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www.pharmacopoeia.org.uk
This
link is directed to the homepage of the British Pharmacopoeia.
Registered users can log onto the British Pharmacopoeia online.
From this homepage information can also be found on how to register
and how to order BP documents. |
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www.access.gpo.gov
This
link allows a search for a Code of Federal Regulations (CFR).
The Code of Federal Regulations (CFR) is a codification of the
general and permanent rules published in the Federal Register
by the Executive departments and agencies of the Federal Government.
For example,
21 CFR Part 211 covers current Good Manufacturing Practice
utilized in the pharmaceutical industry. |
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www.pheur.org
This
link is directed to the homepage of the European Pharmacopoeia.
It provides information concerning EP news, activities, and upcoming
European conferences. There are also downloadable catalogs listing
publications and reference materials that may be ordered. |
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www.fda.gov
This
link to the United States Food and Drug Administration provides
information concerning FDA news, safety alerts, new product approvals,
recalls, etc. The FDA’s pharmaceutical interests are divided
into two sections: CDER
oversees the research, development, manufacture and marketing
of drugs while the CBER
mission is to protect and enhance the public health through regulation
of biological products including blood, vaccines, therapeutics
and related drugs and devices. Access CDER’s
Regulatory Guidance site or CBER’s
Regulatory Guidance site to view and download specific documentation. |
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www.fda.gov/oc/industry
This
website provides direct links to: guidance documents, inspection
references, information on imports, warning letters and other
FDA enforcement activities. This site also provides easy access
to the regulatory industry where companies can contact the FDA
with questions, submit comments online about proposed FDA regulations
and register to attend specific industry meetings. |
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www.fda.gov
This
link is directed to the homepage of the Freedom of Information
portion of the FDA website. It provides general information about
FOI as well as Index search options and how to request information.
Any information that is routinely available to the public and
not found on the FDA's website may be requested. For instructions
on how to submit a request for information, click on the following
link: www.fda.gov.
Visit the Index
of Electronic Reading Room Documents to review the categories
of frequently requested FDA documents and to view a list of specific
FOI sites that have been established by various government agencies. |
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www.fda.gov
This
Web page is designed to simplify the search for Warning Letters,
which are in PDF format. Browse Warning Letters using one of the
following five categories: most recent, by company, by subject,
by issuing office, by date; and search warning letters with search
form. |
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www.mhra.gov.uk
This
link is directed to the Good Laboratory Practice Regulation document
in PDF format from the MHRA. It can be screen viewed or printed. |
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www.iest.org
The
Institute of Environmental Sciences and Technology, founded in
1953 as a not-for-profit association, is a multidisciplinary,
international society whose members are internationally recognized
for their contributions to the environmental sciences in the areas
of contamination control, electronics manufacturing, and pharmaceutical
processes. IEST is the Secretariat for ISO Technical Committee
209 charged with writing a series of international standards for
clean rooms and associated controlled environments. ISO/DIS 14644-7
on Separative Enclosures can be ordered
on the IEST web site. |
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www.jettconsortium.com
JETT
is a consortium of pharmaceutical manufacturers, equipment suppliers,
and consultants seeking to improve communications between Users
and Suppliers to more effectively meet the "validation" requirements
of the pharmaceutical industry. The goal of JETT is to provide
a common technical language base, bid package formats, and validation
test plan examples that follow GAMP guidelines and to promote
communications between end users and vendors in the pharmaceutical
industry. The site provides sample User Requirements Specification
templates, including one on a production barrier isolator. You can also download
publications
that have been presented at recent pharmaceutical conferences. |
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www.mhra.gov.uk
This site lists the publications that are available and details
on how to obtain them. Clicking on Inspection and Enforcement
Publications will access the Guide to UK GLP Regulations 1999. |
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www.mhra.gov.uk
This
link is directed to the homepage of the United Kingdom's Medicines
Control Agency. It provides general information as well as MCA news
and current events. |
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www.picscheme.org
PIC (Pharmaceutical Inspection Convention) was founded in October
1970 by EFTA (European Free Trade Association) under the title
of "The Convention for the Mutual Recognition of Inspections in
Respect of the Manufacture of Pharmaceutical Products". The initial
members of PIC comprised the 10 member countries of EFTA at that
time. It was realized in the early 1990s that because of an incompatibility
between the Convention and European law, it was not possible for
new countries to be admitted as members of PIC. Consequently,
the PIC Scheme was formed in November 1995. PIC and the PIC Scheme,
which operate together in parallel, are jointly referred to as
PIC/S. You can download
publications that relate to a variety of pharmaceutical manufacturing
and testing issues. |
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www.usp.org
This
link is directed to the homepage of the United States Pharmacopoeia.
It provides some general information including USP news, drug
and dietary supplements, and products. It also provides an online
catalog to order USP 24 and its supplements. Certain chapters
are more relevant to isolation technology than others, such as:
<71> Sterility Tests, <1035> Biological Indicators,
<1116> Microbiological Evaluation of Clean Rooms and Other
Controlled Environments, and <1208> Sterility Testing –
Validation of Isolator Systems. |
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