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Q&A with Capsugel’s Karin Schrooten.
How has the global nutritional market place
Today’s focus on traceability comes at a time when
guaranteeing the safety of the global supply chain has
never been more difficult. Gone are the days when local
raw materials were directly sold to manufacturers, with
few intermediate distributors. In the 21st century, a true
global supply chain exists – along with the need to source
numerous suppliers. Capsugel maintains close direct
contacts with producers for all key raw materials.
Could you talk about Capsugel’s quality
standards as a leading dosage solutions
Capsugel has been making innovative capsule dosage
forms for the nutraceutical and pharmaceutical market
for more than 100 years, and we are one of the world’s
leading purchasers of corresponding key raw materials. The
company has long recognized that the quality of its finished
dosage forms strongly depends on the quality of their
constituents. So we have established a robust quality system
for sourcing raw materials and have built an extensive
knowledge base of international regulatory requirements, all
aimed at safeguarding the integrity of our supply chain and
products. We pride ourselves on setting standards for quality
for the industry.
What actions have you taken to ensure quality
of supply and traceability of raw materials?
Over a decade ago, Capsugel established a Capsule
Supplier Selection and Qualification Program to guarantee
that our hard capsules meet the highest standards for quality,
traceability and integrity. This program requires that critical
raw material suppliers undergo an intensive, year-long
selection and qualification process to make sure they meet
the most stringent regulatory and industry standards.
Could you describe what’s involved in your
supplier qualification process?
Our Capsule Supplier Selection and Qualification Program
is a multi-phase process. First, we begin with a preliminary
investigation of the supplier focusing on source selection
both from supply security and liability. Then we assess
the critical issue of whether the supplier’s raw material is
compatible with our manufacturing processes and protocols.
We follow that up with trials of the supplier’s raw material in
industrial-scale protocols to confirm both finished capsule
quality and manufacturing efficiency performance levels.
One of our most critical steps before certifying a raw
material supplier is the onsite audit. Here we make sure
that the supplier’s material meets all applicable standards,
including those established by IPEC, ISO, IFS, BRC or other
applicable quality standards. We verify in-depth process
controls, testing methodologies, documentation control,
personnel qualifications and upstream traceability, including
certifications and sourcing qualifications of the supplier.
Finally, we move to the acceptance phase that formalizes the
technical and commercial requirements and builds evidence
of consistent quality adherence of subsequent industrial
Do you continue to monitor suppliers after you
Absolutely. Once a supplier has successfully passed our
qualification process, it enters an ongoing evaluation process
that we refer to as our Supplier Performance Management
Capsugel: Setting Standards for Product Integrity in
the Nutraceutical Industry
Recent contamination incidents of food, health and nutrition products have
underlined the importance of safe and traceable raw materials in the health and
nutritional industry. Efforts to tighten regulatory oversight are in place and more
are underway – driven by industry, global regulatory authorities and increasingly,
consumers concerned about the integrity of the food products they purchase.
In fact, a recent survey of 1,500 British consumers regarding food quality
conducted by Mintel in December 2012 and again in March 2013 showed that
consumers rate traceability with increasing importance. Specifically, 14 percent
of consumers surveyed in March 2013 rated the traceability of food and drink as
important compared with only 6 percent in December 2012.
Nutraceuticals Now talks with Capsugel’s Karin Schrooten, Senior Director Global
Quality Operations, about the quality practices the company has established to
protect its global supply chain and ensure product integrity for its customers.
Program. This program is designed to assure supplychain
traceability and finished capsules that fully comply
with regulatory requirements. Importantly, our Supplier
Performance Management Program allows us to maintain
a global network of qualified suppliers with whom we have
established long-term partnerships. This helps to ensure
a safe and uninterrupted supply of raw material. And our
vigilance for quality does not end here. It extends from our
raw materials to manufacturing, packaging and delivery of
finished products to customers.
Further our quality assurance team stays abreast of the
increasingly complex global supply chain and evolving
regulatory quality requirements. That process involves
continuously monitoring industry and governmental
standards, anticipating and rapidly implementing regulatory
changes and participating in membership associations and
Standards for chromium in gelatin were
recently amended. What impact did these
changes have on Capsugel’s quality processes?
Actually, Capsugel was unaffected by this issue, primarily
because of the quality control and quality assurance
programs I’ve just described. Our existing gelatin purchase
specifications already included chromium restrictions when
the incident occurred. So this past April, when the United
States Pharmacopeia-National Formulary monograph for
raw pharmaceutical grade gelatin was revised to include
testing for heavy metals, Capsugel had good news for
our customers: we were able to assure them that we were
already in compliance with the new monograph before it was
What type of feedback have you received from
EU regulatory authorities regarding your efforts
to ensure product safety?
The recent findings from the European Union (EU) Food and
Veterinary Office’s (FVO) inspection of gelatin manufacturers
in India certainly show that our quality control and quality
assurance programs are achieving their goals. The
inspection was carried out as part of the FVO’s effort to
evaluate compliance with EU standards, both within the
EU and in countries that export to the EU. When the FVO
inspected two of Capsugel’s Indian gelatin suppliers in 2012,
both successfully passed inspection. Moreover, the FVO
recognized Capsugel as an important industry representative
with relevant knowledge when considering future regulatory
changes pertaining to gelatin.
How does Capsugel’s commitment to product
integrity help the nutraceutical marketplace?
We strongly believe that staying ahead of the product
integrity curve makes good business sense – and that
establishing a reputation for marketing safe products is
crucial for the health and nutrition industry in general.
Companies that market dietary supplements need to develop
quality guarantee programs that follow globally established
good manufacturing practices (GMPs) so that consumers can
be confident in the products they buy. Moreover, companies
that act proactively will prevent regulatory violations that may
lead to sanctions. So efforts to assure the integrity of our
products are not only good for Capsugel’s reputation but for