PDA: A Global. Association. Matrix Approach to Media Fills. (c) 2012 Catalent Pharma Solutions. All rights reserved.
|
|
- Tobias Brown
- 6 years ago
- Views:
Transcription
1 PDA: A Global Matrix Approach to Media Fills Association (c) 2012 Catalent Pharma Solutions. All rights reserved.
2 Overview Guidance Overview Matrix Introduction Why Matrix Media Fills Sample Matrix New Products & Technologies Biologics Scheduling Media Fills Handling Matrix Media Fill Failures Innovations in Media Fills 2
3 Guidance Criteria PDA EU FDA Selection Numer of runs & frequency Matrix Considerations Incubation temperature Qualification of staff 3 runs for validation routine 2/Y Risk assessment to set worst case No worst case, run at extremes of range C for 14 days Initial, then once per year 3 runs per shift for validation routine 2/Y Evaluate # of interventions C for 7 days followed by C for 7 days Frequency not specified 3 runs for validation routine 2/Y Evaluate: range of speeds # of interventions # of personnel C for 14 days. If 2, incubate at lower temp first Initial, then once per year 3 runs per shift for validation routine 2/Y Use largest container with widest mouth at slowest speed and smallest vial with highest speed C for 7 days followed by C for 7days Frequency not specified 3
4 Reason for matrix approach Most efficient compliant method validating multiple products. Best Coverage: Microbiological assurance confirmed by worst case conditions Systematic program including Risk Assessment forces examination of all products and parameters annually Cost Savings: Raw Materials Indirect Costs - Testing, Disposal and Clean up Equipment costs: purchase and maintenance of incubators Additional capacity for production Manpower costs 4
5 Introduction of matrix Risk Assessment utilized to determine critical to sterility parameters Risk Assessment determines worst case value for critical to sterility parameters (fill duration, # of interventions, # of personnel, # of aseptic connections during set up) Where a worst case value can not be justified, the extreme values of the range are used to bracket the parameter (container size, closure size, fill speed) 5
6 Example of a simple matrix Filling Line is used for 3 products Reduction of 67 % Conventional Media Fill Schedule Product Vial Size Closure Size fill speed staff Fill time interventions # of Media Fills Initial Routine 1 2mL 13mm 200/min 3 6 hour /yr 2 5mL 20mm 150/min 2 7 hour /yr 3 20mL 20mm 120/min 2 8 hour /yr Matrix Media Fill Schedule # of Media Fill required without using matrix approach 9 6/yr 1 2mL 13mm 200/min 3 8 hour /yr 2 20mL 20mm 120/min 3 8 hour /yr # of Media Fill required using matrix approach 6 2/yr 6
7 New products & technologies New Product is compared to current limits to determine fit If not covered within existing limits a separate media fill is required If covered by the existing limits, the Generic Validation Protocol is updated to include new products placement, including risk assessment completion & documentation New Technology requires risk assessment; most likely will require separate matrix 7
8 Biological products Due to Biologics process variability, no single / standard process set up is possible It may be more practical to validate the various segments of the process individually The frequency of revalidation should relate to the process of regular, commercial production determined to use worst case conditions 8
9 Schedule Foundation of schedule is worst case condition Program schedule reviewed and approved annually Schedule updates for new products deployed through risk assessments and implemented via change control Different approaches can be used : Alternate to cover each end of the set limits Randomize to cover each end of the set limits and mid level processes 9
10 Media fill myths Fence determination via brackets can lead to larger potentially impacted population Frequency of media fills within the fence actually increases, reducing risk to any specific product MYTHS Human error failures impact larger population TRUTH Human failures should always be treated with full CAPA, fence should be the same in matrix vs. non-matrix program 10
