Process Performance Qualification. Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle

Size: px
Start display at page:

Download "Process Performance Qualification. Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle"

Transcription

1 Process Performance Qualification Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle

2

3 A LIFECYCLE Approach to Process Validation? Lifecycle [ICH Q8(R2)]: All phases in the life of a product from the initial development through marketing until the product s discontinuation. The Validation Group Management

4 Medical Devices Global Harmonization Task Force Process Validation Guidance Reference The Power of Process Validation in Devices Stage 1 Process Development Large Molecule Development: Always an Enhanced Approach Enablers Stage 2 Process Performance Qualification A High Degree of Assurance PPQ: What could possibly go wrong? Stage 3 - Continued Process Verification Leveraging Quality Planning to Achieve High Level of Assurance The views expressed are solely those of the presenter

5 Quality Management Systems Process Validation Guidance Global Harmonization Task Force Medical Devices Referenced in US FDA Guidance for Industry Process Validation: General Principles and Practices January 2011 Similarities between GHTF and FDA Guidances Similar lifecycle approach Use of statistical methods emphasized Robust Quality Systems expected to support the an on-going state of control The product should be designed robustly enough to withstand variations in the manufacturing process process should be capable and stable to assure continued safe products that perform adequately Process Validation is conducted in the context of a system including design and development control, quality assurance, process control and corrective and preventative action.

6 Process Validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process can be practically guaranteed

7 Auto-Injector Components: A High Degree of Assurance Injection Molding (Theoretical Example) 12 cavity mold (each cavity = 1 part) 120 second cycle Tool Qualification: Dimensional Inspection 1 part X 0.5 cycles X 60 minutes = 30 parts cycle minute hour hour Cycle Validation X 3: Parameter range high, midpoint, low 12 parts X 0.5 cycles X 60 minutes = 360 parts cycle minute hour hour

8 A High Degree of Assurance Medical Devices Design and Development Controls Process Validation (IQ, OQ, PQ) Monitor and Control / Revalidation Engineering Focus: Adequate component sample sizes = Heavy reliance on statistical methods Biopharmaceuticals Development Process Qualification Continued Process Verification Life Science Focus: Biological systems, few data = Additional measures where statistics alone may be impractical.

9 High Degree of Assurance at End of Stage 2 Stage 1 Development Stage 2 Process Qualification Stage 3 Continued Process Verification Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product. Stage 1 Which and how much data can be used in conjunction with PPQ data to provide confidence the continuing process control? Commercial Manufacturing How much commercial scale data is needed? Established platform manufacturing - Less? Contract manufacturing organizations More? Quality System - Can the quality system support an ongoing state of control? Has Stage 1 process and product knowledge been integrated into the system?

10 Stage 1: An Enhanced Approach in Biopharma The complexity of the molecule and manufacturing processes have necessitated enhanced approaches to development Process Development and Characterization ICH Q8 Cell Line Qualification ICH Q5A, Q5B, Q5D Clinical Manufacturing ICH Q7 Analytical Characterization ICH Q6B Stability Testing ICH Q5C Comparability ICH Q5E Risk and Criticality Assessments ICH Q9

11 Complex Structure and Properties Quality Attributes can be influenced by Molecular Design, Process Design, and Process Control Physiochemical Properties Structural Heterogeneity Post-translational Modifications 4º 3º 1º 2º Impurities Process Related Impurities Product Related Impurities Product Related Substances Degradation Products Biological Activity Contaminants Higher Order Structure Endogenous Virus Immunochemical Properties Adventitious Agents Since the heterogeneity of these products defines their quality, the degree and profile of this heterogeneity should be characterized to assure lot to lot consistency. ICH Q6B

12 It s all about Control Strategy Specifications / Release testing Clinical Justification most important Criticality, process capability and delectability Analysis and Characterization Process characterization Extended product characterization / comparability Process Control and Monitoring Process and product impurities Raw materials Process monitoring / in-process testing Controls, set points, ranges, hold times Process qualification / validation Process Data Tracking and Trending UNKNOWN Derived from: S. Kozlowski, P Swann / Advanced Drug Delivery Reviews 58 (2006)

13 Communicating a High Degree of Assurance Enablers: Standardized Terminology Knowledge Management Quality Systems Quality Planning

14 Perspective on Standardized Terminology it was recognized from both industry and regulators that there is a need for standardized terminology and use of ICH nomenclature when present. There might be a need for additional terms such as.

