sterility assurance Prove the power and your processes
|
|
- Ezra Logan
- 6 years ago
- Views:
Transcription
1 sterility assurance Prove the power and efficacy of your processes
2 sterility assurance programs: an introduction YOUR CHALLENGES Contamination events cost a lot of time and money. Sterility problems can lead to product recalls. Inadequate process validations are being cited by FDA. Validation guidelines are vague. Inferior processes can cause back orders. OUR SOLUTION Comprehensive services are tailored to suit your needs and linked to provide a complete picture for regulatory agencies. Expertly designed validation programs. Support for ongoing environmental monitoring. Total testing program management. Dedication to superior execution. assurance Why work with WuXi AppTec? Regulatory expectations for medical products have changed, requiring more testing and more data. WuXi AppTec has the expertise that can help the process be easier, faster, and more successful. EXPERIENCED WuXi AppTec s scientists have over 20 years experience with hundreds of validations and diverse devices. ENGAGED Our industry-recognized experts serve on the standards committees that write reusable device guidances. RECOGNIZED As an industry leader, we have partnered with most of the major medical device companies. INTEGRATED We offer seamless services in all of the disciplines required to complete reusable device studies. 2
3 our program components WuXi AppTec offers total program components for sterility assurance, including: Clean Room Design Requirements Develop the specifications to meet your environmental needs. Clean Room and Utility Systems Validation and Monitoring Prove the cleanliness of your environment and the quality of your utility systems. Cleaning Validations Prove the efficacy of your cleaning process. Reprocessing Validations Prove the efficacy of your cleaning, disinfecting & sterilization methods. Sterilization Validations Prove the strength of your sterilization methods. Dose Audits / Lot Release Prove the stability of your process over time. Packaging Validation Prove the integrity of your packaging. our proven process CONSULT TO DETERMINE NEEDS DESIGN PRODUCT-SPECIFIC PROGRAM EXECUTE CUSTOMIZED TESTING PLAN DELIVER RESULTS Clarify program goals Understand product specifications Consider current regulatory expectations Link study designs Coordinate product transfers Perform sampling plans Provide submissionready testing manual Supply long-term control plan Run customized assays
4 considerations for clean room design Designing clean rooms and utility systems is about more than blueprints and build specifications. You need to use a systematic approach for developing and managing the architecture to optimize the efficiency of your manufacturing processes, ensure the safety of your product, and make it easy to maintain monitoring programs over the long run. Our experts can help you consider all of these important design requirements, based on your product specifications. KEY FACTORS Process flow Materials flow Key microbial control points Water system and process gas control clean room validations using our established process CONSULT ESTABLISH CONTROL STRATEGY EXECUTE STRATEGY & PERFORM VALIDATIONS MAINTAIN CONTROL On-site visit Determine project needs Assess manufacturing/ controlled environments Identify other key areas to monitor Design validation plan Develop: Continuous monitoring program Sampling schedules Sampling procedures Conduct sampling on-site Perform testing Train internal staff Evaluate validation data Recommend limits Suggest monitoring frequency
5 testing services for controlled environments WuXi AppTec provides manufacturers with testing services designed to help validate, monitor, and ensure the integrity of GMP/controlled environments from laboratory counters to cleanrooms to entire manufacturing facilities. With our many years of microbiological testing for medical product industries, plus our experience in operating our own in-house manufacturing facilities, we have the expertise to advise you in designing a custom testing program to fit your particular needs. Environmental Monitoring An environmental monitoring program can be used to assess the microbial levels of critical areas and evaluate the effectiveness of various manufacturing controls, including cleaning procedures, HEPA filtration, disinfection, gowning, and aseptic handling procedures. Monitoring of products used during manufacturing, such as water, cleaning solutions and gases, can also be helpful in demonstrating and maintaining environmental control. WuXi AppTec s experts can help you design and implement such a program. A variety of service options are offered: Testing Services You follow your own protocol/test plan for selection of sites and collection of the samples, which are shipped to us for incubation, enumeration, and characterization/identification. We