• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    High Drug Loading Amorphous Solid Dispersions

    Parenteral Drug Delivery Trends

    Selecting the Right Outsourcing Model for Emerging Biotech

    Inhaled Drug Delivery Technology

    The Future of Biologics: Accelerating Production, Reducing Costs
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Altasciences Contributes to Vibegron Approval

    Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement

    Pfizer Selects Seven Bridges to Support RNA Sequencing Data

    ACG Launches ACG Laboratories

    Glatt and Aprecia Enter 3D-Printing Collaboration
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Why Increasing Solubility May Not Improve Bioavailability - In Vitro Predictions

    ACG Launches ACG Laboratories

    Glatt and Aprecia Enter 3D-Printing Collaboration

    Catalent Acquires Delphi Genetics

    Almac Group Completes $7M R&D Center
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing

    PwC Joins Medicines Manufacturing Innovation Centre

    AARDEX Group Partners with Pill Connect

    Phillips-Medsize and Subcuject Collaborate
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Altasciences Contributes to Vibegron Approval

    Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement

    Why Increasing Solubility May Not Improve Bioavailability - In Vitro Predictions

    Pfizer Selects Seven Bridges to Support RNA Sequencing Data

    ACG Launches ACG Laboratories
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Almac Group

    Alcami

    PCI Pharma Services

    Aphena Pharma Solutions

    test company saurabh
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Alcami

    PCI Pharma Services

    Syngene

    Baxter BioPharma Solutions

    Adare Pharma Solutions
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Columns

    Quality Metrics Feedback

    A look at FDA’s Quality Metrics Initiative, a complicated issue for all of pharma stakeholders

    Related CONTENT
    • Legacy Pharma Solutions
    • PCI Pharma Services
    • Catalent Pharma Solutions
    • Mogene
    • Regis Custom Pharma
    Gil Roth, President, Pharma & Biopharma Outsourcing Association09.16.19
    Shortly before Labor Day weekend, the FDA extended the deadline for its Quality Metrics Feedback Program by four months,1 giving license holders and manufacturers the opportunity to talk with the agency about their forays into measuring key quality attributes of products and facilities.

    According to the agency, the Quality Metrics (QM) Initiative is intended both to promote quality at drug manufacturing facilities—under the notion that measuring quality empowers companies to improve their quality systems—and to help the FDA refine its risk-based inspection program, as well as to help predict manufacturing-related shortages.

    PBOA has been involved in the industry response to the QM Initiative since a public meeting FDA held in 2015, which led to the establishment of our Quality Technical Group (QTG) and our involvement in a cross-industry consortium on QM. Our members have significant concerns about the QM Initiative, the massive new regulatory burden it may create, how it can be inadvertently biased against CDMOs, and the flaws in using it to rank facilities, rather than product-specific ratings, among many other issues.

    While it’s been invaluable for PBOA’s QTG to submit written comments to FDA’s QM docket (you can find our docket submissions at pharma-bio.org), there’s a lot of value in direct feedback and interaction with the agency, especially with a subject as complex as Quality Metrics.

    Last year, members of PBOA’s Quality Technical Group met with FDA’s QM team to talk about our concerns with the initial visions of the program, as well as some of the realities of how the CDMO sector works. I’ve written previously about the importance of the latter, but I can’t stress it enough: CDMOs are not the same as in-house pharma—be it innovator or generic—and often our regulators and legislators aren’t aware of how those differences mitigate against a one-size-fits-all model and the language of “drug manufacturers.” Our member companies aren’t averse to the idea of measuring quality across time, but we explained some of the differences between, for example, a pharma facility dedicated to a single product and a CDMO site with a dozen or more customers and dozens of SKUs: they can both be high quality sites that pass surveillance inspections with flying colors, but the in-house, single-product site is almost by definition going to be in greater control of its more limited set of product processes.

    The FDA team seemed legitimately surprised about aspects of how CDMOs work with their customers. Our members talked about the, shall we say, suboptimal tech transfers that sometimes occur with decades-old products, and how as CDMOs it’s their job to make the product effectively, but that any improvements to the process they develop could get rejected by the customer, who may not want to go through with filing a change to that product with the FDA (and with every other regulator in other regions where it may market that product).

    We also talked about the challenges around how CDMOs can generate a consistent set of metrics for FDA’s consumption when CDMO customers apply key terms inconsistently. When an FDA representative asked about metrics related to batch records, one of our members replied, “How do you define ‘batch’? Because I have five customers at one facility who have five different definitions of what a batch is, and that means they may each report batch-related metrics that don’t reconcile with other products at the same facility.” Rather than clutch their pearls and faint in horror, the FDA staff was interested in how common terms and definitions could get refined and implemented across the industry.