15 A-mAb Product Lifecycle

16 A-mAb: Criticality Continuum Quality Attributes In development, the degree of criticality may be assigned to quality attributes based on potential safety and efficacy consequences. Following comprehensive assessments of scientific evidence and risk, quality attributes are ranked according to the degree of criticality. The continuum, as opposed to binary classifications of Critical and Non-Critical, is thought to more accurately reflect complexity of structure-function relationships and the reality that there is some uncertainty in attribute classification High Criticality Quality Attributes Low Criticality Quality Attributes Avoids non-critical terminology which may suggest uncontrolled.

17 Quality Attributes: No NONs ICH Q5E: Quality Attribute A molecular or product characteristic that is selected for its ability to help indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes. Quality Attributes Critical Quality Attributes ICH Q6B: Product-Related Substances Molecular variants of the desired product formed during manufacture and/or storage which are active and have no deleterious effect on the safety and efficacy of the drug product. These variants possess properties comparable to the desired product and are not considered impurities.

18 A-mAb Process Parameter Classification Reproduced/Derived from A-mAb Case study

19 Process Performance Input parameters that must be controlled within a narrow range and are essential for optimum process performance. Key process parameters do not affect critical quality attributes.

20 Standardized Terminology: Control and Criticality If a parameter controllability is high risk even within the design space, can this be considered a state of control?? Should a robust control strategy provide assurance that all process parameters are well-controlled?

21 Process Control Strategy Vocabulary Process Variable Control Can the variable be controlled? No Process Output Process Performance Attribute or Product Quality Attribute Yes Process Input Process Parameter Functional Relationships and Parameter Classification Critical Process Parameters Critical Quality Attributes Key Process Parameters Process Performance Attributes Non-Key Parameters Low Risk of Impact

22 Process Performance Attributes Process performance monitoring: Maintaining a state of control Monitoring of product quality attributes alone incomplete - changes in process performance may represent early warning sign Monitored, tracked, trended in Continued Process Verification Process performance attributes demonstrate inter-batch consistency Production Bioreactor Key Parameter: Osmolality Performance Attribute: Antibody Titer IEX Chromatography Key Parameter: Load Conductivity Performance Attribute: Recovery

23 Documentation and Knowledge Management In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make the program more effective and efficient.

24 Turning Documents into Knowledge Engaging the Quality Unit early can be a wise investment in managing documents and knowledge! QA? Engage the Quality Group to enable knowledge management Comprehensively communicating a high degree of assurance through PPQ reports and in S.2.5 is more likely Ensure knowledge integration into the quality system (ICH Q10)

25 Documentation and Knowledge Management Process Development Product Characterization Pilot Scale Production Robustness Studies Risk Assessment Lifecycle Document Development Reports Analytical Reports Batch Records Qualification Reports FMEA Report Technical Summary

26 PPQ Protocols and Reports: Comprehensive Story PPQ documents as tools to describe a high degree of assurance Provide a comprehensive description of the control strategy. Include non-critical process variables even though only a subset of parameters and attributes will comprise PPQ Describe how the subset of PPQ parameters and attributes demonstrates a state of control Reference appropriate stage 1 data and discuss relevance. PPQ Acceptance Criteria How established and why TELL THE WHOLE STORY / MAKE NO ASSUMPTIONS

27 Stage 2: High Degree of Assurance Qualification of Facilities, Utilities, and Equipment Contamination Control Strategy Facilities Flow and segregation Equipment Preventative Maintenance Procedures Changeover Monitoring Environmental, Process Gas, Water Validation Cleaning and Sterilization Membrane & Resin Lifetime Bioburden & Endotoxin Limits (and on-going monitoring)

28 Qualification of Process Performance: Process Control Strategy Specifications, Acceptance Criteria, Action Limits Product Characterization Release Testing Quality Systems and GMP Stability Testing Raw Materials Analysis In-Process Testing Process Controls and Monitoring

29 PPQ Not Limited to Stage 2 Scaled down predictive, qualified models Viral Spiking Studies (ICH Q5) Stage 1 Process Robustness (ICH Q8) Stage 1 Impurity Clearance (ICH Q8) Stage 1, 2 Chromatography Resin Lifetime Stages 1, 2, 3 Extended Analytical Product Characterization Structure Function Relationships (ICH Q6B) Stage 1 Comparability (ICH Q5E) Stages 1, 2, 3 Real Time (Parametric) Release Viral inactivation and clearance parameters Stage 3 Impurity clearance: DNA, Protein A Stage 3