provide you with test results for your analysis. Comprehensive Services We consult with you to develop an appropriate protocol and sampling plan. You follow the established sampling plan, then ship the samples to us for incubation, enumeration, and characterization/identification. We analyze the data and provide a formalized final report that includes the test results and recommendations for establishing Alert and Action levels. Supplemental Services On-site assessment & monitoring ID of environmental isolates Tracking of isolates Trending of results Training of your personnel for sample collection Rental of air sampler Culture media for sampling purposes Disinfection Process Efficacy This type of study is used to evaluate the log reduction of a disinfection process used on products or materials. It evaluates specific disinfection agents, alone or in combination, and is usually conducted with a variety of microorganisms and viruses a panel of organisms typically used for efficacy testing; those of the most concern to product integrity or application; or environmental/product isolates. Efficacy of Sanitizers / Surface Cleaning Validation This type of study is used to determine the efficacy of sanitizing agents on various inanimate surfaces (such as counters, floors, and other areas/materials that are routinely cleaned). It is typically conducted with a variety of microorganisms and viruses most often those that are of concern in the environment or product application. NOTE: Standard methods (ASTM, AOAC, USP, ISO, etc.) can be modified, expanded or otherwise customized for specialized challenges or to fulfill particular requirements. ADDITIONAL SERVICES Microbial Identification Viral Clearance / Inactivation Studies Water Testing / TOC Chemical / Analytical Testing Custom Protocols Consultation Services
6 cleaning validations Planning a comprehensive strategy for the lifecycle of your sterile product, including cleaning validations, is crucial to avoiding regulatory issues. Because cleaning and sanitization processes may have direct impact on product purity, stability, potency, safety and efficacy, global regulatory agencies are requiring a thorough risk assessment and validation of all of your cleaning processes for everything from clean rooms to production equipment to cleaning agents. KEY CONSIDERATIONS Cleaning agents Techniques Time points Surface materials Potential microbial/viral contaminants guidance REGULATIONS The FDA has provided positions on sterilization programs in various guidance documents and warning letters. 21 CFR , Equipment Cleaning and Maintenance, states equipment and utensils shall be cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. The following FDA Guidance Documents are suggested resources for additional information: Guidance for Reprocessing (Draft) Amendments to Sterility Test Requirements for Biological Products WUXI APPTEC EXPERIENCE WuXi AppTec is the clear leader in this field with more than 20 years experience and has developed standard cleaning procedures for bacterial and viral contamination. Our experienced PhD-level virologists and microbiologists have the investigational expertise to identify novel contaminants and develop customized assays for you. For example, simulating the exact spraying and cleaning processes at small scale is critical to ensure that larger-scale cleaning procedures will provide the same results as the validation program.
7 reprocessing validations Programs designed specifically for your reusable products will result in compelling data answering regulatory demands while supporting patient safety. PEACE OF MIND Be confident that your reprocessing protocols are effective and your reusable devices will be safe for patients. APPROVAL Increase your odds of regulatory approval with strong reprocessing data for your device. DIFFERENTIATION Stand out from your competition with validated procedures for cleaning, disinfecting, and sterilizing your product. IDENTIFY CRITERIA SOIL & INOCULATE CONDUCT TESTING PROVIDE RESULTS Identify the targeted acceptance criteria and develop the best testing protocol to prove the efficacy of your process. Simulate clinical use by soiling/inoculating device before submission to cleaning, disinfection and sterilization processes. Perform manual and/or automated process(es) and test for quantitative endpoints such as TOC, protein and hemoglobin. Provide a final report, including summary of data and a clear interpretation of proof of process efficacy. WuXi AppTec is able to perform completely in-house the full spectrum of cleaning/disinfecting/sterilizing processes whether manual, ultrasonic or automated allowing faster turnaround times and better sample control. Included in our on-site equipment is a STERIS Used with permission of STERIS Reliance Genfore Washer/Disinfector that offers a wide variety of options to meet specific needs.
