• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+1-303-443-7100

 

  • Youtube
  • Twitter
  • Linkedin
  • English
    • 中文
    • 台灣
    • Singapore
    • Denmark
    • English / CH
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • Italiano
    • 日本語
    • 한국어
    • Português
    • Español
Newsletter

Search

  • Linkedin
  • Twitter
Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Particle Counters
    • Airborne Particle Counters
    • Liquid Particle Counters
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gas Particle Counters
    • Molecular Monitors
    • Environmental Monitoring Systems
  • Education
    • Knowledge Center
      • Papers
      • Webinars
      • Videos
      • Beginner Guide
    • Particle College
    • Training Services
    • Blog
  • Applications
    • Industries
      • Pharmaceutical
      • Semiconductor
      • Photonics & Optics
      • Aerospace
      • Cosmetics & Personal Care
      • Food & Beverage Safety
    • Annex 1
    • ISO 14644
    • 21CFR 11
    • ISO 21501-4
    • USP 788
    • USP 797
    • Continuous Viable Monitoring
    • Parts Cleanliness Testing
  • Services and Support
    • Product Calibration & Service
    • FMS/EMS Project Management
    • Contamination Control Advisors
    • Hardware & Software Support
    • Customer Service
  • About PMS
    • About Us
    • Contact Us
    • Why Choose PMS
    • Executive Team
    • Careers
    • Corporate Responsibility
    • COBE
    • Parent Company
    • Press Releases
    • ISO Registrations & Quality Policy
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance
News Blog
October 10, 2019 03:00 PM

Maintaining Quality in Stem Cell Products: ATMPs and Regulation (Series Part 2 of 4)

Written by PMS

What are ATMPs?

Stem cells are categorized as Advanced Therapy Medicinal Products (ATMPs) when undergoing substantial manipulation or when used for a different essential function. ATMPs are medicines for human use with gene, tissue or cell components. They can be classified into gene therapy medicines, somatic-cell therapy medicines, and tissue-engineered medicines, depending on how the medicine works in the body1.

In this blog series, we will be reviewing the European Commission’s 2017 Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products. The standard follows sterility assurance principles found in other guidelines for the manufacture of sterile products, such as Annex 1, Manufacture of Sterile Medicinal Products5. The scope covers all ATMPs granted marketing authorization, including those under hospital exemption.

Steps to Ensuring Quality

Every manufacturer should have a Pharmaceutical Quality System (PQS), which is the summation of all that is done to meet consistent, demonstrable quality standards. All activities must be effectively controlled for contamination-free finished products.

In order to build the PQS, a risk assessment is performed that encompasses the entire process. During the risk assessment, contamination is monitored to determine process needs, then broken down into individual elements and documented with the rationale for decisions made to mitigate risk. The risk assessment is reviewed regularly as part of quality management practices and product quality reviews. The risk-based approach (RBA) is applicable to all ATMPs and settings, whether they be hospital, academic or industrial, and the quality systems found in each are subject to the same standards.

Sterile ATMPs

The manufacture of sterile ATMPs has special requirements for minimizing risk of microbiological, particulate, and pyrogen contamination. Facilities and their equipment and processes must have optimal design that has been qualified and validated according to EU GMP Annex 11 and 15. All personnel must be trained with the skill and mission to ensure the product’s quality throughout manufacturing, packaging and distribution processes. The monitoring systems in place must be overseen by skilled personnel. A documented contamination control strategy should contain the detailed approach the company has taken to minimize contamination risk to the product.

To read more about the elements in sterile ATMP product quality, download the full paper here. In our next blog, we look at quality control guidelines for aseptic processing of ATMPs.

  1. Advanced therapy medicinal products: Overview. 2019.

 

Want to read more? Jump to other released posts in this series:

Part 1 of 4: Recent Developments in Regulation

Part 2 of 4: ATMP’s and Regulation

Part 3 of 4: Quality Control Considerations 

Part 4 of 4: Stem Cell Process Monitoring

Don’t miss an episode of this series. Register for updates on the right column of this page.

Click here to contact our experts for questions.

 

Filed Under: Particle Knowledge

Archives

  • January 2021 (2)
  • December 2020 (3)
  • November 2020 (7)
  • September 2020 (4)
  • August 2020 (1)
  • July 2020 (3)
  • June 2020 (3)
  • May 2020 (6)
  • April 2020 (13)
  • March 2020 (2)
  • February 2020 (5)
  • January 2020 (2)
  • December 2019 (2)
  • November 2019 (4)
  • October 2019 (6)
  • September 2019 (3)
  • August 2019 (3)
  • July 2019 (2)
  • June 2019 (1)
  • May 2019 (4)
  • April 2019 (1)
  • March 2019 (3)
  • February 2019 (2)
  • January 2019 (2)
  • September 2018 (1)
  • July 2018 (4)
  • June 2018 (1)
  • April 2018 (2)
  • March 2018 (2)
  • February 2018 (1)
  • January 2018 (2)
  • November 2017 (11)
  • October 2017 (9)
  • September 2017 (9)
  • August 2017 (1)
  • March 2017 (1)
  • January 2017 (1)
  • November 2016 (1)
  • August 2016 (1)
  • May 2016 (1)
  • March 2016 (2)
  • February 2016 (9)
  • January 2016 (1)
  • July 2015 (1)
  • June 2015 (3)
  • May 2015 (1)

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Knowledge Center

  • Particle Counting Education
  • Particle College – Electronics Industry Focused
  • Contamination Monitoring Videos
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP 788 Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

  • Website Disclaimer
  • Third Party Privacy Notice
  • Privacy Policy
  • Legal

© Copyright 2021 - Particle Measuring Systems is a Spectris company