30 Enhanced Sampling During PPQ Routine Samples Characterization-Demonstrates comparability Impurity Clearance Validates small scale models Protein Stability Qualifies non-microbial hold time Capture Viral Inactivation Filtration Cation Exchange Viral Removal Filtration Anion Exchange Filtration

31 Perspective on Enhanced Sampling We recommend continued monitoring and sampling at the level established during the process qualification stage until sufficient data are available to generate significant variability estimates Enhanced sampling and testing to be discontinued after PPQ: PPQ is fully supportive of the predictive small scale models (impurities: Protein A, DNA) Enhanced sampling to continue: Unexpected results obtained in PPQ Trends suspected in PPQ data Plan for data collected FIO (significant variability estimates): Rationale for continued sampling Plan for evaluation of accumulated data Timeframe or amount of data needed to for decision on continuation.

32 Use of Statistical Methods at End of Stage 2 Likely to rely on means other than statistics alone to achieve a high degree of assurance Often insufficient data to correctly apply traditional statistics. Few clinical batches Limited number of commercial scale batches Statistically based sampling plans not useful for homogeneous bulk pools Achieving a high degree of assurance with limited use of statistics requires clear, comprehensive rationale with references to supporting studies conducted in Stage 1.

33 Quality Planning for Commercial Manufacturing What to Measure, Where to use Statistics Action Limits and Acceptance Criteria Statistical Monitoring Thaw Inoculum Expansion Seed Bioreactors Production Bioreactor Quality Plan / CPV Plan finalized at end of Stage 2. What is to be measured and why, accounting for interactions Statistical methods to be used for data evaluation. Frequency with which data will be evaluated Frequency of Management Review

34 Unexpected Results in PPQ Production Chromatography Operations Drug Substance Bioreactor Titre ( ) Recovery Capture (70-100) Recovery AEX (90-100) Process Performance Attributes Recovery CEX (90-100) Acidic Variants (25-35) Quality Attribute Oxidation (3-10) Aggregate <4% Critical Quality Attributes Pilot * % Pilot % Pilot % Pilot % Pilot % Eng Feed Rate / Volume increased after 1 st PPQ run to to increase titer. What next? PPQ % PPQ % PPQ %

35 Unexpected PPQ Results: High Degree of Assurance in Continued Process Verification a reduced number of batches cannot adequately capture the expected process variability at commercial manufacturing scale. To provide continued assurance that the process remains in a state of control throughout the life of commercial manufacturing, we will create a multivariate statistical partial least squares model (PLS) as part of continued process verification.

36 Appropriate Statistical Methods PLS is more powerful than standard univariate Statistical Process Control (SPC) approaches in that it ensures that the internal correlations among the different variables are also considered. For example if at any given time the titer is lower than expected for the measured viable cell concentration, the PCA model will be able to detect this as a potential out of norm signal even if both parameters are within their respective univariate ranges. Thus, a PLS model can be used to create a fingerprint of the process that detects a larger number of potential shifts, trends and excursions that would not be detected by univariate monitoring tools.

37 Quality System: Alert and Action Limits For those parameters that are not built into this PLS model, additional monitoring such as univariate SPC charts, and other routine process monitoring will be carried out. Because of its utility as a process monitoring tool, the PLS model will also have alert and action limits; and when the process result exceeds the action limit a deviation will be initiated.

38 Quality System and Planning Supports CPV Data Collection and Evaluation Trending and Calculations Change Control System Deviation System Complaint System Continued Facility Maintenance Management Review Feedback Loop Adjust Process Feedback Loop Avoid Surprise Feedback Loop Root Cause Feedback Loop No overreaction Qualification Plan / Schedule

39 The A-mAb Case Study Team Abbott Amgen Eli Lilly Genentech GSK MedImmune Pfizer Acknowledgements

40 Back Up

41 Process: Monoclonal Antibody Production Thaw: Working Cell Bank Inoculum Expansion Seed Bioreactors Production Bioreactor Antibodies Produced Harvest- Centrifugation / Depth Filtration Capture Protein A Viral Inactivation Filtration Cation Exchange Viral Removal Filtration Anion Exchange Filtration