8 microbiology services Microbial assays involve a variety of tests from determination of the numbers and types of organisms naturally present in a product to the assessment of controlled environments. With our comprehensive menu of microbiology services, WuXi AppTec provides testing across the product development life cycle and beyond: R&D and screening, in-process release and validations, and finished product delivery. Endotoxin Testing Kinetic chromogenic Kinetic turbidimetric Gel clot Determining the reduction of endotoxin contamination is key to proving your production processes are under control and your products are suitable for lot release. Bioburden Testing Aerobic counts Anaerobic counts Fungi/mold counts Spore counts Recovery efficiency validation Selective tests to isolate organisms of interest The type of bioburden testing that should be performed depends on the information that is needed. Controlled Environment Testing Growth and enumeration of air, surface and water samples Growth and enumeration of water coliforms Sampling materials and equipment for testing your critical environments Our scientists can help you manage your entire microbial environmental sampling program. Growth Promotion USP <61> method USP <71> method Additional organisms available to fit your needs. Prepared media must be tested for its ability to support microbial growth prior to use for testing. Microbial Identification ABI 3130 Genetic Analyzer BioMerieux VITEK 2 system DuPont RiboPrinter system WuXi AppTec performs microbial identification and characterization in-house using a number of techniques. Sterility Testing Biological indicators Suitability testing (B/F) Total immersion Membrane filtration Rinse method Product sterility testing is typically performed either as a routine lot release test to monitor product after sterilization or as part of validation programs. Our sterility menu includes methods that comply with ANSI/AAMI/ISO, and USP for solid materials, tissues, fluid path devices, and liquids.
9 package system testing WuXi AppTec s ISTA-certified laboratory provides manufacturers with an array of services for their packaging systems. Testing services, which can be used to demonstrate compliance with regulatory requirements, include Sterile Barrier System (SBS) and packaging system design qualification testing. Sterile Barrier System (SBS) Testing WuXi AppTec offers a program of SBS services that features integrity evaluations, seal and whole package strength evaluations, and stability testing with accelerated and real-time aging studies. Available tests include: SBS Seal and Whole Package Strength Testing ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications SBS Integrity Testing ASTM F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection ASTM F F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ASTM F 2096 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test) SBS Stability Testing ASTM F1980 Standard Guide for Accelerated Aging of Sterile Medical Device Packages Real-Time Aging Sample Storage and follow up Packaging System Design Qualification Testing Available tests include: ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems ASTM D7386 Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems ASTM D4332 Environmental Conditioning ISTA 1 and 2 Series ISTA 3A ISTA 4AB ISTA 7D and 7E ISTA Environmental Conditioning
10 supporting services: chemistry testing From incoming material screening to lot release testing, WuXi AppTec offers a wide range of chemical assays for assessing the safety of medical device materials and manufacturing processing aids. Wet Chemistry Analytical Chemistry Physical Properties Gluteraldehyde Residues Conductivity Karl Fischer Moisture Osmolality USP 381 Physicochemical Protein Assay TOC Hemoglobin Carbohydrate USP Assays USP Identification Tests USP Heavy Metals EO Residual Panels EO Exhaustive Analysis EO Residuals ECH, EG Residuals Vendor Comparisons Viscosity Specific Gravity Melting Point Boiling Point Flash Point Residue on Ignition Moisture FT-IR Scans Refractive Index UV-VIS Spectrophotometry Turbidity State-of-the-art equipment Highly experienced staff Fully customizable PROGRAM FEATURES testing programs Data integration into risk assessments Qualified methods available R&D, GLP and GMP services Easy access to staff toxicologists Regulatory and consulting services
11 consulting services Recently, FDA auditors have shown heightened awareness and increased expectations of sterility assurance programs, focusing especially on: Use of ISO Physical Testing of Packaging Sanitizer Efficacy Validations Environmental Monitoring Reprocessing Validations expertise WuXi AppTec scientists and regulatory experts are available to help you address your challenges from materials selection to cleaning instructions by identifying the current guidance applicable for your product and assisting in the development and implementation of a strategic approach. We also specialize in finding the root cause if you ve had a failure, and determining the most effective steps you can take to eliminate the issue. Our experts partner with your team to identify the best paths to avoid costly regulatory failures and move forward for success.
