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- Concept
Heidelberg
CONCEPT HEIDELBERG ist Europas führender
Weiterbildungs- und
Informationsdienstleister auf dem Gebiet der pharmazeutischen
Qualitätssicherung und Arzneimittelsicherheit. Neben der Entwicklung
und Organisation von Seminaren, Konferenzen und In-house-Schulungen in
11 europäischen Ländern bieten wir auch Beratung, Literatur und
Software zur Umsetzung der regulatorischen Vorgaben in diesem Umfeld
an.
- European
Commission: Policy
The European Commission represents the
general interest of the EU and is the driving force in proposing
legislation (to Parliament and the Council), administering and
implementing EU policies, enforcing EU law (jointly with the Court of
Justice) and negotiating in the international arena.
- Pharmaceutical Quality Assurance Resources
- Pharmig - Verband der
pharmazeutischen Industrie Österreichs
Die Pharmig ist die freiwillige,
parteipolitisch unabhängige Interessenvertretung der österreichischen
pharmazeutischen Industrie und vertritt diese mit einer Stimme auf
nationaler und internationaler Ebene.
- SPAQA
- Swiss Professional Association of Quality Assurance
Die SPAQA wurde 1989 mit dem
Ziel gegründet, interessierten Mitgliedern der
Qualitätssicherung eine Plattform für Erfahrungs- und
Interessensaustausch zu bieten. Ihr Ziel ist es, sich
interdisziplinär und international zu vernetzen. Sie ist offen
für Anregungen und Anliegen aus allen GXP und QA Bereichen.
- TOPRA
- The Organization for Professionals in Regulatory Affairs
TOPRA is a global
organisation for Regulatory Affairs professionals and for those who
have an interest in Regulatory Affairs in the healthcare sector.
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- SAS -
Schweizerische Akkreditierungsstelle / Service d'accréditation suisse /
Servizio di accreditamento svizzero / Swiss
Accreditation Service
The Swiss Accreditation Service examines and
accredites conformity assessment bodies (laboratories, inspection
bodies and certification bodies) according to international standards.
It shall implement the basic principles for the several branches in
collaboration with the interested bodies in Switzerland. Furthermore,
the Swiss Accreditation Service represents the national interests in
international organisations, which are concerned with the accreditation
and - as appropriate - the assays and the conformity assessment.
- SQS - Swiss
Association for Quality and Management Systems
SQS provides certification and assessment
services as well as practice oriented training in form of workshops and
seminars.
- ILAC
- International Laboratory Accreditation Cooperation
ILAC is an international cooperation of
laboratory and inspection accreditation bodies formed more than 30
years ago to help remove technical barriers to trade.
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- METAS
- Bundesamt für Metrologie / Office fédéral de métrologie / Ufficio
federale di metrologia / The Federal Office of Metrology
The Federal Office of Metrology realises and
disseminates internationally harmonised and recognised units of
measurement with the necessary accuracy. It supervises the deployment
of measuring instruments in the fields of commerce, traffic, public
safety, health and environment. METAS supervises the execution of legal
provisions carried out by the cantons and by the authorised
verification offices. METAS delivers various services to the benefit of
society, economy and research.
- CEN
- European Committee for Standardization
CEN is a major provider of European
Standards and technical specifications. It is the only recognized
European organization according to Directive 98/34/EC for the planning,
drafting and adoption of European Standards in all areas of economic
activity with the exeption of electrotechnology (CENELEC) and
telecommunication (ETSI).
- EURACHEM
Welcome to Eurachem, a network of
organisations in Europe having the objective of establishing a system
for the international traceability of chemical measurements and the
promotion of good quality practices. It provides a forum for the
discussion of common problems and for developing an informed and
considered approach to both technical and policy issues. It provides a
focus for analytical chemistry and quality related issues in Europe.
- AOAC INTERNATIONAL
AOAC INTERNATIONAL is an independent,
not-for-profit association founded in 1884. To attain its vision of
"worldwide confidence in analytical results," AOAC serves communities
of the analytical sciences by providing the tools and processes
necessary to develop voluntary consensus standards or technical
standards through stakeholder consensus and working groups in which the
fit-for-purpose and method performance criteria are established and
fully documented. AOAC provides a science-based solution and its
Official Methods of Analysis gives defensibility, credibility, and
confidence in decision-making.
- CITAC
- Co-Operation on International Traceability in Analytical Chemistry
CITAC was created in 1993 with the mission
to improve traceability of the results of chemical measurement
everywhere in the world and to ensure that analytical measurements made
in different countries and/or at different times are comparable
- NMS
- UK National Measurement System
The UK NMS Chemical and Biological Metrology
website provides public access to the outputs of the UK NMS Chemical
and Biological Metrology programme. Outputs from the previous VAM
(Valid Analytical Measurement) and MfB (Measurements for Biotechnology)
programmes can also be found on this website. The NMS Chemical and
Biological Metrology programme is made up of several projects, with LGC
and NPL as the main contractors. The programme aims to develop new
approaches to measurement and standardisation.
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- CEN -
Conformity
Assessment
The purpose of conformity assessment is to
provide confidence that
applicable requirements have been met. Such confidence contributes to
the market acceptance of these products, services and systems.
The generic term conformity assessment includes activities such as
testing, inspection, certification and accreditation.
CEN provides a comprehensive range of European Standards and other
publications for the implementation and recognition of good conformity
assessment practices.
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- DGGF
- German Society for Good Research Practices
The term "Good Research Practices" is used
to describe a mixture of legal requirements and voluntary measures
taken by those involved in research and development studies with
chemical products (particularly, but not only, pharmaceutical products
and agrochemical products) to ensure that the studies are planned,
performed, evaluated, reported and archived in a reliable and
transparent way. This is done so that decisions taken based on the
reports of these studies are soundly based and of high scientific
quality. The term thus covers "Good Laboratory Practices" (GLP), "Good
Clinical Practices" (GCP), "Good Manufacturing Practices" (GMP) and
other related Good Practices (GxP).