42 Quality Group to Enable the KM Program Pharmaceutical Development Technology Transfer Commercial Manufacturing Discontinuation Investigational products GMP Management Responsibilities Process Performance & Product Quality Monitoring System PQS Corrective Action / Preventive Action (CAPA) System elements Change Management System Management Review Enablers Knowledge Management Quality Risk Management

What to control? CQAs and CPPs

What to control? CQAs and CPPs What to control? CQAs and CPPs Dr. Thomas Stangler On behalf of the European Generic medicines Association Development Strategy & Technology Manager Sandoz Biopharmaceuticals 1 Martin Schiestl Singapore,

More information

Workshop on process validation

Workshop on process validation Workshop on process validation CMC Strategy Forum Europe 2013 EBE Process validation satellite session Pragues, 06/05/2013 Kowid Ho Scope / background Process evaluation/validation of biotechnology derived

More information

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission 1 2 3 25 April 2014 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided

More information

Synopsis: FDA Process Validation Guidance

Synopsis: FDA Process Validation Guidance Synopsis: FDA Process Validation Guidance This synopsis is a comparison of the draft version 2008 and the final version 2011 of the U.S. FDA Guidance Process Validation: General Principles and Practices.

More information

Process Validation: Practical Aspects of the New FDA Guidance

Process Validation: Practical Aspects of the New FDA Guidance Process Validation: Practical Aspects of the New FDA Guidance ISPE Boston Chapter Meeting April 18, 2013 Rusty Morrison Commissioning Agents, Inc. Objectives / Summary What is Process Validation? Regulatory

More information

Manufacturing process of biologics

Manufacturing process of biologics Manufacturing process of biologics K. Ho Afssaps, France 2011 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2011 ICH 1 Disclaimer:

More information

DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Q11

DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Q11 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES

More information

Guidance for Industry

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

More information

ICH Topic Q 5 E Comparability of Biotechnological/Biological Products

ICH Topic Q 5 E Comparability of Biotechnological/Biological Products European Medicines Agency June 2005 CPMP/ICH/5721/03 ICH Topic Q 5 E Comparability of Biotechnological/Biological Products Step 5 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES

More information

Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4)

Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4) INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Quality Implementation Working Group on Q8, Q9 and Q10 & (R4) Current version dated

More information

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/ biological entities)

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/ biological entities) November 2012 EMA/CHMP/ICH/425213/2011 ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/ biological entities) Step 5 Transmission to CHMP May

More information

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4 December 2010 EMA/CHMP/ICH/265145/ Committee for medicinal products for human use (CHMP) ICH guideline Q8, Q9 and Q10 - questions and answers volume 4 Step 5 Transmission to CHMP for information December

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

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 THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION

More information

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission 28 April 2016 EMA/CHMP/BWP/187338/2014 Committee for Medicinal Products for Human Use (CHMP) Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be

More information

Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform

Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform CHAPTER 1: Overview CHAPTER 2: Challenges CHAPTER 3: Purification Methodology CHAPTER 4: Results CHAPTER 5: About Eden Biodesign

More information

What is Process Validation?

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

More information

Validation and Calibration. Definitions and Terminology

Validation and Calibration. Definitions and Terminology Validation and Calibration Definitions and Terminology ACCEPTANCE CRITERIA: The specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an

More information

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) May 2011 EMA/CHMP/ICH/425213/2011 ICH/ Committee for medicinal products for human use (CHMP) ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological

More information

Tutorial on Reference Materials / Standards

Tutorial on Reference Materials / Standards Tutorial on Reference Materials / Standards Co-chaired by: Dieter Schmalzing, Barry Cherney, Nancy Kirschbaum, Juhong Liu, Markus Blümel January 29, 2013 WCBP 2013, Washington, DC Disclaimer This tutorial

More information

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) 22 May 2014 EMA/CHMP/BWP/247713/2012 Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance:

More information

Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps)

Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps) Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps) Anita R. Michael, Pharmaceutical Specialist FDA Office of Regulatory Affairs 1 Process Validation

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

Host cell Protein Clearance and Detection: Critical issues for Biopharmaceutical development

Host cell Protein Clearance and Detection: Critical issues for Biopharmaceutical development Host cell Protein Clearance and Detection: Critical issues for Biopharmaceutical development Protein Quantification workshop, Waters: 13 th November 2012 Vincent Monchois, R&D and Pilot Services Manager,

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Q6B. Current Step 4 version

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Q6B. Current Step 4 version INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE

More information

Multivariate Tools for Modern Pharmaceutical Control FDA Perspective

Multivariate Tools for Modern Pharmaceutical Control FDA Perspective Multivariate Tools for Modern Pharmaceutical Control FDA Perspective IFPAC Annual Meeting 22 January 2013 Christine M. V. Moore, Ph.D. Acting Director ONDQA/CDER/FDA Outline Introduction to Multivariate

More information

Monoclonal Antibody Production: Building the Platform. Andrew Clutterbuck Eden Biodesign Ltd.

