know and trust for online education and training RAPS Online University.
Importing pharmaceutical products to China
Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval
CDER Priorities. Janet Woodcock M.D. Director, CDER, FDA
CDER Priorities Janet Woodcock M.D. Director, CDER, FDA CDER has Multiple Important Priorities Diverse stakeholders: all have expectations that their priorities will be addressed (promptly!) Congress has
IVD Regulation Overview. Requirements to Assure Quality & Effectiveness
IVD Regulation Overview Requirements to Assure Quality & Effectiveness CLIAC Jan. 2002 Statutory and Regulatory Requirements Statute: Food, Drug, and Cosmetic Act Food and Drugs Act of 1906 Food and Drug
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)
1 www.imarcresearch.com
Risk Management in Clinical Research: PROCESS DEVELOPMENT & APPLICATION Introduction Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency
Measuring Pharmaceutical Quality through Manufacturing Metrics and Risk-Based Assessment May 1 & 2, 2014
Measuring Pharmaceutical Quality through Manufacturing Metrics and Risk-Based Assessment May 1 & 2, 2014 Meeting Summary Quality assurance and control play an essential role in the pharmaceutical manufacturing
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
ICH Public Meeting. Joseph C. Famulare. October 2, 2006. Acting Deputy Director Office of Compliance CDER / FDA Office of Compliance
ICH Public Meeting October 2, 2006 Joseph C. Famulare Acting Deputy Director Office of Compliance CDER / FDA Office of Compliance The Current State of Pharmaceutical Manufacturing Inability to predict
Board of Directors and Management Oversight
Board of Directors and Management Oversight Examination Procedures Examiners should request/ review records, discuss issues and questions with senior management. With respect to board and senior management
Quality Risk Management Principles and Industry Case Studies
Final Draft Rev. December 28, 2008 Quality Risk Management Principles and Industry Case Studies T. Frank 1, S. Brooks 2, R. Creekmore 3, B. Hasselbalch 4, K. Murray 5, K. Obeng 6, S. Reich 5, E. Sanchez
Consultation process: Career-related Programme
Consultation process: Career-related Programme Guidelines for consultants Global school services June 2012 International Baccalaureate Organization 2012 Page 1 International Baccalaureate International
Internal Control Integrated Framework. May 2013
Internal Control Integrated Framework May 2013 0 Table of Contents COSO & Project Overview Internal Control-Integrated Framework Illustrative Documents Illustrative Tools for Assessing Effectiveness of
Application of Quality Risk Management to Pharmaceutical Operations. Eldon Henson, Vice President, Quality Operations
Application of Quality Risk Management to Pharmaceutical Operations Eldon Henson, Vice President, Quality Operations Key Topics of Discussion Definition of Quality Risk Management (QRM) Overview of PDA
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
POLICY AND PROCEDURES OFFICE OF THE CENTER DIRECTOR. Table of Contents
POLICY AND PROCEDURES OFFICE OF THE CENTER DIRECTOR Tracking of Significant Safety issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issues Table of Contents PURPOSE...1 BACKGROUND...1 POLICY...2
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
Establish Collaborative Strategies to Better Manage a Global Vendor Network Devise a Proper Float Plan
Establish Collaborative Strategies to Better Manage a Global Vendor Network Devise a Proper Float Plan CBI s Biopharmaceutical Forum on Clinical and Commercial Global Supply Chain Excellence Sandy Onorato
FDA Guidance for Industry Update - Process Validation
FDA Guidance Update: Process Validation: General Principles and Practices White Paper FDA Guidance for Industry Update - Process Validation The changing face of Validation; are IQ, OQ and PQ really dead
The Role of the CRO in Effective Risk-Based Monitoring
New Whitepaper The Role of the CRO in Effective Risk-Based Monitoring The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging
Quality Considerations for Breakthrough Therapies-FDA Perspective
Quality Considerations for Breakthrough Therapies-FDA Perspective DIA June 17, 2014 Ramesh K. Sood, Ph.D. Acting Division Director and Angelica Dorantes, Ph.D. xxx ONDQA/OPS/CDER/FDA 1 Background Outline
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
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
Comparison between FDA QSR and ISO 13485
Comparison between FDA QSR and ISO 13485 Most countries in the world including the Europe, for the conformity assessment of medical devices to be used by their countrymen, assess not only whether the product
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
FDA Inspection Observations The FDA 483 and Beyond. Objectives
FDA Inspection Observations The FDA 483 and Beyond Presenter: David L. Chesney Vice President and Practice Lead PAREXEL Consulting, Waltham, MA Dave.chesney@parexel.com Objectives Describe history and
Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions
Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions U.S. Department of Health and Human Services Food and Drug Administration
DNV GL Assessment Checklist ISO 9001:2015
DNV GL Assessment Checklist ISO 9001:2015 Rev 0 - December 2015 4 Context of the Organization No. Question Proc. Ref. Comments 4.1 Understanding the Organization and its context 1 Has the organization
QUALITY BY DESIGN (QBD) : A COMPLETE REVIEW
Review Article QUALITY BY DESIGN (QBD) : A COMPLETE REVIEW Nishendu P. Nadpara*, Rakshit V. Thumar, Vidhi N. Kalola, Parula B. Patel Department of Quality Assurance, S. J. Thakkar Pharmacy College, Opp.