- European
Pharmacopeia
- FDA: Current Good
Manufacturing Practice (CGMP) Regulations
- Food and Drug Administration (USA)
FDA ensures the quality of drug
products by
carefully monitoring drug
manufacturers' compliance with its Current Good Manufacturing Practice
(CGMP) regulations. The CGMP regulations for drugs contain minimum
requirements for the methods, facilities, and controls used in
manufacturing, processing, and packing of a drug product. The
regulations make sure that a product is safe for use, and that it has
the ingredients and strength it claims to have.
The approval process for new drug and generic drug marketing
applications includes a review of the manufacturer's compliance with
the CGMP. FDA inspectors determine whether the firm has the necessary
facilities, equipment, and skills to manufacture the new drug for which
it has applied for approval. Decisions regarding compliance with CGMP
regulations are based upon inspection of the facilities, sample
analyses, and compliance history of the firm. This information is
summarized in reports which represent several years of history of the
firms.
FDA can issue a warning letter or initiate other regulatory actions
against a company that fails to comply with Current Good Manufacturing
Practice regulations. Failure to comply can also lead to a decision by
FDA not to approve an application to market a drug.
This web page provides links to resources to help drug manufacturers
comply with the Current Good Manufacturing Practice regulations.
- GMP
Trends
GMP TRENDS® is a unique and objective
newsletter published twice a month to provide the pharmaceutical and
medical device industries with the latest information about GMP issues
and FDA 483 observations. This newsletter is designed to provide you
with an understanding of how FDA inspectors are interpreting and
enforcing various aspects of the current regulations.
- ICH -
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for
Human Use
The ICH is unique in bringing together the
regulatory authorities and pharmaceutical industry of Europe, Japan and
the US to discuss scientific and technical aspects of drug
registration. Since its inception in 1990, ICH has evolved, through its
ICH Global Cooperation Group, to respond to the increasingly global
face of drug development, so that the benefits of international
harmonisation for better global health can be realised worldwide. ICH's
mission is to achieve greater harmonisation to ensure that safe,
effective, and high quality medicines are developed and registered in
the most resource-efficient manner
- United States Pharmacopeial
Convention
The is a scientific nonprofit organization
that sets standards for the identity, strength, quality, and purity of
medicines, food ingredients, and dietary supplements manufactured,
distributed and consumed worldwide. USP’s drug standards are
enforceable in the United States by the Food and Drug Administration,
and these standards are developed and relied upon in more than 130
countries.
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- ISO -
International Organization for Standardization
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- IFAH - International
Federation for Animal Health
The IFAH is the global representative body
of companies engaged in research, development, manufacturing and
commercialisation of veterinary medicines, vaccines and other animal
health products in both developed and developing countries across the
five continents.
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- Swissmedic
- Schweizerisches Heilmittelinstitut / Institut suisse des produits
thérapeutiques / Istituto svizzero per gli agenti terapeutici / Swiss
Agency for Therapeutic Products
We are the Swiss agency for the
authorisation and supervision of therapeutic products. We fulfil our
legal mandate and work with partner authorities on a national and
international basis.
- MHRA
- Medicines and Healthcare products Regulatory Agency (UK)
The MHRA is the government agency which is
responsible for ensuring that medicines and medical devices work, and
are acceptably safe.
- EMA
- European Medicines Agency
The European Medicines Agency is a
decentralised agency of the European
Union, located in London. The Agency is responsible for the scientific
evaluation of medicines developed by pharmaceutical companies for use
in the European Union.
- EDQM - European
Directorate for the Quality of Medicines & Healthcare
The EDQM is a leading organisation that
protects public health by
enabling the development, supporting the implementation, and monitoring
the application of quality standards for safe medicines and their safe
use. Our standards are recognised as a scientific benchmark world-wide.
The European Pharmacopoeia is legally binding in European member states.
Similarly, the EDQM develops guidance and standards in the areas of
blood transfusion, organ transplantations and consumer health issues.
- FDA
- Food and Drug Administration (USA)
FDA is responsible for protecting the public
health by assuring the safety, efficacy and security of human and
veterinary drugs, biological products, medical devices, our nation’s
food supply, cosmetics, and products that emit radiation.
FDA is also responsible for advancing the public health by helping to
speed innovations that make medicines more effective, safer, and more
affordable and by helping the public get the accurate, science-based
information they need to use medicines and foods to maintain and
improve their health. FDA also has responsibility for regulating the
manufacturing, marketing and distribution of tobacco products to
protect the public health and to reduce tobacco use by minors.
Finally, FDA plays a significant role in the Nation’s counterterrorism
capability. FDA fulfills this responsibility by ensuring the security
of the food supply and by fostering development of medical products to
respond to deliberate and naturally emerging public health threats.
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Environment
- EPA - Pesticides
Several laws, including the Toxic Substances
Control Act; Federal
Insecticide, Fungicide, and Rodenticide Act; and Food Quality
Protection Act, mandate EPA’s oversight and regulatory responsibilities
to reduce risks from chemicals used on food and the use of pesticides.
EPA's research program strives prevent and reduce pesticide and
industrial chemical risks to humans, communities and ecosystems.
- EPA - Substances
and Toxics
Under a broad range of federal statutes, EPA gathers health, safety and
exposure data, requires necessary testing, and controls human and
environmental exposures for numerous chemical substances and mixtures.
EPA regulates the production and distribution of commercial and
industrial chemicals in order to ensure that chemicals made available
for sale and use in the United States do not harm human health or the
environment.
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