12 sterility assurance PROGRAM FEATURES Full range of services, with testing to meet regulations worldwide. Expert guidance in designing product-specific testing plans for successful submissions. Specialized studies in sterilization and reprocessing validations. Total validation program management option. PROVEN EXPERTISE Over 20 years of experience. Expert members on international guidance committees. Leaders/participants on industry committees. Registrations/Certifications: ISO FDA ISTA Products: Biologics Devices Tissues Combination Products Pharmaceuticals Submission-ready validation report manuals. ST. PAUL 2540 Executive Drive St. Paul, MN ATLANTA 1265 Kennestone Circle Marietta, GA PHILADELPHIA 4751 League Island Blvd. Philadelphia, PA PS
STERILIZATION VALIDATION IN THIS SECTION REPROCESSING VALIDATIONS FOR REUSABLE MEDICAL DEVICES. Radiation Sterilization Validation
STERILIZATION 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,
More informationServices for Medical Devices. Expert solutions for product development from concept to commercialization
Services for Medical Devices Expert solutions for product development from concept to commercialization Services for Medical Devices WuXi AppTec s comprehensive testing programs and expert guidance help
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 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 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 informationCERTIFICATE OF ACCREDITATION
CERTIFICATE OF ACCREDITATION ANSI-ASQ National Accreditation Board 500 Montgomery Street, Suite 625, Alexandria, VA 22314, 877-344-3044 This is to certify that Dynatec Scientific Laboratories, Inc. 11940
More informationCERTIFICATE OF ACCREDITATION
CERTIFICATE OF ACCREDITATION ANSI National Accreditation Board 11617 Coldwater Road, Fort Wayne, IN 46845 USA This is to certify that Dynatec Scientific Laboratories, Inc. 11940 Golden Gate Road El Paso,
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 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 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 informationHow is Sterilization Validation Performed by the Medical Device Manufacturer?
How is Sterilization Validation Performed by the Medical Device Manufacturer? Rod Parker, Ph.D. Sr. Principal Scientist Stryker Instruments Division May 9, 2016 DISCLOSURE I am an employee of Stryker Corporation.
More informationADVANCED TESTING LABORATORY
RESOLVING ISSUES. REDUCING RISK. ADVANCED TESTING LABORATORY PROVIDING PEACE-OF-MIND. ADVANCED TESTING LABORATORY 6954 Cornell Road Cincinnati, OH 45242 513.489.8447 513.489.9291 fax ClientRelations@advancedtesting.net
More informationAt Your ServIce. Microbiology Services. The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.
At Your ServIce Microbiology Services The life science business of Merck operates as MilliporeSigma in the U.S. and Canada. Microbiology Services Optimize your QC lab workflow and ensure regulatory compliance
More informationWhy Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services
Why Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services Disclosures I, Ross Caputo, declare no conflicts of interest, real or apparent, and
More informationHot 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 informationPrecision. Proficiency. Proximity.
Precision. Proficiency. Proximity. Precision Accuracy in testing is paramount to ensuring product safety and efficacy. And fast turnaround times are critical to keeping your project on schedule. With
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 informationQuality is Our Promise.