11 Innovations in media fill Irradiated Dehydrated Media Eliminates Bioburden & Mycoplasma risks Reduced contamination risk Cold Filterable Media Filterability Formulation in facility Safety (no hot WFI) Mimics process No pre-use sterilizing/testing Vegetable Based Media Optimized performance with non-animal origin Eliminates TSE risk Available irradiated Available with color indicator Possible recovery for anaerobic media fill use CONSIDERATIONS Validation in use (eg. Recovery vs. TSB) Maturity in use Fit for purpose for individual needs Supplier Qualification 11
12 Summary Matrix approach to Media Fills A systemic, risk based method utilizing worst case conditions Meets guidance requirements for equipment and validation of staff Provides coverage at lowest cost A structured way to review new products, and technologies; including Biologics 12
13 Thank you for your attention Acknowledgements - Catalent Pharma Solutions: G. Delestrait, D. Diels-Vandepoel, E. Hoppenbrouwers, H. Jeffreys, J. Krewer, K. Schmidt, J. Spiers 13
Hot Topics in Drug Product Process Validation: A Reviewer s Perspective
Hot Topics in Drug Product Process Validation: A Reviewer s Perspective Colleen Thomas, Ph.D. Quality Assessment Lead (Acting) FDA/CDER/OPQ/OPF Division of Microbiology Assessment CASSS CMC Strategy Forum
More informationReview Validation of aseptic processes for pharmaceuticals
OPEM www.opem.org Oriental Pharmacy and Experimental Medicine 2010 10(4), 231-238 DOI 10.3742/OPEM.2010.10.4.231 Review Validation of aseptic processes for pharmaceuticals Lincy Joseph*, Mathew George
More informationAnnex A2. Guidance on Process Validation Scheme for Aseptically Processed Products
Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products 1 Table of content 1 PURPOSE... 3 2 SCOPE... 3 3 GENERAL INFORMATION... 3 4 INFORMATION NEEDED FOR ASEPTIC PROCESSES VALIDATION...
More informationOverview and Introduction Annex 1 Revision
Overview and Introduction Annex 1 Revision Paul Moody, Inspector Pharmig Current Hot Topics in Pharmaceutical Microbiology, Dublin May 30 th, 2018 Scope History Process of Revision Rationale for Revision
More informationPROCESS VALIDATION ROCHAPON WACHAROTAYANKUN, PH.D.
Basic GMP Requirement PROCESS VALIDATION ROCHAPON WACHAROTAYANKUN, PH.D. Topic Process validation What and Why? Principle of process validation Manufacturing process validation Aseptic process validation
More informationRisk based approaches for a sterility assurance application review: a microbiologist s perspective Dr. Yeissa Chabrier Roselló
Risk based approaches for a sterility assurance application review: a microbiologist s perspective Dr. Yeissa Chabrier Roselló Product Quality Microbiologist Division of Microbiology Assessment Office
More informationCleaning validation of cleanrooms and preparation equipments
Cleaning validation of cleanrooms and preparation equipments Dr Farshid SADEGHIPOUR Head of production Central Pharmacy, Geneva University Hospitals EAHP Foundation Seminar: Patient Safety; More About
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union
Ref. Ares(2014)968036-28/03/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy Brussels, 28 March 2014 EudraLex
More informationFDA s Guidance for Industry
Sterile Drug Products Produced by Aseptic Processing - CGMPs Midwest FDC Conference November 4 2005 Susan Bruederle, Investigator FDA / ORA / Central Region Chicago District / Hinsdale IL FDA s Guidance
More informationThe Life Cycle Approach to Cleaning Validation
The Life Cycle Approach to Cleaning Validation Presented by: Elizabeth Rivera Technical Services Manager August 2015 Orlando, FL OMICS Conference 1/ Agenda Background Process Design Process Qualification
More informationOverview of a sterility assurance program for PET drugs
Coalition for PET Drug Approval Radiopharmaceutical Sciences Council Overview of a sterility assurance program for PET drugs Eric Webster, PETNET Solutions Disclosures Employee of PETNET Solutions, a Siemens
More informationEudraLex. Part I1 Chapter 6: Quality Control
EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines tofor Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part I1 Chapter 6: Quality
More informationMedia Fill A Process Simution. Presented By Shikha Chauhan
Media Fill A Process Simution Presented By Shikha Chauhan 21 CFR 211.113 Validation of Aseptic Processing and Sterilization Process Simulation / Media Fill Filtration Efficacy Sterilization of Equipment,
