• 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
July 18, 2019 03:00 PM

Rapid Viable Monitoring and Regulations for Pharmaceutical Manufacturers

Written by PMS

Pharmacopoeias worldwide have promoted rapid or alternative microbiological methods for almost 20 years. All now have chapters in which the validation of alternative methods is described (e.g. United States Pharmacopeia (USP) <1223>, or European Pharmacopoeia (EP) 5.1.6), and these chapters continue to evolve with frequent updates.

Regulatory bodies have created specific pathways to facilitate the use of modern technologies in recent years. The FDA promotes the use of “Comparability Protocols” and building an Emerging Technologies Team (ETT) for the evaluation of change proposals. The European Medicines Agency (EMA) implemented the post-approval change management protocol and the possibility to request a “scientific advice meeting” with experts.

EU GMP released a new draft of Annex 1, Manufacture of Sterile Medicinal Products for public comment in December 2017. The updated document sets a milestone for adjustments needed within European agencies overseeing regulatory applications of drug products, and environmental monitoring in sterile manufacturing. Some of the top-level changes include:

  • After the patchwork of changes made to the 2008 version, the organization of the content has
    improved to be more accessible and consistent. For example, quality and manufacturing officers
    interested in environmental monitoring will readily find relevant content in Chapter 5 “Premises”
    and Chapter 9 “Viable and non-viable environmental and process monitoring”.
  • The total number of pages has increased from 16 to 50, the result of the inclusion of more
    detailed content.
  • Keyword searches demonstrate the increased usage of certain terms in comparison to the
    2008 version. For example, the word “risk” can be found 92 times compared to only 20 times before.
    Similarly, “microbial” is now present 68 times compared to 23 counts previously.

Download the full paper to learn more about implementation challenges of the industry, Annex 1 changes and more.

Filed Under: Particle Knowledge

Archives

  • January 2021 (3)
  • 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