Inhalation April 2023 7
Learn more and
stay connected
Remember to follow us on Linked
In and visit the PQRI website to
stay informed about ongoing ac
tivities and upcoming events.
Past PQRI webinar recordings are
also available.
PQRI membership is open to any
association interested in the regula
tory and quality issues of pharma
ceutical, biological or combination
products and devices. For ques
tions, contact the PQRI Secretar
iat at PQRISecretariat@pqri.org.
Medicinal Product Development
and Continuous Manufacturing.
Other PQTC activities include ex
ploring artificial intelligence (AI)
applications in continuous process
verification (CPV) and restricted
delivery systems in children's OTC
liquid medications. PQTC's Ele
mental Impurities (EI) Working
Group shared industry experiences
related to implementation of ICH
Q3D, is submitting a paper to the
Journal of Trace Elements and Miner-
als, and participated in a workshop
at Excipient World 2022 to share
its work.
mic Drug Product E&L Working
Group presented at several inter
national conferences and had their
work highlighted in e Medicine
Maker and European Pharmaceu-
tical Review. e Working Group
published two manuscripts:
• Safety Thresholds and Best
Demonstrated Practices for
Extractables and Leachables
in Parenteral Dr ug Prod
ucts
PDA Bookstore, 2022
(https://pqri.org/wpcontent/
uploads/2022/03/PQRI PDP
Recommendation2022.pdf )
• Principles for Management of
Extractables and Leachables
in Ophthalmic Drug Prod
ucts PDA J Pharm Sci Tech
nol 2022 (https://journal.pda.
org/content/early/2022/02/15/
pdajpst.2022.012744)
In 2023, a new DTC Working
Group will delve into the topic of
developing a structured approach to
material qualification and control
for drugdevice or biologic device
combination products.
Product Quality
Technical Committee
(PQTC)
e PQTC held a successful work
shop on Excipient and API Impact
on Continuous Manufacturing
(CM) in May 2022. e workshop
addressed several areas, including
identifying and evaluating excipi
ent and API properties that could
impact the CM process; mitigation
of failure modes; how to design for
excipient and API variability in CM;
how to develop new excipients and
grades designed for CM; and impli
cations for CM of API composites.
In 2023, the PQTC will hold the
Titanium Dioxide (TiO
2
) Work
shop—Global Regulatory and
Technical Challenges, which will
bring together materials suppliers,
the pharmaceutical industry and
regulatory experts to discuss the im
pact of removing titanium dioxide
from solid oral dosage forms. PQRI
will also hold a workshop on Co
processed Excipients to Enhance