More informationOverview of Inspection Issues with Legacy Products
Overview of Inspection Issues with Legacy Products Presented by Simone E. Pitts Consumer Safety Officer, USFDA Team Biologics simone.pitts@fda.hhs.gov Objective To provide some examples of recent inspectional
More informationComplaints Investigations Root Cause Analysis
Complaints Investigations Root Cause Analysis Dr. Ademola Daramola International Relations Specialist Drugs US FDA India Office New Delhi February 22nd 2018 Information presented in this presentation does
More informationSterilizing and Bioburden Filter Risk Assessment in Vaccine Processes as part of QRM
Sterilizing and Bioburden Filter Risk Assessment in Vaccine Processes as part of QRM DCVMN Workshop, Hyderabad, 4-8 April 2016 G. Somasundaram Associate Director - Technology Management Overview Key Regulatory
More informationAseptic Processing Current Issues & Trends
Aseptic Processing Current Issues & Trends 1 Introduction Richard M. Johnson Member, PDA for 20+ years President & CEO since 2009 Ladies and Gentlemen, I am happy to be here with you. Senhoras e Senhores,
More informationPoints to Consider for Aseptic Processing Part 2 May 2016
Points to Consider for Aseptic Processing Part 2 May 2016 PDA Points to Consider for Aseptic Processing Part 2 Task Force Authors and Contributors Harold Baseman, Valsource, LLC (Co-Chair) Gabriele Gori,
More informationPurpose of GMP. The Underlying Principle. Why Media Fill? :Session 2: Qualification/validation of aseptic techniques dos and don ts 7/5/2014
:Session 2: Qualification/validation of aseptic techniques dos and don ts Mr. Sanjay Singh, Sr. Vice President Aurobindo Pharma Aseptic Processing Workshop: July 2014; Indore Purpose of GMP Generally,
More informationPreparing Your Aseptic Processing Facility for an FDA Inspection. Valerie Welter, Director Quality Bayer HealthCare March 10, 2014
Preparing Your Aseptic Processing Facility for an FDA Inspection Valerie Welter, Director Quality Bayer HealthCare March 10, 2014 Agenda Regulatory Requirements Establishing your Approach Aseptic Controls
More informationBFS IOA BFS Training 2018 Kunming Qualification and Validation of a BFS-Installation including CIP/SIP
Qualification and Validation of a BFS-Installation including CIP/SIP Presented by Christoph Bohn and Stefan Kiesel Director Rommelag Pharma Service Senior Manager Rommelag Pharma Service Coyright BFS IOA
More informationSystems-Based Inspections for Cleaning Validation
Systems-Based Inspections for Cleaning Validation FDA DG 230 July 21, 2014 Rockville, MD Destin A. LeBlanc Cleaning Validation Technologies www.cleaningvalidation.com 1 Cleaning Definition: The process
More informationAseptic Process Validation
Aseptic Process Validation IMB GMP Information Seminar 27 th September 2012 Gerard Sheridan, Inspector Date Insert on Master Slide Slide 1 Overview Guidance Best Practices Common Deficiencies Slide 2 Aseptic
More informationOverview of Regulatory Requirements for API and Formulations
Overview of Regulatory Requirements for API and Formulations Sangeeta Sardesai 4-Dec-2010 Definition - Regulatory Requirement The restrictions, licenses, and laws applicable to a product or business, imposed
More informationAseptic Processing Practices and Process Validation of Aseptic Operators
Aseptic Processing Practices and Process Validation of Aseptic Operators CBE Pty Ltd This training program is copyright to CBE Pty Ltd and may not be modified, reproduced, sold, loaned, hired or traded
More informationEUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 25 October 2005 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU
More informationDr. Sheelpriya walde Professor Gurunanak college of pharmacy, Nagpur
Dr. Sheelpriya walde Professor Gurunanak college of pharmacy, Nagpur GMP ( Adopted in 1975 ) In India Good manufacturing practices are the practices required in order to conform to guidelines recommended
More informationValidation Considerations for New Technologies:
Validation Considerations for New Technologies: A Practitioner s Perspective 2012 GMA Science Forum Hormel Foods Originate, don t imitate George A. Hormel 1860-1946 So, What s New? Marketing just heard
More informationValidation of Pharmaceutical Manufacturing Process Focus: APIs.