Quality is Our Promise. Our goal at KRS Global Biotechnology is to provide the highest quality pharmaceutical preparations. We accomplish this with an unrivaled quality assurance and quality control program
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 information2018 North America Lab Services Fee Schedule
Product Bioburden - ISO 11737-1 Bioburden sample pooling, sample item portion (SIP) and additional material fees may apply as required by the sample type. BIO110 Bioburden: Aerobic bacteria only per unit
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 informationPACKAGE TESTING & VALIDATION IN THIS SECTION EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT
EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT PACKAGE TESTING & VALIDATION A sterile medical device, which includes the packaging, must function as labeled for the shelf-life claimed for the device. The primary
More informationResponses to Questions for SYSTEM 1E Process Monitoring and Validation Webinar
Responses to Questions for SYSTEM 1E Process Monitoring and Validation Webinar MONITORING THE SYSTEM 1E PROCESSOR Q: I want to confirm that there is no need for a Biological Indicator (BI) and that use
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 informationPACKAGE TESTING AND VALIDATION SERVICES
PACKAGE TESTING AND VALIDATION SERVICES A sterile medical device, which includes the packaging, must function as labeled for the shelf-life claimed for the device. The primary package must maintain its
More informationMicrobiology Research Associates
2017 Microbiology Research Associates List of Services www.mra-bact.com 33 Nagog Park Acton, MA 01720 978.263.2624 Page 1 of 11 Microbiology Tests Pharma/Biotech/Medical Devices Time From Sample Receipt
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 informationMicrobiological Consideration for Non-Sterile Pharmaceutical
May 1-3, 2012 Javits Center New York, NY Microbiological Consideration for Non-Sterile Pharmaceutical Dr. Leonard W. Mestrandrea Principal Consultant MESTRANDREA CONSULTING LLC Title Date Microbial Control
More informationfor IND and RDRC Regulated PET Compounding
Overview of USP Chapter for IND and RDRC Regulated PET Compounding Distributed Manufacturing of PET Radiopharmaceuticals for Multi-Center Clinical Trials SNM, Annual Meeting Toronto, Ontario, Canada
More informationapplying a unique combination of disciplines consulting, preclinical, toxicology,
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA's MRO Approach
More informationPhase Appropriate GMPs for IMPs. Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017
Phase Appropriate GMPs for IMPs Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017 1 Lets start with References https://mhrainspectorate.blog.gov.uk/2016/0 5/20/manufacture-of-investigationalmedicinal-products-frequently-askedquestions/
More informationGuidance. Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs DRAFT GUIDANCE
Guidance Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and
More informationStudy Title Determination of the Antiviral Effectiveness of KHG FiteBac Technology Test Substance Delivered via Pipette Against MS2 Bacteriophage
Study Title Determination of the Antiviral Effectiveness of KHG FiteBac Technology Test Substance Delivered via Pipette Against MS2 Bacteriophage Test Method ASTM International Standard Test Method E1053
More informationFZ LABORATORY SERVICES
FZ LABORATORY SERVICES For those working in biological product manufacturing/aseptic process filling: you can greatly benefit from support by Franz Ziel GmbH (FZ) with many years experience in scientific
More informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 14161 First edition 2000-10-01 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results Stérilisation des produits
More informationThe Application of Pharmaceutical cgmp to Live Bacterial Products. James Harris Business Development Manager
The Application of Pharmaceutical cgmp to Live Bacterial Products James Harris Business Development Manager The Objective CMC expectations of a cgmp live bacterial biopharmaceutical project Overview Define
More informationPharmaceutical Reference Standards: Overview and Role in Global Harmonization
Matthew Borer, Ph.D., Advisor Pharmaceutical Reference Standards: Overview and Role in Global Harmonization 3rd DIA China Annual Meeting Beijing, China, 16-18 May, 2011 What is a Pharmaceutical Reference
More informationSupplementary Training Modules on Good Manufacturing Practice. Validation. WHO Technical Report Series, No. 937, Annex 4.
