In 2002, the U.S. Food and Drug Administration (FDA) announced a sweeping new initiative:
Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century. Through the initiative,
the FDA is modernizing its oversight of pharmaceutical quality and ensuring that pharmaceuticals are
pure, high quality, of sure provenance, correctly identified, and precisely dosed.
FDA Approach is Risk-Based and Science-Based
The initiative emphasizes a risk-based approach ñ applying
more oversight to riskier areas such as complex production
processes or new drug manufacture and less to those areas
with proven methods and strong track records.
Simultaneously, the initiative encourages technology
advances and continuous improvement, and heartily supports companies
that apply modern quality management techniques. The
FDA also has boosted cooperation with international health and
regulatory partners ñ many of whom also are sharpening the focus
of their regulatory outlooks ñ to harmonize pharmaceutical quality
standards across borders.
In sum, pharmaceutical companies concomitantly experience high
scrutiny and high opportunity: regulatory agencies sharpen oversight
while the companies continually assess their own processes
for ways to increase efficiency, introduce innovation, and guard public safety.
Companies Scrutinizing Supplier Methods
Increasingly, pharmaceutical companies wrap the supply chain into
improvement objectives. ìPharmaceutical companies, particularly
in Europe, are asking for more information about, and precision in,
the manufacturing of excipients ñ components of a finished drug
other than active ingredients ñ and of components of medical
devices,î explains Henri Guiraud, Rohm and Haas global business
manager, medical adhesives applications, who says companies in Asia and the United States are beginning
to make similar requests. ìWe are very committed to fully satisfying these and future requirements for the
products we supply.î
Alliance and cGMP Efforts Signal Commitment
A&S recently entered a high-profile alliance with Dow Corning and has instituted important cGMP principles in its medical adhesives manufacturing.
Finalized in October 2003, the alliance combines Rohm and Haasí acrylic, polyurethane, polyester expertise
with Dow Corningís silicone-based skills to provide innovative solutions in drug delivery, wound care,
and medical device applications. Dow Corning markets a broad
set of standard and custom solutions. ìWe now have an
unmatched ability to produce and market hybrid products,î
remarks Guiraud, ìas both companies intimately understand the details of these technologies.î
Applying cGMP to Medical Adhesive Manufacturing
Rohm and Haas commenced its cGMP efforts by conducting
thorough audits of its Bremen, Germany medical adhesives
manufacturing process with Dow Corning, A&S representatives,
and cGMP consultants. The audits evaluated critical cGMP principles, including but not limited to:
- raw material source/incoming inspection and approval
- material traceability and status throughout the supply chain
- contamination/cross-contamination prevention
- control of manufacturing process
- change control and customer notification of change
- product labeling as well as repackaging/relabeling controls
The teams identified action items and, since that time, have closed critical gaps in warehousing, traceability,
manufacturing processes, and other areas. ìWe expect to close the few remaining gaps, such as
process and equipment validation, soon,î comments Bernd Perplies, Bremen QC/QA manager.
As part of the cGMP process, the company also consolidated its U.S. medical adhesives manufacturing
into a single plant that is already in line with cGMP principles. ìThese are sensitive applications that require
a high degree of operator training and protection against contamination,î adds Irena Ziec, Rohm and Haas
regulatory EHS and process engineer. ìWe believe that a specialized environment is essential to producing
safe, pure, and effective products.î
Medical Adhesives Customers Reap Benefits
Customers gain a new level of confidence in the suitability of Rohm and Haasí excipients and medical
device components. ìOur products and services are carefully controlled to meet customer needs, and we
are studying regulatory trends to ensure that we meet future requirements quickly and completely,î says
Guiraud, who believes Rohm and Haasí cGMP experience in this business may apply to other areas with
cGMP requirements, such as packaging. Further, Guiraud adds, the company possesses an in-depth understanding
of current and likely future regulations ñ knowledge that it shares with its customers.
As a global company, Rohm and Haas is uniquely equipped to serve the worldwide pharmaceutical industry.
Accordingly, it is deeply engaged in exploring new opportunities, serving customers more seamlessly,
and creating new products. Two signs of things to come? The business expects to roll out ready-to-coat
PSAs soon and is evaluating a promising wound care protective film.
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