Validation of Pharmaceutical Manufacturing Process Focus: APIs Validations: Regulatory History (US FDA) Sterilisation 1977 Aseptic processing 1979 Water Systems 1981 Non-sterile Mfg Process 1987 Revised
More informationAdvancements on implementation of single use technology in vaccine manufacturing
Advancements on implementation of single use technology in vaccine manufacturing October 25 th, 2013 DCVMN Meeting Rio de Janeiro, Brazil Outline Overview of single use products Applications of single
More informationRegulatory Aspects of Cleaning and Cleaning Validation. Larry Greenstein Quality Operations, Quality Unit, Bio-Technology General, Ltd.
Regulatory Aspects of Cleaning and Cleaning Validation Larry Greenstein Quality Operations, Quality Unit, Bio-Technology General, Ltd. 28 June 2017 Why clean? Pharmaceutical production equipment is cleaned
More informationEnvironmental Monitoring Performance Qualification (EMPQ) Risk Assessment
Environmental Monitoring Performance Qualification (EMPQ) Risk Assessment Agenda Risk Assessment Environmental Monitoring Performance Qualification Risk Identification Risk Analysis Risk Analysis Exercise
More informationMicrobiology Testing: USP requirements for Sterile and Nonsterile Preparations Webinar Q&A
USP Antimicrobial Effectiveness Testing Microbiology Testing: Webinar Q&A 1. If a base ingredient is designed for the purpose of compounding a specific type of preparation does this forgo the necessity
More informationMICROBIOLOGY AND NEW TECHNOLOGY HOW TECHNOLOGY CAN IMPACT ON MICROBIOLOGICAL CONTROL
MICROBIOLOGY AND NEW TECHNOLOGY HOW TECHNOLOGY CAN IMPACT ON MICROBIOLOGICAL CONTROL DISCUSSION AREAS HOW MICROBIOLOGY NEEDS TO CHANGE TO MEET FUTURE DEMANDS AND PRODUCTION SYSTEMS MICROBIOLOGY AND PAT
More informationGuidance for Industry
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products Center for Drug Evaluation and Research (CDER) Center
More informationMedia Fill Evaluations in Cellular Therapy Product Manufacturing: Three Possible Approaches. Doug Padley Mayo Clinic
Media Fill Evaluations in Cellular Therapy Product Manufacturing: Three Possible Approaches Doug Padley Mayo Clinic Media Fill Evaluation Process Simulation Manufacturing process performed using microbiological
More informationContents. Contents (13) 1 Production (23)
1 Production (23) 1.A Sanitation (27) 1.A.1 Organisational prerequisites (27) 1.A.2 Sources of contamination (28) 1.A.3 Responsibilities and implementation (29) 1.B Personnel hygiene (31) 1.B.1 Clothing
More informationIntroduction and Background
Introduction and Background Validation of Biotech Facilities Pacific Biotech Alliance Robert J. Mackey Pacific Biotech Alliance is an established consulting firm in the Pacific Northwest that specializes
More informationCurriculum Vitae. SENIOR VICE PRESIDENT JAMES P. KULLA Mobile Phone:
Curriculum Vitae SENIOR VICE PRESIDENT JAMES P. KULLA Mobile Phone: 240.413.3350 Summary of Qualifications Jim has been active in the medical products industry since 1967. Jim founded a company in 1980
More informationLIFE TESTING FOR DEVICE COMBINATION PRODUCTS
LIFE TESTING FOR DEVICE COMBINATION PRODUCTS APPROACHES AND CHALLENGES FOR INTEGRATING DEVICES INTO A COMPREHENSIVE STABILITY PROGRAM CLINT JUDD PRINCIPAL QUALITY ENGINEER INTRODUCTION What is shelf life
More informationGuidelines for Process Validation of Pharmaceutical Dosage Forms
Guidelines for Process Validation of Pharmaceutical Dosage Forms Version 2.1 Date issued 21/02/2010 Date of implementation 21/05/2010 31 August 2010 Page 1 of 20 Guidelines for Process Validation of Pharmaceutical
More informationThe Parenteral Drug Association
C O N F E R E N C E R E P O R T Equipment Cleaning Microbial Control Issues By Destin A. LeBlanc, M.A. Cleaning Validation Technologies Validation: The Parenteral Drug Association (PDA) spring conference
More informationYour Goal is Zero Positives. So is Ours.
