Seqens eBook - 13
Sourcing Raw Materials for
Chemical Manufacturing: Key Tips
for Qualifying Suppliers
Ed Price, CEO, Seqens CDMO North America
As every Contract Manufacturing Organization (CMO) knows, sourcing
supplier. The questions would address source and quality of raw materials,
raw materials is critical to drug development and can make or break the
efficiency of processes, and evidence of existing quality systems.
chances for successful commercialization. Whether the project requires
Perform on site evaluations. For sources of critical supplies, it's important
off-the-shelf or customized ingredients, cultivating sound, trustworthy
and reliable supplier relationships significantly increases the chances of
minimizing impurities and meeting project timelines.
to perform on-site quality audits of the supplier's facilities, operations and
quality systems. In the event that an on-site audit is not feasible, CMOs
often can accept recent evidence of a quality system inspection by a
Supplier qualification refers to the overall quality management of
regulatory body such as the FDA, European Medicines Agency (EMA) or
outsourced materials and activities as they relate to drug product and API
other as a substitute for its own on-site visit.
manufacturing. It also is part of a regulated Pharmaceutical Quality System
Document the process. The Supplier Qualification process should be
that is required according to Current Good Manufacturing Practices (cGMP),
documented into Standard Operating Procedures reports by trained staff
and ensures the consistent quality and safety of raw materials.
in order to properly perform an evaluation. These procedures may include
Supplier qualification is not only a requirement of cGMP, but it's also
a tiered system of risk assessment for all suppliers.
mandated by the U.S. FDA to ensure that pharmaceutical supply chains
are properly controlled.
Repercussions of Improperly
Qualified Suppliers
Recent FDA Changes Create Challenges
for CMOs
For many years, careful selection and management of suppliers applied
primarily to finished drug product manufacturers as they sourced APIs
When there's a problem in the supply chain, products are not able to
and excipients for their formulations.
meet demand because of a lack of quality raw materials, clinical trials
In recent years, the FDA's thinking on this subject expanded, with particular
can be halted and amended, or program delays arise when the FDA
scrutiny extended further up the supply chain to those providing raw
inspections raise quality control issues - all good reasons to beef up
materials and critical reagents used in the manufacture of APIs.
supplier qualification.
The FDA's requirement that suppliers be qualified earlier and earlier in
Good manufacturing has always been about paying attention to the
the drug synthesis process makes the regulatory burden on CMOs and
details, and by doing so, CMOs minimize the number of issues that can
sponsors exceptionally challenging.
disrupt project completion. Because the stakes are so high, every CMO
Adding to the challenge, producers of commoditized raw materials
should take extra care in selecting and managing suppliers of their raw
materials and outsourced services.
are neither easily reached nor willing to divulge their proprietary
manufacturing processes. It can sometimes take a month to piece
So how can today's CMOs and other drug developers properly qualify
together the information required for a regulatory submission.
suppliers to FDA standards, ensure project timelines and goals are met
In light of the regulatory challenges, it's important to have a deep bench of
and ultimately ensure safe and effective final products?
Best Practices in Qualifying Suppliers
suppliers. We source materials from all over the world, favoring suppliers
who can supply us reliably, at a high level of quality, and who are willing
to provide the information needed for regulatory filings.
Conduct a self-evaluation questionnaire. Prior to selecting suppliers of
Whether or not regulations and enforcements are relaxed by the FDA
goods and services, companies should require each of its suppliers to
in the future, establishing sound and adhered-to supplier qualification
complete a questionnaire, which should provide important information to
processes not only ensure safe and effective drugs, but they makes good
make an initial evaluation regarding the suitability and compliance of the
business sense.
Pharmaceutical Outsourcing |
13
| pharmoutsourcing.com
http://www.pharmoutsourcing.com
Seqens eBook
Table of Contents for the Digital Edition of Seqens eBook
Contents
Seqens eBook - 1
Seqens eBook - Contents
Seqens eBook - 3
Seqens eBook - 4
Seqens eBook - 5
Seqens eBook - 6
Seqens eBook - 7
Seqens eBook - 8
Seqens eBook - 9
Seqens eBook - 10
Seqens eBook - 11
Seqens eBook - 12
Seqens eBook - 13
Seqens eBook - 14
Seqens eBook - 15
Seqens eBook - 16
Seqens eBook - 17
Seqens eBook - 18
Seqens eBook - 19
Seqens eBook - 20
Seqens eBook - 21
Seqens eBook - 22
Seqens eBook - 23
Seqens eBook - 24
Seqens eBook - 25
Seqens eBook - 26
Seqens eBook - 27
Seqens eBook - 28
Seqens eBook - 29
Seqens eBook - 30
Seqens eBook - 31
Seqens eBook - 32
Seqens eBook - 33
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Seqens eBook - 36
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