Monoclonal Antibody Production: Building the Platform. Andrew Clutterbuck Eden Biodesign Ltd. Monoclonal Antibody Production: Building the Platform Andrew Clutterbuck Eden Biodesign Ltd. Questions Questions are encouraged throughout the presentation and can be asked by using the email address provided

More information

A Risk Assessment of Pre-Licensure Manufacturing Changes

A Risk Assessment of Pre-Licensure Manufacturing Changes A Risk Assessment of Pre-Licensure Manufacturing Changes Patrick G. Swann, Ph.D. Deputy Director Division of Monoclonal Antibodies Office of Biotechnology Products Office of Pharmaceutical Science FDA-CDER

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

LIBRARY GUIDE: Pharmaceutical GMPs

LIBRARY GUIDE: Pharmaceutical GMPs LIBRARY GUIDE: Pharmaceutical GMPs Table of Contents Overview............................................................................ 3 Courses Listed by Functional Area....................................................

More information

Quality and Safety Evaluation of Gene Therapy Products in Japan

Quality and Safety Evaluation of Gene Therapy Products in Japan Quality and Safety Evaluation of Gene Therapy Products in Japan Review Mechanism for Gene Therapy in Japan The review mechanism for gene therapy in Japan was partially amended to simplify the necessary

More information

Expectations for Data to Support Clinical Trial Drugs

Expectations for Data to Support Clinical Trial Drugs Expectations for Data to Support Clinical Trial Drugs Presentation to: APEC Advanced Workshop on Review of Drug Development in Clinical Trials Bangkok Thailand Feb 2-6 2009 Willem Stevens Ph.D., Chief

More information

ICH Q10 Pharmaceutical Quality System (PQS)

ICH Q10 Pharmaceutical Quality System (PQS) ICH Q10 Pharmaceutical Quality System (PQS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Q10 PQS Guideline Background Objectives

More information

Technology Transfer of CMC Activities for MAb Manufacturing. 2010 ge healthcare (www.gelifesciences.com)

Technology Transfer of CMC Activities for MAb Manufacturing. 2010 ge healthcare (www.gelifesciences.com) M a n u f a c t u r i n g OPERATIONS Technology Transfer of CMC Activities for MAb Manufacturing by Patricia Seymour, Susan Dana Jones, Howard L. Levine With combined 2009 revenues estimated to be over

More information

Implementing New USP Chapters for Analytical Method Validation

Implementing New USP Chapters for Analytical Method Validation Implementing New USP Chapters for Analytical Method Validation March 2010 Ludwig Huber Fax.: +49 7243 602 501 E-mail: Ludwig_Huber@labcompliance.com Today s Agenda Handling Method Changes vs. Adjustments

More information

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals MAbLaunch TM is a joint bioproduction platform combining LFB Biomanufacturing (LFB

More information

Analytical Method Validation in Early Drug Development US FDA Perspective

Analytical Method Validation in Early Drug Development US FDA Perspective Analytical Method Validation in Early Drug Development US FDA Perspective Linda Ng, Ph.D. Office of Manufacturing & Product Quality, Office of Compliance Best Practices and Application of GMPs for Small

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

Quality by Design (QbD) Overview

Quality by Design (QbD) Overview Quality by Design (QbD) Overview Gary Warren Director, Haemostasis and Thrombosis R&D October, 2015 CSL Behring Pty Ltd Broadmeadows, Victoria What is Quality by Design (QbD)? QbD is: A Quality System

More information

White paper: FDA Guidance for Industry Update Process Validation

White paper: FDA Guidance for Industry Update Process Validation White paper: FDA Guidance for Industry Update Process Validation In January 2011, the FDA released the final version of its long-awaited update to its Process Validation Guidance for Industry. Since then,

