12 BioPharm International
®
Partnerships for Outsourcing eBook May 2024 www.biopharminternational.com
D
rug development companies (sponsors) may
assume a commitment to quality is inherent in
the operations of every contract development
and manufacturing organization (CDMO),
simply because product quality is essential for ensur-
ing patient safety. Certainly, every CDMO professes its
commitment to quality. So, in evaluating potential part-
ners to manufacture a drug or biologic, how can one
accurately assess the CDMO's commitment to quality?
The answer involves conducting a thorough on-site
quality audit, asking the right questions, and request-
ing detailed information. The answers, data, and docu-
ments provided will reveal—by what they contain and
what they omit—whether or not the CDMO has a strong
quality management system and quality culture.
Act like an FDA inspector
A CDMO should welcome an on-site audit of its fa-
cilities and operations as part of the vetting process.
Reluctance to have an audit is a red f lag that some-
thing is wrong.
If the sponsor company is a small start-up or has lim-
ited auditing experience, an experienced firm may be
hired to conduct the inspection, ideally with the partici-
pation of a member of the sponsor's own team.
If the sponsor conducts the inspection, a great way
to ensure all the bases are covered is to follow the FDA
quality system inspection technique that the agency
publishes for use by its own inspectors (1). The FDA guide
describes how inspections should be performed on six
systems—those related to quality, facilities and equip-
ment, materials, production, packaging and labeling,
and laboratory controls. The approach described should
be adopted, and the following key questions should
be asked and cer tain information requested.
What is the structure of the quality team?
A CDMO, like any pharmaceutical manufacturer, must
How to Evaluate a CDMO's
Commitment to Quality
Ania Szymanska
is site head of
Quality at Scorpius
Biomanufacturing.
What do you need to ask during the vetting and
selection process to ensure your clinical or commercial
program won't be derailed by a quality-related problem?
QUALITY
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