PO Q1 2021 - 10

INSIDER INSIGHT

CDMO Audits Should Be a
Key Part of Quality Processes
in Drug Development
How to Conduct a Successful Audit of Your CDMO
Jean-Noel David

Audits are a fact of life in drug development. And, as drug developers
increasingly outsource manufacturing, it's important that the raw
materials used in their final products are monitored to ensure that
they are safe, effective, free of excessive impurities and sourced from
quality suppliers. But while Contract Development & Manufacturing
Organizations (CDMOs) are usually responsible for auditing raw material
suppliers, it's the sponsor's job to audit the CDMO.

Managing Director
Seqens North America CDMO

While most drug manufacturers properly vet their CDMOs to ensure
that they follow current Good Manufacturing Practices (cGMP) across
all operations and conduct regular meetings and correspondence to
ensure that everyone is on the same page, it's still important to conduct
regular audits to revisit key quality criteria.
Not only are supplier audits a good idea, they're also driven by
international regulatory guidance. For example, in the U.S. CFR 211.84
is used by the FDA to outline recommendations for establishing
processes around testing, cleaning equipment and other quality
control guidelines.
To carry out these recommendations most effectively, CDMO audits are
typically held in person, but these are not typical times. The pandemic
has forced companies to delay audits or resort to virtual audits
conducted via video call, or leveraging advanced technologies, such
as AI or Virtual Reality. While in-person audits are essential in critical
industries such as pharmaceuticals, after the pandemic has passed, it's
likely that audits will be conducted less frequently because of the timesavings that virtual audits have enabled.
A good rule of thumb for CDMO audits, however, is to conduct oneto-two per year, usually when the sponsor first begins working with a
CDMO and then about halfway through a project. Many sponsoring
firms leverage experienced consultants to assist with the auditing
process. Consultants can play a major role in conducting the audit, as
well as communicating and collaborating with the CDMO throughout
the project, but it should never replace the involvement of the sponsor,
who often understands first-hand the project and communicates most
frequently with key stakeholders.

Jean-Noel David, who holds an MBA from the
Goizueta Business School at Emory University
in Atlanta and a Master of Science degree
from ENSTA Paris, is the managing director for
Seqens CDMO North America. He is responsible for growing
manufacturing capacity, staff and equipment in North America
and integrating U.S. operations throughout Seqens' 24
manufacturing sites and R&D centers around the world.

Pharmaceutical Outsourcing |

| January/February/March 2021

PO Q1 2021

Table of Contents for the Digital Edition of PO Q1 2021

PO Q1 2021 - Cover1
PO Q1 2021 - Cover2
PO Q1 2021 - 1
PO Q1 2021 - 2
PO Q1 2021 - 3
PO Q1 2021 - 4
PO Q1 2021 - 5
PO Q1 2021 - 6
PO Q1 2021 - 7
PO Q1 2021 - 8
PO Q1 2021 - 9
PO Q1 2021 - 10
PO Q1 2021 - 11
PO Q1 2021 - 12
PO Q1 2021 - 13
PO Q1 2021 - 14
PO Q1 2021 - 15
PO Q1 2021 - 16
PO Q1 2021 - 17
PO Q1 2021 - 18
PO Q1 2021 - 19
PO Q1 2021 - 20
PO Q1 2021 - 21
PO Q1 2021 - 22
PO Q1 2021 - 23
PO Q1 2021 - 24
PO Q1 2021 - 25
PO Q1 2021 - 26
PO Q1 2021 - 27
PO Q1 2021 - 28
PO Q1 2021 - 29
PO Q1 2021 - 30
PO Q1 2021 - 31
PO Q1 2021 - 32
PO Q1 2021 - 33
PO Q1 2021 - 34
PO Q1 2021 - 35
PO Q1 2021 - 36
PO Q1 2021 - 37
PO Q1 2021 - 38
PO Q1 2021 - 39
PO Q1 2021 - 40
PO Q1 2021 - 41
PO Q1 2021 - 42
PO Q1 2021 - 43
PO Q1 2021 - 44
PO Q1 2021 - 45
PO Q1 2021 - 46
PO Q1 2021 - 47
PO Q1 2021 - 48
PO Q1 2021 - Cover3
PO Q1 2021 - Cover4
https://www.nxtbookmedia.com