More information

Considerations in Setting Specifications

Considerations in Setting Specifications EBE Concept Paper Considerations in Setting Specifications March 28, 2013 European Biopharmaceutical Enterprises (EBE), a specialised group of EFPIA Leopold Plaza Building Rue du Trône 108 BE-1050 Brussels

More information

Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry

Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry BY GHULAM A. SHABIR Introduction Methods Validation: Establishing documented evidence that provides a high

More information

[ABOUT THE AUTHOR. FDA Lifecycle Approach to Process Validation What, Why, and How? PQ Forum. Paul L. Pluta]

[ABOUT THE AUTHOR. FDA Lifecycle Approach to Process Validation What, Why, and How? PQ Forum. Paul L. Pluta] Paul L. Pluta] FDA Lifecycle Approach to Process Validation What, Why, and How? Paul L. Pluta PQ Forum provides a mechanism for validation practitioners to share information about Stage 2 process qualification

More information

Contamination Control Cleaning Validation

Contamination Control Cleaning Validation Contamination Control Cleaning Validation Ravi Hattarki Manufacturing Projects Manager CSL Behring, Australia 17 th June 2014 1 This presentation will discuss Cleaning Potential Contaminants Regulatory

More information

Guideline on Process Validation

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 /

More information

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals MAbLaunch TM is a joint bioproduction platform combining LFB Biomanufacturing (LFB

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

Change Control. A Key Element of a Quality System

Change Control. A Key Element of a Quality System IVT 9 th Annual Conference Change Control Change Control A Key Element of a Quality System Jerry Lanese Ph.D. CMC The Lanese Group, Inc. 2011 The Lanese Group 1 Will discuss A Quality System What is it

More information

PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY

PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY Guideline Title Production and Quality Control of Medicinal Products derived by recombinant DNA Technology Legislative

More information

ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Step 5

ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Step 5 European Medicines Agency September 1999 CPMP/ICH/365/96 ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Step 5 NOTE FOR GUIDANCE ON SPECIFICATIONS:

More information

Luca Romagnoli, Ph.D. Business Development Manager

Luca Romagnoli, Ph.D. Business Development Manager Modelli innovativi di produzione per lo sviluppo di un processo altamente qualitativo di farmaci biologici Luca Romagnoli, Ph.D. Business Development Manager BIOLOGICAL DRUGS - SOURCES Monoclonal antibodies

More information

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 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

More information

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 *

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 * PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PS/INF 11/2015 1 April 2015 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 * * Entry into force:

More information

The Effective Management of Change Across the ICHQ10 Lifecycle

The Effective Management of Change Across the ICHQ10 Lifecycle The Effective Management of Change Across the ICHQ10 Lifecycle Rob Hughes AstraZeneca 1 Change Management the guide This presentation will: describe a structured approach to change across the ICH Q10 lifecycle

More information

PROPOSAL FOR REVISION OF THE SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES: VALIDATION, APPENDIX 7: NON-STERILE PROCESS VALIDATION

PROPOSAL FOR REVISION OF THE SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES: VALIDATION, APPENDIX 7: NON-STERILE PROCESS VALIDATION April 2013 RESTRICTED 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 PROPOSAL FOR REVISION OF THE SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES:

More information

Pharmaceutical Manufacturing for New Drugs Current Status and Vision for the Future

Pharmaceutical Manufacturing for New Drugs Current Status and Vision for the Future Pharmaceutical Manufacturing for New Drugs Current Status and Vision for the Future NIPTE Research Conference on The Future of Pharmaceutical Manufacturing June 18, 2013 Elaine Morefield, Ph.D. Deputy

More information

ICH Q 10 Pharmaceutical Quality System PQS DIA China Annual Meeting, May 2010

ICH Q 10 Pharmaceutical Quality System PQS DIA China Annual Meeting, May 2010 ICH Q 10 Pharmaceutical Quality System PQS DIA China Annual Meeting, May 2010 Joseph C. Famulare Head of External Relations and Collaboration Pharma Global Technical Operations Global Quality, F. Hoffmann-La

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

Biotechpharma company profile

Biotechpharma company profile Biotechpharma company profile October 2013 1 History 2004 Biotechpharma UAB established as a proteomic research company in Vilnius, Lithuania 2005 Company became a member of UK s Northway group, investing

More information

Guideline on process validation for finished products - information and data to be provided in regulatory submissions