Data Sheet Your Goal is Zero Positives. So is Ours. Granulated and Ready-to-Use Culture Media for Secure Media Fill Trials When performing media fill trials, you shouldn t have to worry about culture media
More informationUpdates Regarding the OGD Division of Microbiology & ANDA Sterility Assurance Review Dr. Lynne A. Ensor
Updates Regarding the OGD Division of Microbiology & ANDA Sterility Assurance Review Dr. Lynne A. Ensor U.S. Food & Drug Administration Center for Drug Evaluation & Research Office of Pharmaceutical Science/Office
More informationMicrobiological Cleaning Method Validation
Microbiological Cleaning Method Validation The purpose of cleaning procedures should never be to reduce bioburden to an acceptable level! Fergus O Connell QA Manager Eurofins ams Laboratories www.eurofins.com
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. This document is for consultation until 11 December 2015
Ref. Ares(2015)3808922-15/09/2015 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Medicinal Products Quality, Safety and Efficacy Brussels, [date] This document is for consultation until 11
More informationGuidance for Industry Process Validation: General Principles and Practices; A Contract Manufacturing Organization's Approach
May -3, 202 Javits Center New York, NY Guidance for Industry Process Validation: General Principles and Practices; A Contract Manufacturing Organization's Approach Sandra Lueken Director of Quality Baxter
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE- GENERAL Health systems and products Medicinal products quality, safety and efficacy 18 February 2010 EMA/CHMP/BWP/534898/2008 Committee for Medicinal
More informationSecure. Tested. Certified.
Secure. Tested. Certified. We solve problems with confidence and creativity. Monitoring Products for Dry Heat DRY Steam-Formaldehyde Chlorine Dioxide FORM CL02 NAMSA s Sterilization Products Division manufactures
More informationCleaning Validation Systems CIP COP Manual How to get to Validation
Cleaning Validation Systems CIP COP Manual How to get to Validation First: Know and Understand the Soils and Residues You Must Clean Virus 3 Raw Meat and Prions 4 Formalin Sodium Citrate Sucrose Triton
More informationSterilization - validation, qualification requirements. Sterilization - Overview
Sterilization - validation, qualification requirements Dawn Tavalsky 1 ISPE Boston Chapter Framingham MA 19Sep2013 Sterilization - Overview Objectives Discuss definition of Sterile Briefly describe sterilization
More informationThe ABCs and Challenges of GMP The American Experience
The ABCs and Challenges of GMP The American Experience The Canadian Association of Nuclear Medicine Toronto, Ontario April 22, 2017 Reiko Oyama, R.Ph., B.C.N.P. Washington University School of Medicine
More informationExtractable and Leachable Challenges From a generic injectable drug development perspective
Extractable and Leachable Challenges From a generic injectable drug development perspective Andrea Redd Director, US Regulatory Affairs Fresenius Kabi November 8, 2017 Disclaimer This presentation contains
More informationRecent USP Updates May, 2013
Recent USP Updates May, 2013 Don Singer GSK Bioburden Control of Non-sterile Drug Substances and Products The chapter emphasizes control as a risk mitigation strategy The chapter recommends a risk-based
More informationISO Part 1 and Part 2 Compliance Requirements. Cathriona O Neill
ISO 11607 Part 1 and Part 2 Compliance Requirements Cathriona O Neill I.S. EN 11607 Introduction ISO 11607 is the principal guidance document. Packaging for terminally sterilised medical devices - Part
More informationREUSABLE MEDICAL DEVICE VALIDATION
All sterilization processes require validation of the efficacy and reproducibility of the process. Depending on the type of sterilization, this may be accomplished by partial, sub-lethal, or repetitive
More informationSystems-Based Inspections for Cleaning Validation
Systems-Based Inspections for Cleaning Validation FDA DG 230 July 27, 2015 Rockville, MD Destin A. LeBlanc Cleaning Validation Technologies www.cleaningvalidation.com 1 Objectives Describe and/or identify:
More informationLUNCH AND LEARN. September 11, CE Activity Information & Accreditation
LUNCH AND LEARN Environmental Monitoring and Contamination Control September 11, 2015 Featured Speaker: Scott Sutton, Ph.D. The Microbiology Network N. Chili, New York 1 CE Activity Information & Accreditation
More informationCompounding Pharmacies and Water
Compounding Pharmacies and Water Scott Sutton, PhD scott.sutton@microbiol.org August 21, 2014 46 Disclaimer I am an independent consultant. I have been involved with USP for many years. I do not represent
More informationOn-Site GMP Training GMP COMPLIANCE TECHNICAL
PharmaNet On-Site GMP Training GMP COMPLIANCE TECHNICAL 284 E Lake Mead Pkwy Suite C-278 Henderson, NV 89015 Phone: 702-558-0094 Fax: 702-558-0079 www.gmpseminars.com Key to Level of Program Level A: Program
More informationValidation Needs for Sterilization by Aseptic Filtration
Validation Needs for Sterilization by Aseptic Filtration DCVMN Workshop, Hyderabad, 4-8 April 2016 Ramesh Raju Associate Director - Provantage Validation Services Overview Key Regulatory and Industry guidelines
More informationHow to Handle Excursions in Environmental Monitoring (EM) and Personnel Monitoring (PM) in an Aseptic Processing Plant
How to Handle Excursions in Environmental Monitoring (EM) and Personnel Monitoring (PM) in an Aseptic Processing Plant Randy Hutt, Ph.D. Associate Director Sterility Assurance and Microbiology Luitpold
More informationInnovative. to the pharmaceutical, biotechnology and advanced technology. and equipment. Our learning management
Innovative S o l u t i o n s Pharma-Tech Process and Facilities Services is an industry leader in providing innovative technical consulting and staff-augmentation services to the pharmaceutical, biotechnology
More informationValidation Study on How to Avoid Microbial Contamination during Pharmaceutical Production
Biocontrol Science, 2015, Vol. 20, No.1, 1 10 Review Validation Study on How to Avoid Microbial Contamination during Pharmaceutical Production HIDEHARU SHINTANI 1-13-27, Kasuga, Bunkyo, Tokyo 112-0003,
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
1 2 3 23 June 2016 EMA/CHMP/BWP/534898/2008 rev. 1 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on the requirements for quality documentation concerning biological investigational
More informationANNEX 1: COMMENT SUBMISSION DOCUMENT
Submission Comments on: GMP Annex 1: Proposal for amendments to the environmental classification table for particles and associated text, amendment to section 42 concerning acceptance criteria for media
More informationSwab and Samplers Test Kits Quality control as easy as 1, 2, 3
Swab and Samplers Test Kits Quality control as easy as 1, 2, 3 Merck Millipore is a division of Environmental monitoring Sample, incubate, count Merck Millipore s Samplers and Swab Test Kits simplify routine
More informationCompounding Pharmacies and the USP <71> Sterility Tests
Compounding Pharmacies and the USP Sterility Tests Scott Sutton, Ph.D. scott.sutton@microbiol.org 49 41 Disclaimer I am making this presentation as an independent agent I am not making this presentation
More informationLABORATORY COMPLIANCE
1 LABORATORY COMPLIANCE Jeanne Moldenhauer Vectech Pharmaceutical Consultants, Inc. Farmington Hills, MI INTRODUCTION Implementation of the Systems-Based Inspection Guideline for drug manufacturers in
More informationHISTORY AND MILESTONES
HISTORY AND MILESTONES HISTORY AND MILESTONES DOC S.r.l., Documentation Organization & Consultancy, was established in 1997 by MASCO group C.E.O. Eng. Alberto Borella and Eng. Paolo Curtò who became Managing
More informationEFFECTIVE MANAGEMENT OF THE PROCESS VALIDATION LIFECYCLE VALIDATION MASTER PLAN DEVELOPMENT
EFFECTIVE MANAGEMENT OF THE PROCESS VALIDATION LIFECYCLE VALIDATION MASTER PLAN DEVELOPMENT Paul L. Pluta, PhD Journal of Validation Technology Journal of GXP Compliance University of Illinois at Chicago
More informationOverview of Generic PET Applications. Sema Basaran, Ph.D. The 34 th Annual High Country Nuclear Medicine Conference.
