Saturday 1 June 2013

Links to regulatory agencies

Some useful links to pharmacopoeia and regulators.

British Pharmacopoeia

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.

CFR Search

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.

European Pharmacopoeia

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.

Food and Drug Administration

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: CDERoversees 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.

FDA's Industry Resource Center

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.

Freedom of Information

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: 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.

Warning Letter Search

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.

GLP Regulations

This link is directed to the Good Laboratory Practice Regulation document in PDF format from the MHRA. It can be screen viewed or printed.

IEST (Institute of Environmental Sciences and Technology

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.

JETT (Joint Equipment Transition Team)

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.

Information Resources: MHRA Publications

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.

Medicines and Healthcare Products Regulatory Agency (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.

Pharmaceutical Inspection Convention

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.

United States Pharmacopoeia

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.
Posted by Tim Sandle

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