Guideline on process validation for finished products - information and data to be provided in regulatory submissions 21 November 2016 EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on process validation

More information

CONTINUED PROCESS VERIFICATION: AN INDUSTRY POSITION PAPER WITH EXAMPLE PLAN

CONTINUED PROCESS VERIFICATION: AN INDUSTRY POSITION PAPER WITH EXAMPLE PLAN CONTINUED PROCESS VERIFICATION: AN INDUSTRY POSITION PAPER WITH EXAMPLE PLAN CPV PAPER LEADING CONTRIBUTORS The following people were lead contributors to the content of this document, writing sections,

More information

2008 USPC Official 12/1/07-4/30/08 General Chapters: <1225> VALIDATION OF C...Page 1 of 10

2008 USPC Official 12/1/07-4/30/08 General Chapters: <1225> VALIDATION OF C...Page 1 of 10 2008 USPC Official 12/1/07-4/30/08 General Chapters: VALIDATION OF C...Page 1 of 10 1225 VALIDATION OF COMPENDIAL PROCEDURES Test procedures for assessment of the quality levels of pharmaceutical

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

Workshop A Design Space (DS)

Workshop A Design Space (DS) Implementation of ICH Q8, Q9, Q10 Workshop A Design Space (DS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Disclaimer The information

More information

Analytical Method Validation for Assay, Related substances & Dissolution. N A Y A N K S H A T R I 1 8 / 0 1 /

Analytical Method Validation for Assay, Related substances & Dissolution. N A Y A N K S H A T R I 1 8 / 0 1 / Analytical Method Validation for Assay, Related substances & Dissolution. N A Y A N K S H A T R I 1 8 / 0 1 / 2 0 1 3 Definitions The objective of validation of an analytical procedure is to demonstrate

More information

Guideline for Technology Transfer

Guideline for Technology Transfer Guideline for Technology Transfer 1. Preface 1.1 Background According to the revised Japanese Pharmaceutical Affairs Law in July 2003, the manufacturing approval system has been replaced with the manufacturing

More information

How Long Does it Take to Manufacture Plasmid under GMP?

How Long Does it Take to Manufacture Plasmid under GMP? How Long Does it Take to Manufacture Plasmid under GMP? Manufacturing plasmid under GMP generally takes four to nine months, depending upon your project s specific requirements. You may be wondering, Why

More information

FDA Guidance for Industry Update - Process Validation

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

More information

Workshop on process validation

Workshop on process validation Workshop on process validation General concepts on process validation Kowid Ho Scope / background Process evaluation/validation of biotechnology derived proteins used as active substance in the manufacture

More information

Working Party on Control of Medicines and Inspections. Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice

Working Party on Control of Medicines and Inspections. Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 Working Party on Control

More information

VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1)

VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1) INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY

More information

Manufacturing Process Qualification & Validation. Naren Patel. Naren Patel 1

Manufacturing Process Qualification & Validation. Naren Patel. Naren Patel 1 Manufacturing Process Qualification & Validation Naren Patel Naren Patel 1 Manufacturing Process Qualification & Validation Tutorial Why to Validate What to Validate Program How to Perform successful Validation

More information

State of Control Over the Lifecycle and Process Validation (New and Legacy Products)

State of Control Over the Lifecycle and Process Validation (New and Legacy Products) State of Control Over the Lifecycle and Process Validation (New and Legacy Products) Grace McNally Branch Chief (acting), Regulatory Policy and Collaboration Branch FDA/CDER/Office of Compliance ICH Q10,

More information

Quality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle

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

More information

Analytical Method Validation

Analytical Method Validation Analytical Method Validation A. Es-haghi Ph.D. Dept. of Physico chemistry vaccine and serum research institute a.eshaghi@rvsri.ir http://www.rvsri.ir/ Introduction Test procedures for assessment of the

More information

Deviation Handling and Quality Risk Management

Deviation Handling and Quality Risk Management Deviation Handling and Quality Risk Management A note for guidance for the manufacture of prequalified vaccines for supply to United Nations agencies July, 2013 Vaccine Quality and Regulations (VQR), Essential

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

Viral Safety of Plasma-Derived Products

Viral Safety of Plasma-Derived Products Viral Safety of Plasma-Derived Products SLIDE 1 This presentation will cover viral validation studies for plasma-derived products. FDA requires that the manufacturing process for biopharmaceutical products