Overview of Generic PET Applications Sema Basaran, Ph.D. The 34 th Annual High Country Nuclear Medicine Conference. March 1-6, 2013 Disclaimer This presentation reflects the views of the presenter and
More informationT H E P R O P O S A L F O R T H E Y E A R
Training T H E P R O P O S A L F O R T H E Y E A R 2 0 1 9 Our GMP courses combine a convenient format with an effective, interactive learning experience. To maximize and customize your professional development.
More informationSTERILE PRODUCT COMPLIANCE RISK ASSESSMENT FOR ASEPTIC PROCESSING MANUFACTURING
STERILE PRODUCT COMPLIANCE RISK ASSESSMENT FOR ASEPTIC PROCESSING MANUFACTURING Expertise and Training YOUR RISK Aseptic manufacturing processes of sterile products are highly vulnerable against microbial/
More informationVALIDATION OF ASEPTIC PROCESSES
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 007-5 1 July 2009 RECOMMENDATION ON THE VALIDATION OF ASEPTIC PROCESSES PIC/S July 2009 Reproduction prohibited for
More informationMoist Heat Terminal Sterilization for Controlled Release Materials
Moist Heat Terminal Sterilization for Controlled Release Materials James Agalloco Agalloco & Associates Presentation Overview Terminal Sterilization Fundamentals Steam Radiation Current Best Practices
More informationApplication of Quality Risk Management Tools for Cell Therapy Manufacturing
Application of Quality Risk Management Tools for Cell Therapy Manufacturing 17 th ISCT Annual Meeting May 20, 2011 Jean Stanton Associate Director, Product Quality Management Janssen Supply Chain Conflict/Disclaimer
More informationSESSION 14. Documentation Requirements and Management for Validation. 30 March Frits Vogt
Validation Services SESSION 14 Documentation Requirements and Management for Validation 30 March 2017 Frits Vogt fritsvogt@valserv.nl Content Documentation Requirements and Management for Validation I.
More informationSubpart B Organization and Personnel, 21 CFR Responsibilities of the quality control unit.
FDA inspections continue to focus on CGMP violations related to basic GMP controls. A survey of Warning Letters issued in 2013 on CMC (Chemistry / Manufacturing / Controls) violations reveals an emphasis
More informationGMP Inspection Process. Types of GMP Inspection. Module 18 Slide 1 of 14 WHO - EDM
GMP Inspection Process Types of GMP Inspection Module 18 Slide 1 of 14 WHO - EDM Objectives 1. To review the different types of inspection 2. To examine when each is appropriate 3. To discuss inspections
More informationJournal of Atoms and Molecules
Review article Journal of Atoms and Molecules An International Online Journal ISSN 2277 1247 CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRIES Abhishek Raj Senior R&D Officer, Quest Pharmaceuticals Pvt.
