APR Sept/Oct 2023 - 73

« MANUFACTURING
2020. Yet, as the Regulatory framework invariably supersedes scientific
and technical regulations, full integration in the EU legislative system
is restricted at this point.
Post Brexit, the UK has not provided any specific advice on
implementation of Q12 guidance. Swissmedic applies the ICH Q12
guideline, with restrictions concerning ECs and the PLCM document
to all applications submitted from 1 April 2020 onwards.
Japan's PACMP pilot program started in April 2018, while China and
Taiwan are in the process of implementation of the ICH Q12 guideline.
Singapore, South Korea, and Brazil have not yet implemented the
guideline. Canada's ICH Q12 Pilot Program - the ICH Q12 Established
Conditions and Post Approval Change Management Protocol Pilot
Program - started in December 2021.
Traditional Variations Process
or PACMP?
Ultimately, if toxicological and/or clinical data are not required as a
result of the site changes being proposed, PACMP could well be the
way to go.
WEBINAR
The Ultimate Guide to Fluid Transfer Systems:
From Selection to Maintenance
October 25th, 2023 * 9 a.m. PT, 12 p.m. ET
Fluid transfer is vital across industries, but it comes with challenges
like material selection, kinking, and contamination. Join us to
master these challenges, ensure safety, and boost efficiency.
In this webinar you'll:
* Gain insight on identifying challenges in fluid transfer systems
across industries
* Learn about solutions to mitigate common issues, from kinking
to contamination concerns
* Hear real-world case studies demonstrating the impact of
optimized fluid transfer on operational success
* Participate in an interactive Q&A session with experts,
addressing your specific questions and concerns
Who should attend:
* Tubing distributors looking to enhance their knowledge
to better communicate with end users
* Engineers, operators and manufacturers looking to
increase fluid transfer efficiency and decrease loss or sunk cost
Register at: https://bit.ly/3ZHsp1f
www.americanpharmaceuticalreview.com |
| 73
The best advice for MAHs looking to streamline their own processes,
improve efficiency, mitigate supply risk, and shorten the time to
market via new facilities, is to embrace this simplified new process
sooner rather than later.
Author Biography
Valeria Grigoriev is a Senior Regulatory Affairs Specialist at
Regulatory Affairs service provider Arriello. Her experience
spans Research and Development and Project Management
for different types of submissions, from initial Due Diligence
to Approval, across Europe, for regulatory activities including new MAA
and Variations (National, DCP and MRP).
Arriello is at the forefront of ICH Q12/PACMP-based finished product
manufacturer site transfer variations management. Over the two
years to March 2023, the company catered for up to 50 finished
product manufacturing site transfer variations, both national and MRP
applications, with submissions successfully performed across the EU and
Eastern Europe.
valeria.grigoriev@arriello.com, https://arriello.com/
PRESENTERS
Shawn Cole
Product Development Manager
NewAge Industries
Kevin Holder
Founder
Hose Holders LLC
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review
»
https://www.arriello.com/ https://bit.ly/3ZHsp1f http://www.americanpharmaceuticalreview.com
APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023