More information

Guidance for Industry. Monoclonal Antibodies Used as Reagents in Drug Manufacturing

Guidance for Industry. Monoclonal Antibodies Used as Reagents in Drug Manufacturing Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing U.S. Department of Health and Human Services Food and Drug Administration enter for Drug Evaluation and Research (DER)

More information

Change Management in Development White Paper

Change Management in Development White Paper Change Management in Development White Paper Introduction/Background In 2008, the International Conference on Harmonization published the ICH tripartite guideline titled, Pharmaceutical Quality System:

More information

Biopharmaceutical Process Evaluated for Viral Clearance

Biopharmaceutical Process Evaluated for Viral Clearance Authored by S. Steve Zhou, Ph.D. Microbac Laboratories, Inc., Microbiotest Division The purpose of Viral Clearance evaluation is to assess the capability of a manufacturing production process to inactivate

More information

Risk-Based Validation and Requalification of Processes & Equipment. Nancy Tomoney Associate Validation Manager QPharma Inc.

Risk-Based Validation and Requalification of Processes & Equipment. Nancy Tomoney Associate Validation Manager QPharma Inc. Risk-Based Validation and Requalification of Processes & Equipment Nancy Tomoney Associate Validation Manager QPharma Inc. Order of Operations US Predicate law always comes first US Guidances Other non

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION The European Agency for the Evaluation of Medicinal Products London, 1 March 2001 CPMP/QWP/848/96 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)

More information

QUALITY RISK MANAGEMENT (QRM): A REVIEW

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

More information

Changes to an Approved Product

Changes to an Approved Product Changes to an Approved Product Chemistry, Manufacturing and Controls By Khandan Baradaran, PhD and Peggy Berry, MBA, RAC It is a huge achievement for any company to obtain licensing rights to an approved

More information

A Parker domnick hunter White Paper. Controlling bioburden within biopharmaceutical manufacturing processes

A Parker domnick hunter White Paper. Controlling bioburden within biopharmaceutical manufacturing processes A Parker domnick hunter White Paper Controlling bioburden within biopharmaceutical manufacturing processes Table of contents Introduction...3 Minimizing bioburden in biopharmaceutical manufacturing processes...4

More information

A Stability Program for the Distribution of Drug Products

A Stability Program for the Distribution of Drug Products A Stability Program for the Distribution of Drug Products Teresa I. Lucas*, Rafik H. Bishara, and Robert H. Seevers Drug products must be transported in a manner that ensures products will be maintained

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

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

CHMP/BWP DRAFT GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS

CHMP/BWP DRAFT GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS European Medicines Agency Evaluation of Medicines for Human Use London, 28 June 2006 Doc. Ref. EMEA/CHMP/BWP/398498/2005-corr CHMP/BWP DRAFT GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL

More information

The manufacturing process of bio-drugs

The manufacturing process of bio-drugs The manufacturing process of bio-drugs The manufacture of biopharmaceutical substances : - Most highly regulated and rigorously controlled processes To gain a manufacturing license, the producer should

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

Corrective and Preventive Action Background & Examples Presented by:

Corrective and Preventive Action Background & Examples Presented by: Corrective and Preventive Action Background & Examples Presented by: Kimberly Lewandowski-Walker Food and Drug Administration Division of Domestic Field Investigations Office of Regulatory Affairs Overview

More information

Risk-Based Change Management Using QbD Principles

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

More information

Process Validation of Macugen API:

Process Validation of Macugen API: Process Validation of Macugen API: An Exercise in Submission Preparation and Inspection Readiness Patrick Giljum Head of Operations BioTechLogic, Inc. Today s Discussion Process Validation of Macugen API:

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

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

Process Validation for Medical Devices

Process Validation for Medical Devices Process Validation for Medical Devices Dan O Leary CBA, CQE, CRE, CSSBB, CIRM, LLC 603-209-0600 OmbuEnterprises@msn.com Copyright 2010 by, LLC Process Validation for Medical Devices 1 Instructor Introduction

More information

IMPURITIES IN NEW DRUG PRODUCTS

IMPURITIES IN NEW DRUG PRODUCTS INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current

More information

Product Quality Management

Product Quality Management Product Quality Management Deborah Baly, Ph.D Sr. Director, Commercial Product Quality Management, GNE/ROCHE 1 Presentation Outline: Product Quality Management Regulatory landscape and need for integrated

More information