Supplementary Training Modules on Good Manufacturing Practice Validation WHO Technical Report Series, No. 937, 2006. Annex 4. Validation Slide 1 of 48 August 2006 Validation! Part 1. General overview on
More information10 Things You Should Do Before You Validate Your Next Package
sponsored by 10 Things You Should Do Before You Validate Your Next Package Before you set out to validate a medical device package design or process, you ve got to do your homework. You need to understand
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 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 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 informationEU and FDA GMP Regulations: Overview and Comparison
THE QUALITY ASSURANCE JOURNAL, VOL. 2, 55 60 (1997) EU and FDA GMP Regulations: Overview and Comparison The increasing emphasis on global supply of drug products, as well as starting materials and investigational
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 informationSeptember 2, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
September 2, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: FDA Draft Guidance: Current Good Manufacturing Practice Interim
More informationGood Manufacturing Practices Purpose and Principles of GMP. Tony Gould
Good Manufacturing Practices Purpose and Principles of GMP Tony Gould Why GMP? Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality Medicines
More informationBest Practices For Cleaning Validation in the Aseptic Environment SUMMARY OF OUTLINE
Best Practices For Cleaning Validation in the Aseptic Environment Vivienne Yankah, PhD, CQE sanofi pasteur Ltd. Toronto, Canada SUMMARY OF OUTLINE Review Regulatory Standards for CV Designing and Developing
More informationWebinar Expert Module 3: GMP Inspections Dupont
Webinar Expert Module 3: GMP Inspections Dupont 26 January & 9 February 2018 GOP-Innovations your Partner for Practical Training and e-learning Milenko Pavičić Pharmaceutical microbiologist, trainer, coach
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 informationProduct Testing & Release. PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 10 th /11 th, 2007
Product Testing & Release PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 10 th /11 th, 2007 Product Testing Used to determine Safety, Purity, Identity, Potency, Quality Suitability
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 informationUSP <797> Compliance Common Challenges and Potential Solutions
USP Compliance Common Challenges and Potential Solutions Angela Yaniv, Pharm.D Assistant Director - Sterile Products May 2, 2017 - OSHP Annual Meeting Angela Yaniv has no actual or potential conflict
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 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 informationDisinfection Qualification Testing
Disinfection Qualification Testing Considerations for Aseptic & Cleanroom Manufacturing Environments White Paper Considerations for Aseptic and Cleanroom Manufacturing Environments Obtaining the highest
More informationBIOTECH-GERMANDE ENDOSCOPE REPROCESSING WITH BRUSHLESS CLEANING PROCESS CONDITIONS. Lionel PINEAU PhD
ENDOSCOPE REPROCESSING WITH BRUSHLESS CLEANING PROCESS CONDITIONS Lionel PINEAU PhD CONTENT General considerations Endoscope reprocessing, channel brushing, cleaning claims Description of the 2013 study
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 informationStudy Title Antibacterial Efficacy of Bio-Care Technology's Non-Porous Test Substance
Study Title Antibacterial Efficacy of Bio-Care Technology's Non-Porous Test Substance Test Method Japanese Industrial Standard Z 2801 Antibacterial Products Test for Antibacterial Activity and Efficacy
More informationManaging Your Environmental Isolates
Managing Your Environmental Isolates The Controversy Good practice includes the periodic challenge of prepared media with low levels of organisms. This includes USP indicator organisms as well as normal
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 informationHow to Select a Microbiology Contract Testing Laboratory? Tony Cundell, Ph. D. Microbiological Consulting, LLC Scarsdale, New York
How to Select a Microbiology Contract Testing Laboratory? Tony Cundell, Ph. D. Microbiological Consulting, LLC Scarsdale, New York June 13, 2017 IVT Microbiology Week 1 Presentation Overview Rationale
More informationProduct and Package Stability Studies The Application of FDA Guidance