Internal Audit Checklist
Internal Audit Checklist 4.2 Policy Verify required elements Verify management commitment Verify available to the public Verify implementation by tracing links back to policy statement Check review/revisions
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
U.S. Food and Drug Administration
U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA s website for reference purposes only. It was current when produced, but is no longer maintained
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
Combination Products Regulation in the United States
Combination Products Regulation in the United States Presenter: Scott Sardeson RAC US/EU 3M Health Care St. Paul, MN USA 1 Presentation Outline Combination products Definitions and Regulations Jurisdiction
A Quality System Approach to Retrospective Validation of Manufacturing Support Systems William Lodato, P.E.
A Quality System Approach to Retrospective Validation of Manufacturing Support Systems William Lodato, P.E. Abstract As manufacturing support systems (HVAC, Electrical, Compressed Air, Nitrogen, WFI, Control/Monitoring
Baseline Assessments Reveal Opportunities for Hospital Pharmacies
Baseline Assessments Reveal Opportunities for Hospital Pharmacies Key findings around policies and procedures, traceability, compounding and professional responsibilities By Stuart Foxman PAGE 8 ~ WINTER
Quality Management Plan for the Chemistry Manufacturing and Controls Review Process
Quality Management Plan for the Chemistry Manufacturing and Controls Review Process Final, September 13, 2007 Neptune and Company, Inc. Submitted by: Dean Neptune, Kevin Hull, Daniel Michael, Kelly Bennett,
Building the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved
Building the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved A whitepaper by: Opportunities in Micro Quality Control According
Data Standards Strategy. Version: 1.0
Data Standards Strategy Version: 1.0 Document Date: December 5, 2012 Version Number REVISION HISTORY Implemented By Revision Date Description of Change 1.0 CDER DSPB December 5, 2012 Initial Document The
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
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
Update From the Office of Surveillance and Epidemiology
Update From the Office of Surveillance and Epidemiology Gerald J. Dal Pan, MD, MHS Director Office of Surveillance and Epidemiology Center for Drug Evaluation and Research Presentation to FDA-CMS Summit
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
GMP.. A Journey of 1000 miles starts with 1st Step.Induction.
GMP.. A Journey of 1000 miles starts with 1st Step.Induction. 1 Mr. R.M. Gupta (M. Pharm.), is a free lance consultant for US DMF, COS, ANDA, ACTD, CTD, ectd and other regulatory submissions. guptarmg1952@gmail.com
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
Quality Thinking in other Industries. Dominic Parry Inspired Pharma Training. WEB www.inspiredpharma.com GMP BLOG inspiredpharmablog.
Quality Thinking in other Industries Dominic Parry Inspired Pharma Training WEB www.inspiredpharma.com GMP BLOG inspiredpharmablog.com Welcome The traditional focus on quality Quality in the eyes of GMP
The Product Review Life Cycle A Brief Overview
Stat & Quant Mthds Pharm Reg (Spring 2, 2014) Lecture 2,Week 1 1 The review process developed over a 40 year period and has been influenced by 5 Prescription User Fee Act renewals Time frames for review
Development and Validation of In Vitro Diagnostic Tests. YC Lee, Ph.D. CEO
Development and Validation of In Vitro Diagnostic Tests YC Lee, Ph.D. CEO 1 Validation of In Vitro Diagnostic Tests Validated d Diagnostic Test should: Provides test results that identify if positive i
PPSM-34: Incentive and Recognition Award Plans - Managers & Senior Professionals and Professional & Support Staff
PPSM-34: Incentive and Recognition Award Plans - Managers & Senior Professionals and Professional & Support Staff Responsible Officer: Vice President Human Resources Responsible Office: HR - Human Resources
Risk-Based Change Management Using QbD Principles
Risk-Based Change Management Using QbD Principles Lynne Krummen, Ph.D. VP, Global Head, Technical Regulatory Biologics Genentech, a member of the Roche Group CMC Forum 2013 Tokyo, Japan Presentation Outline
ASSET MANAGEMENT. a best practices checklist WHAT IS ASSET MANAGEMENT? HERE IS WHAT YOU WILL LEARN:
ASSET MANAGEMENT a best practices checklist WHAT IS ASSET MANAGEMENT? The Institute of Asset Management defines asset management as the coordinated activity of an organization to realize value from assets.