    That meeting was filled with candid but not confrontational conversation about the QM Initiative and how our members work with their customers, FDA and other regulatory bodies to ensure quality therapeutics reach patients. Our members took back input from FDA just as they heard our concerns. While our docket submissions can be comprehensive responses to guidance documents, sessions like this can provide room for conversation and learning.

    FDA’s Quality Metrics Initiative is a very complex and controversial issue for all of pharma and for CDMOs in particular. Hiding from the agency and hoping it will never get implemented is no way for a mature, responsible, quality-oriented sector like ours to behave. It’s my hope that CDMOs engage the FDA through the Feedback Program and help shape and inform the agency’s next steps. 

    References
    1. Federal Register: “Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program; Reopening of Submission Period” https://www.federalregister.gov/documents/2019/08/30/2019-18771/modernizing-pharmaceutical-quality-systems-studying-quality-metrics-and-quality-culture-quality


    Gil Roth
    President, Pharma & Biopharma Outsourcing Association

    Gil Roth is the President of the Pharma & Biopharma Outsourcing Association (www.pharma-bio.org). He can be reached at gil.roth@pharma-bio.org.
    Related Searches
    • Biopharma Outsourcing
    • Outsourcing
    • Manufacturing
    • it
    Suggested For You
    Legacy Pharma Solutions Legacy Pharma Solutions
    PCI Pharma Services PCI Pharma Services
    Catalent Pharma Solutions Catalent Pharma Solutions
    Mogene Mogene
    Regis Custom Pharma Regis Custom Pharma
    Adare Pharma Solutions Adare Pharma Solutions
    Handling & Assessing HPAPIs Handling & Assessing HPAPIs
    Changing the Face of CDMOs Changing the Face of CDMOs
    Drug Substances: Scale-Up Challenges Drug Substances: Scale-Up Challenges
    API to ADC: A Journey Through High Potency API to ADC: A Journey Through High Potency
    FDA Extends CRADA with CluePoints FDA Extends CRADA with CluePoints
    Preparing for Your CDMO Selection Process Preparing for Your CDMO Selection Process
    Roche Wins Two Approvals for Cancer Drug Rozlytrek Roche Wins Two Approvals for Cancer Drug Rozlytrek
    GenCure Reports Successful First Run of 80L Bioreactor GenCure Reports Successful First Run of 80L Bioreactor
    NIIMBL, FDA to Advance Innovation in Bio Manufacturing NIIMBL, FDA to Advance Innovation in Bio Manufacturing

    Related Columns

    • Biologics, Proteins, Vaccines
      Vaccines 2021

      Vaccines 2021

      Looking at the behavioral economics of vaccinations.
      Ben Locwin, Contributing Editor 01.27.21

    • A Potential “Marriage”

      A Potential “Marriage”

      Initiator companies and generics/CMOs working together.
      Emil W. Ciurczak, DoraMaxx Consulting 11.17.20

    • When Politics and Science Collide

      When Politics and Science Collide

      COVID-19 illustrates why science should always be a principal informer of politics to make better and smarter decisions.
      Ben Locwin, Contributing Editor 11.17.20


    • The Pandemic’s Become an Insurmountable Opportunity

      The Pandemic’s Become an Insurmountable Opportunity

      Every Cloud has a Silver Lining(?)
      Emil W. Ciurczak, Contributing Editor 10.14.20

    • Biologics, Proteins, Vaccines
      It Takes a Vaccine… To End The Pandemic [У нас есть хорошая вакцина]

      It Takes a Vaccine… To End The Pandemic [У нас есть хорошая вакцина]

      Race for the vaccines is heating up.
      Ben Locwin, Contributing Editor 09.09.20

    • cGMP Manufacture
      Keys to Biotech Success

      Keys to Biotech Success

      Four steps emerging biotech companies can take to achieve success
      Thierry Cournez, Head of End-to-End Solutions, MilliporeSigma 06.04.20


    • Analytical Services
      What Happens When the All-Clear Signal is Given?

      What Happens When the All-Clear Signal is Given?