Product and Package Stability Studies The Application of FDA Guidance Introduction In February 2008, the FDA issued Guidance to Industry dealing with physical tests for packaging for sterile medical devices
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 informationAccredited Laboratory A2LA has accredited WUXI APPTEC, INC. Marietta, GA for technical competence in the field of
Accredited Laboratory A2LA has accredited Marietta, GA for technical competence in the field of Biological Testing This laboratory is accredited in accordance with the recognized International Standard
More informationDesigning an effective cleaning procedure for medical devices through laboratory studies
Designing an effective cleaning procedure for medical devices through laboratory studies Elizabeth Rivera Technical Service Specialist STERIS Corporation elizabeth_rivera@steris.com October 2012 Agenda
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Seite 1 von 10 Inspections, Compliance, Enforcement, and Criminal Investigations Laboratoire Atlas Inc. 6/25/09 hhsbluebird Department of Health and Human Services Public Health Service Food and Drug Administration
More informationASTM D10-F02 Workshop FDA Regulatory Perspective. Patrick Weixel FDA Center for Devices and Radiological Health
ASTM D10-F02 Workshop FDA Regulatory Perspective Patrick Weixel FDA Center for Devices and Radiological Health 1 FDA Regulatory Perspective Focus of talk: Use of Standards Auditing Packaging Process Deficiencies
More informationGLP TESTING OF ZEROMOLD PLUS FOR ACINETOBACTER BAUMANNII
Southwest Research Institute Page 1 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 FINAL REPORT STUDY
More informationMetrics in Microbiology Monitoring Practices
Metrics in Microbiology Monitoring Practices Crystal Booth, M.M. Masters of Microbiology from North Carolina State University Former Associate Director of Microbiology at Novartis Metrics in Microbiology
More informationDISINFECTION QUALIFI CATION TESTING CONSIDERATIONS FOR THE ASEPTIC AND CLEANROOM MANUFACTURING ENVIRONMENT
DISINFECTION QUALIFI CATION TESTING CONSIDERATIONS FOR THE ASEPTIC AND CLEANROOM MANUFACTURING ENVIRONMENT by Dave Rottjakob, M.T. (ASCP) December, 2013 INTRODUCTION Obtaining the highest confidence that
More informationGlobal Sterile Liquid Capabilities
Global Sterile Liquid Capabilities The life science business of Merck operates as MilliporeSigma in the U.S. and Canada. WHY US? Our Global Sterile Liquid capabilities are designed to enhance and streamline
More informationCell Line Characterization and Product Testing for CHO-Derived Biopharmaceutical Products
Cell Line Characterization and Product Testing for CHO-Derived Biopharmaceutical Products Founded in 96, Eurofins Lancaster Laboratories is a global leader in comprehensive laboratory services enabling
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 informationCOMPLIANCE WITH EU ANNEX 15: VALIDATION AND QUALIFICATION
COMPLIANCE WITH EU ANNEX 15: VALIDATION AND QUALIFICATION Paul L. Pluta, PhD Journal of Validation Technology Journal of GXP Compliance University of Illinois at Chicago (UIC) College of Pharmacy, Chicago,
More informationProposed Revision of USP General Chapter Radiopharmaceuticals for Positron Emission Tomography Compounding <823>
Proposed Revision of USP General Chapter Radiopharmaceuticals for Positron Emission Tomography Compounding Ravi Ravichandran, Ph.D. Steve Zigler, Ph.D. February 21, 2011 Agenda Rationale for the
More informationYour Complete Outsourcing Partner EXPERTISE TO TURN YOUR IDEAS INTO REALITY
Your Complete Outsourcing Partner EXPERTISE TO TURN YOUR IDEAS INTO REALITY The difference between a vendor and a partner THERE ARE OEM SUPPLIERS. THEN THERE S B. BRAUN S OEM DIVISION. We set ourselves
More informationEnvironmental Monitoring of Aseptic Processing Areas - 1
Environmental Monitoring of Aseptic Processing Areas - 1 A war against an invisible enemy DCVMN - Víctor Maqueda - May 30, 31, June 1 2016 1 Training Course Agenda Overview of Environmental Monitoring
More informationQ Laboratories, Inc. Celebrating 50 Years of Scientific Excellence and Service. Methods Utilized
Technical Capabilities - LC-MS - ICP-MS - HPLC - GC - GC Headspace - FTIR - UV-VIS - Atomic Absorption - Microwave Digestion - Headspace Analysis - Total Organic Carbon (TOC) - Conductivity - Polarimetry
More informationGMP GUIDELINES. GMP Guides from Industry Organisations. FDA cgmp WHO GMP. cgmp Guide Drugs 21 CFR 210 GAMP. ISPE Technical Guides
