BD Biopharmaceutical Production
BD Biopharmaceutical Production
BD Biopharmaceutical Production
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Exhibit 1<br />
REGULATORY DOCUMENTATION<br />
<strong>BD</strong> prides itself on the investment it has made in regulatory compliance, based on<br />
government agency guidance and customer feedback. Our strong commitment to quality<br />
products, reliably delivered with the appropriate documentation, has resulted in the<br />
provision of the following services.<br />
Certificates of Analysis/Certificates of Origin<br />
Certificates of Analysis (C of A) are available on all production products and include<br />
Certificates of Origin (C of O) when appropriate (see exhibit 1). As a leader in manufacturing<br />
and sourcing meat-based products, <strong>BD</strong> has invested in a very intensive<br />
documentation program.<br />
In order to streamline the communication and transmission of<br />
C of A and C of O information, <strong>BD</strong> operates a Certificates On-line<br />
System on the Internet, 24 hours a day, 7 days a week. With specific<br />
lot number information, you can access certificates on the <strong>BD</strong> web<br />
site at www.bdregdocs.com.<br />
Drug Master Files (DMF)<br />
Change Notification Program<br />
<strong>BD</strong> maintains Drug Master Files (DMF) on certain key proprietary<br />
products used in the manufacture of bio-therapeutics.<br />
A DMF is a submission to the Food and Drug Administration (FDA)<br />
that contains confidential information on the manufacturing, process<br />
and packaging of a raw material used in the production of a<br />
drug. The information contained in the DMF may be used to support<br />
an Investigational New Drug Application (IND). The FDA reviews<br />
DMF information upon written request by the DMF holder in support<br />
of another regulatory application.<br />
For more information on DMF availability and permission to reference,<br />
please contact your local <strong>BD</strong> representative.<br />
<strong>BD</strong> offers an Automated Change Notification Program to customers who require notification<br />
of agreed-upon manufacturing and process changes. The program provides greater<br />
assurances that these changes are occurring under our ISO-certified Quality Systems.<br />
To request a Change Notification Program packet, please e-mail ProductInfo@bd.com.<br />
Certificates of Suitability<br />
<strong>BD</strong> participates in the European Pharmacopeia program for Certificates of Suitability,<br />
for animal derived products. Under the procedure, based on Resolution of the Public<br />
Health Committee (Partial Agreement, Resolution AP-CSP (99) 4), <strong>BD</strong> has applied for<br />
certificates concerning: evaluation of the suitability of the control of the chemical purity<br />
and microbiological quality of the substance according to the corresponding specific<br />
monograph; or the evaluation of reduction of Transmissible Spongiform Encephalopathy<br />
(TSE) risk.<br />
For a complete list of products certified or under application, please contact your<br />
local <strong>BD</strong> representative.<br />
62 <strong>BD</strong> BIOPHARMACEUTICAL PRODUCTION
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