      Maybe 3M had some good ideas?
      Emil W. Ciurczak, DoraMaxx Consulting 06.04.20

    • Almost Like the Olympics:

      Almost Like the Olympics:

      “Smaller, Faster, Smarter”
      Emil W. Ciurczak, DoraMaxx Consulting 05.05.20

    • Rapid Delivery of Medical Countermeasures Amid Pandemic

      Rapid Delivery of Medical Countermeasures Amid Pandemic

      Robert Erwin of iBio discusses the company’s COVID-19 vaccine development efforts and FastPharming manufacturing platform for the rapid delivery of vaccines
      Kristin Brooks, Managing Editor, Contract Pharma 05.05.20


    • The Supply Chain House of Cards

      The Supply Chain House of Cards

      The COVID-19 pandemic exposes pressures on extended global supply chains
      Emil W. Ciurczak, DoraMaxx Consulting 04.01.20

    • Analytical Services | Laboratory Testing
      The Supply Chain, as Developed by IKEA (some assembly required)

      The Supply Chain, as Developed by IKEA (some assembly required)

      Pick One from Column A, Two from Column B, etc.
      Emil W. Ciurczak, DoraMaxx Consulting 03.04.20

    • Coronavirus 2020

      Coronavirus 2020

      What’s The Impact To The World and Industry?
      Ben Locwin, Contributing Editor 03.04.20


    • Supply Chain
      What We Have is Failure to Communicate

      What We Have is Failure to Communicate

      When it comes to implementing track and trace technology, why is Pharma dragging its feet?
      Emil W. Ciurczak, DoraMaxx Consulting 01.28.20

    • Vision: 2020

      Vision: 2020

      You have exactly 366 days in 2020 to bring your clarity of vision to reality.
      Ben Locwin 01.28.20

    • Solid Dosage/Creams/Ointments
      The “Greening” of Solid Dosage Form Manufacturing

      The “Greening” of Solid Dosage Form Manufacturing

      Going “green” can mean saving big bucks for pharma manufacturers.
      Emil W. Ciurczak, DoraMaxx Consulting 11.20.19

    Trending
    • Century Therapeutics Significantly Expands Capabilities
    • Catalent Acquires Delphi Genetics
    • Sanofi And Translate Bio Expand Vaccine Collaboration
    • RotaChrom Technologies Partners With Cyclolab
    • Inside A Vaccine Trial
    Breaking News
    • Altasciences Contributes to Vibegron Approval
    • Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement
    • Pfizer Selects Seven Bridges to Support RNA Sequencing Data
    • ACG Launches ACG Laboratories
    • Glatt and Aprecia Enter 3D-Printing Collaboration
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • High Drug Loading Amorphous Solid Dispersions
    • Parenteral Drug Delivery Trends
    • Selecting the Right Outsourcing Model for Emerging Biotech
    • Inhaled Drug Delivery Technology
    • The Future of Biologics: Accelerating Production, Reducing Costs
    • Business Intelligence For (and From) the Lab
    • Communicating Your Contracting Priorities to Your Drug Company Customers
    • COVID-19 Impact Report
    • The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Clinical Trial Finds Metabolic Benefits for Polyphenols Formula
    JRF Technology Debuts Elderberry Oral Film Strip
    Danone Adds to Plant-Based Portfolio with Acquisition of Follow Your Heart Brand
    Coatings World

    Latest Breaking News From Coatings World

    Hempel Launches Sustainability Framework: Futureproof
    ChemQuest Hires Rich Gibson
    New Increase in Kynar Fluoropolymer Capacities at Arkema's Chinese Site
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences
    Abiomed Leader Michael Minogue Named AdvaMed Board Chairman
    TransEnterix Changes Name to Asensus Surgical
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Altasciences Contributes to Vibegron Approval
    Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement
    Pfizer Selects Seven Bridges to Support RNA Sequencing Data
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Madison Reed Raises $52 Million in Financing Round
    The Estée Lauder Companies Closes Becca Cosmetics
    Afro Sheen Launches New Brand Initiatives
    Happi

    Latest Breaking News From Happi

    PBA Opposes House Bill 2325 in West Virginia
    J.R. Watkins Tackles Pain with New Lines
    RB Launches Vanish Miracle
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Lowe-Martin Adds 2 KODAK NEXFINITY Digital Presses
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eaglewood Technologies debuts new anilox cleaning system
    INX International and VerifyMe sign supply agreement
    Soma partners with DTM Flexo Services
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    H&V Announces Price Increase
    Fiber Bond VE3 Technology Inactivates SARS-CoV-2 in HVAC Filtration Systems
    Citizens Provides $325 Million Senior Credit Facility to Nice-Pak
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    NuVasive Nabs Simplify Medical for $150M
    SeaSpine Begins Limited Launch of WaveForm TA (TLIF Articulating) 3D-Printed Interbody
    Nexus Spine Implants for Use in Spinal Surgeries Become Available
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    RFID Locks Market to Reach $9.93 Billion by 2027: Allied Market Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login