Infos über Qualitätssicherung
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Concept Heidelberg (http://www.concept-heidelberg.de)
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.
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Pharmaceutical Quality Assurance Resources
(http://members.tripod.com/%7EChristopherMarrs/QualityAssurance.html)
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SPAQA (http://www.spaqa.org) - 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.
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TOPRA (http://www.topra.org) - The Organization for Professionals in Regulatory Affairs
TOPRA is a new, global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector.
Akkreditierung und Zertifizierung
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SAS (http://www.sas.ch) - Schweizerische Akkreditierungsstelle
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 (http://www.sqs.ch/e/framee.htm)- 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.
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ILAC (http://www.ilac.org)- Swiss Association for Quality and Management Systems
ILAC is an international cooperation of laboratory and inspection accreditation bodies formed more than 30 years ago to help remove technical barriers to trade.
Technische Harmonisierung
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METAS (http://www.metas.ch) - Bundesamt für Metrologie
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.
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CEN (http://www.cenorm.be) - 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).
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EURACHEM (http://www.eurachem.org)
Eurachem is 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
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CCQM (http://www.bipm.fr/en/committees/cc/ccqm) -
Consultative Committee for Amount of Substance - Metrology in Chemistry
Present activities concern primary methods for measuring amount of substance, and international comparisons, establishment of international equivalence between national laboratories, and advice to the CIPM (International Committee for Weights and Measures) on matters concerned with metrology in chemistry.
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AOAC INTERNATIONAL (http://www.aoac.org)
AOAC INTERNATIONAL is committed to be a proactive, worldwide provider and facilitator in the development, use, and harmonization of validated analytical methods and laboratory quality assurance programs and services. Also, to serve as the primary resource for timely knowledge exchange, networking, and high-quality laboratory information for its members.
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CITAC (http://www.citac.cc) - Co-Operation on International Traceability in Analytical Chemistry
CITAC aims to foster collaboration between existing organisations to improve the international comparability of chemical measurement.
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NMS (http://www.nmschembio.org.uk) - 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.
Konformitätserklärung für Produkte
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CEN - Conformity Assessment
(http://www.cen.eu/cen/Services/ConformityAssessment/Pages/default.aspx) - UK National Measurement System
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.
GCP, GLP, GMP
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DGGF (http://www.dggf.de) - 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).
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European Pharmacopeia (http://online.edqm.eu/entry.htm)
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FDA: Current Good Manufacturing Practice (CGMP) Regulations
(http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm) - 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 (http://www.gmptrends.com/index.html)
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.
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ICH (http://www.ich.org) -
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.
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United States Pharmacopeial Convention (http://www.usp.org)
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.
ISO
- ISO (http://www.iso.ch) - International Organization for Standardization
Medikamente
- Swissmedic (http://www.swissmedic.ch) - Schweizerisches Heilmittelinstitut
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.
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MHRA (http://www.mhra.gov.uk) - 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.
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EMA (http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp) -
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.
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EDQM (http://www.edqm.eu) - European Directorate for the Quality of Medicines & Healthcare
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.
Umwelt
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EPA - Pestizide (http://www.epa.gov/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.
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EPA - Substances and toxics (http://www.epa.gov/lawsregs/topics/#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.