More informationSterisart BD Media and Fluids One-Stop Shopping for Sterility Testing
Sterisart BD Media and Fluids One-Stop Shopping for Sterility Testing Sterisart Increasing Safety and Reliability Pharmaceuticals, biologicals, medical devices and any material claiming to be sterile must
More informationImplement Effective Computer System Validation. Noelia Ortiz, MME, CSSGB, CQA
Implement Effective Computer System Validation Noelia Ortiz, MME, CSSGB, CQA Session Outline 1 2 3 4 5 Understanding Regulations and Guidelines Pertaining to Computer Systems Integrate SDLC and GAMP 5
More informationQUALIFICATION and VALIDATION Open Discussion Workshop QP Forum 21 st April 2016
QUALIFICATION and VALIDATION Open Discussion Workshop QP Forum 21 st April 2016 Representatives from cross section of companies were at this workshop namely: Abbott, Stiefel, Abbvie, Pfizer, Helsinn, BMS,
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
14 September 2017 EMA/CHMP/BWP/534898/2008 rev. 1 Committee for Medicinal Products for Human Use (CHMP) Guideline on the requirements for quality documentation concerning biological investigational medicinal
More informationA Life Cycle Approach to Raw Material Qualification for Cell and Gene Therapy Products
A Life Cycle Approach to Raw Material Qualification for Cell and Gene Therapy Products Angela Whatley, Ph.D. Office of Tissues and Advanced Therapies CBER/FDA CMC Strategy Forum on Cell & Gene Therapies
More informationPharmaceutical Facilities
500 Pharmaceutical Facilities Design, Layouts and Validation Prof. Manohar A. Potdar Department of Quality Assurance Poona College of Pharmacy Bharati Vidyapeeth University Pune-411038 India PharmaMed
More informationGMP - Annex 1 beabsichtige Änderungen
GMP - Annex 1 beabsichtige Änderungen Dr. A. Terhechte, BR-Münster Status Quo http://www.emea.eu.int/inspections/whatsnew.html Status Quo 21. September 2005 berichtigter Entwurf 30. April 2006 - Möglichkeit
More informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 14161 Second edition 2009-09-15 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results Stérilisation des produits
More informationUSP Chapter 823 USP 32 (old) vs. USP 35 (new)
USP Chapter 823 USP 32 (old) vs. USP 35 (new) Sally W. Schwarz, MS, BCNP Research Associate Professor of Radiology Washington University School of Medicine St. Louis, MO Why USP Chapter ? FDA has
More informationواكسنهاي. PROCESS VALIDATION Of MULTIVALENT BACTERIAL VACCINES
معتبرسازي فرايند واكسنهاي توليد باكتريايي چند گانه PROCESS VALIDATION Of MULTIVALENT BACTERIAL VACCINES ١ Program Overview Terms & Definitions Implementing a Validation Program Essential Requirements Matrix
More informationPage 1 of 6 U.S. Food & Drug Administration Drugs Home Drugs Guidance, Compliance & Regulatory Information Guidances (Drugs) Questions and Answers on Current Good Manufacturing Practices, Good Guidance
More informationQuality by Design in Critical Filtration Operations
Quality by Design in Critical Filtration Operations Michael Payne Senior Biosafety Technical Consultant Yanglin Mok Technical Manager Objectives Define quality by design (QbD) and Quality Risk Management
More informationIN THIS SECTION MICROBIOLOGY TESTING EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT. Bacterial Endotoxin (LAL) Testing
EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT IN THIS SECTION MICROBIOLOGY TESTING Microbial assays involve a variety of tests, from the determination of the numbers and types of organisms naturally present
More informationSupersedes Division Name Revision No. 0 Export Division Page No. 1 of 9
Page No. 1 of 9 Control Status 1.0 Purpose To lay down a procedure for conducting GMP inspection and report writing for issue of Written Confirmation for for medicinal products for human. 2.0 Scope This
More informationGMP On Site Series. GMP Essentials
GMP On Site Series GMP Essentials GMP Basics Objectives 1. State the critical definitions of the pharmaceutical industry. 2. Describe the law as it applies to various critical functions. 3. State the history
More informationValidation of Sterilizing Grade Filters
Validation of Sterilizing Grade Filters Presented by Laura Okhio-Seaman Sartorius Corporation 1 Sterilizing Grade Filters The definition of a sterilizing grade filter is one that will produce a sterile
More informationINSPECTOR S OBSERVATIONS AND WARNING LETTER
Microrite, Inc. San Jose, CA, USA, http://www.microrite.com AIR VELOCITY MEASUREMENTS AND CORRELATION TO SMOKE STUDIES FOR ASEPTIC OPERATIONS KEYWORDS Air Velocity, Air Flows, Smoke Study, Air Pattern
More information