FDA cgmp cgmp Guide Drugs 21 CFR 210 cgmp Guide Drugs 21 CFR 211 cgmp Guide Medical Device 21 CFR 808, 812, 820 cgmp Guide Biologics 21 CFR 600, 606, 610 Guideline List Human Drugs Guideline List Biologics
More informationVALIDATION AS A KEY TOOL IN SUCCESSFUL TRANSFER OR ESTABLISHMENT OF A MEDICAL DEVICE COMPANY IN A NEW FACILITY
VALIDATION AS A KEY TOOL IN SUCCESSFUL TRANSFER OR ESTABLISHMENT OF A MEDICAL DEVICE COMPANY IN A NEW FACILITY Oren Levin, Diane Gordon VisionCare Ophthalmic Technologies, POB 3879, Petah Tikva 49130,
More informationTests to Support Sterility Claim. Imtiaz Ahmed
Tests to Support Sterility Claim Imtiaz Ahmed Sterile Product As per TGO 77, a sterile product must comply with the requirements of the following tests: Sterility Test Bacterial Endotoxins Test Appendix
More information5.1.1 & Changes started in 2008 and were mainly driven under the Chairmanship of Prof Hans van Doorne 11/10/2017
5.1.1 & 5.1.2 V Iain Fenton-May Chairman Group 1 Methods of Preparation of Sterile Products Changes started in 2008 and were mainly driven under the Chairmanship of Prof Hans van Doorne 1 Methods of Preparation
More informationPACIFIC RIM CONSULTING COMMENTS ON FDA PROPOSAL TO REVISE GLPS
PACIFIC RIM CONSULTING COMMENTS ON FDA PROPOSAL TO REVISE GLPS 1. GLP Quality System While many of the requirements of the existing regulation are consistent with a GLP quality system, FDA believes that
More informationSynopsis: 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 informationWhere Quality Meets Flexibility
Where Quality Meets Flexibility is an industry leading 503B Outsourcing Facility providing sterile and non-sterile compounding services to hospitals, surgery centers, clinics, researchers & patients nationwide.
More informationBiocontamination control in pharmaceutical production
White Paper Data Sheet Biocontamination control in pharmaceutical production and compliance to ISO 14698 with validated active microbial air samplers Tim Sandle, Ph.D., Head of Microbiology at Bio Products
More informationISPE S GUIDES AND HOW THEY APPLY TO CLEANING AND CLEANING VALIDATION
ISPE S GUIDES AND HOW THEY APPLY TO CLEANING AND CLEANING VALIDATION Stephanie A. Wilkins, PE ISPE NORDIC CLEANING VALIDATION CONFERENCE 20 April 2016 Objectives > ISPE s Risk-MaPP Guide and its impact
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 informationIncremental GMPs. Presented by: Karen S. Ginsbury For: IFF October 31, Nov 02, PCI Pharmaceutical Consulting Israel Ltd.
Incremental GMPs Presented by: Karen S. Ginsbury For: IFF October 31, Nov 02, 2017 1/55 Sound Science Good Development Practice Traceability R&D Tox I II III IV What You Need Here Can t be generated here
More informationEUROPEAN INDUSTRIAL PHARMACISTS GROUP. Guidance on CPD for QUALIFIED PERSONS
EUROPEAN INDUSTRIAL PHARMACISTS GROUP Guidance on CPD for QUALIFIED PERSONS EIPG Guidance on CPD for QP Continuing Professional Development for Qualified Persons, Technical Directors and other Responsible
More informationProduct Testing & Release. PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 4 th /5 th, 2006
Product Testing & Release PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 4 th /5 th, 2006 Product Testing Used to determine Safety, Purity, Identity, Potency, etc. Suitability of
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 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 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 informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 14160 First edition 1998-03-15 Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid
More informationEU GMP ANNEX 1 CHANGES CLARIFICATION AND IMPACT
1 EU GMP ANNEX 1 CHANGES CLARIFICATION AND IMPACT UNDERSTAND THE PROGRESSION OF REGULATORY THINKING AND HOW TO SUCCESSFULLY IMPLEMENT THE PROPOSED CHANGES BALTIMORE, MD MAY 6TH AND 7TH, 2019 UNIVERSITY
More informationGxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 5 GLP Auditing 6 Pharmacovigilance Auditing 6 Vendor/Supplier Auditing 7
More informationto acquire Investor And Analyst Call Presentation January 4, 2008
to acquire Investor And Analyst Call Presentation January 4, 2008 Safe Harbor Statement The following information contains, or may be deemed to contain, forward looking statements (as defined in the U.S.
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 information