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Quality
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- Concept
Heidelberg
- European
Commission's Policy Areas
Because of its right of
initiative, the European Commission is charged with making proposals
for all new legislation in the European Union. These activities are
laid down in the Treaty and range from trade, industry and social
policies to agriculture, the environment, energy, regional development
and development cooperation.
On this site you can find useful information on chemicals,
pharmaceuticals and cosmetics.
- Pharmaceutical Quality Assurance Resources
- Pharmig
- Vereinigung pharmazeutischer Unternehmen (A)
Die Pharmig ist die
Interessensvertretung der österreichischen
Arzneimittelwirtschaft. Die Mitgliedsfirmen sind auch durch diverse
Fachausschüsse und Arbeitskreise in die Arbeit der Pharmig
aktiv eingebunden.
- 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 new, 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
- Swiss Accreditation Service
The SAS is responsible for all
types of accreditation in areas both legally and not legally regulated.
As a government institution it is based on the Ordinance on the Swiss
Accreditation System and the Notification which came into force in 1991
and was last revised in 1996. According to this ordinance,
accreditation is granted by the director of the Swiss Federal Office of
Metrology and Accreditation (Metas) after a thorough examination
by the SAS and judgment by the Federal Accreditation Commission (AKKO).
This commission, constituted by the Federal Council, consists of nine
representatives of the Swiss industry, the federal and cantonal
authorities as well as the universities.
- SQS
By all adequate means at its
command, SQS promotes and supports the efforts of the economy as well
as of public and private organisations in the sectors of product,
service, process and company quality, in general. In particular, it
supports their competitiveness and productivity by means of:
- Assessment and evaluation of quality and
management systems, with a particular regard to the fulfilment of the
requirements and to the targeted use of specific standards, directives
and rules provided by Switzerland and foreign countries.
- Certificate confirming the fulfilment of the
requirements of the specific standard principles through the issue of a
temporary certificate, called "SQS certificate".
- Evaluations and certifications of conformity,
also in co-operation with approved and notified partners.
- Benchmark, rating and other evaluation services.
- Training courses.
- Holdings in companies which offer, buy, attend to
and sell services in the quality and management sector.
SQS
is working for getting the recognition of its certificates in
Switzerland and abroad and it co-operates with Swiss and foreign
institutions and organisations which follow up identical or similar
interests.
- DAR
- German Accreditation Council
The DAR is a working group
established by the Federal Government, the Ministries of the Federal
German States and the German industry. The tasks of the DAR are:
- to coordinate the activities in the area of
accreditation and recognition of testing and calibration laboratories,
certification and inspection bodies in Germany
- to run a central registration of German
accreditations and recognitions granted
- to represent German interests in national,
European and international organisations dealing with general questions
of accreditation and recognition.
- EA
- European co-operation for Accreditation
European Accreditation (EA)
covers all European conformity assessment activities: Testing and
calibration, inspection, certification of management systems,
certification of products, certification of personnel, environmental
verification under the European Eco-Management and Audit Scheme (EMAS)
regulation.
- ILAC
- International Laboratory Accreditation Cooperation
ILAC is the world's principal
international forum for the development of laboratory accreditation
practices and procedures, the promotion of laboratory accreditation as
a trade facilitation tool, the assistance of developing accreditation
systems, and the recognition of competent test facilities around the
globe.
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- Metas
- Swiss Federal Office of Metrology and Accreditation
The METAS realises and makes
available internationally agreed units and standards. It supervises the
use of measuring instruments in the fields of commerce, transport,
public safety, health and environmental protection. It monitors the
compliance to legal requirements by cantons and authorised bodies, as
well as trains and advises verification experts and verification
agencies. Its services are available to researchers, industry and
commerce. It manages the Swiss Calibration Service (SCS) and operates
the Swiss Accreditation Service (SAS) .
- CEN
- European Committee for Standardization
CEN's mission is to promote
voluntary technical harmonization in Europe in conjunction with
worldwide bodies and its partners in Europe. Harmonization diminishes
trade barriers, promotes safety, allows interoperability of products,
systems and services, and promotes common technical understanding.
- EURACHEM
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
- AOAC
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.
- CITAC
- Co-Operation on International Traceability in Analytical Chemistry
CITAC aims to foster
collaboration between existing organisations to improve the
international comparability of chemical measurement.
- NMS
- UK National Measurement System
The NMS Chemical and Biological
Metrology website provides public access to
the outputs of the NMS Chemical and Biological Metrology programme.
This website replaces the previous VAM website.
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- ConformityAssessment.org
The Web-portal on Conformity
Assessment
- CEN -
Conformity
Assessment
CEN, in co-operation with
CENELEC, provides a comprehensive range of European Standards and other
publications for the implementation and recognition of good conformity
assessment practices, suitable for all forms of first, second and third
party involvement and evaluation, widely used by all interested parties.
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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 and documented 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" (which
relate to the planning, conduct and reporting of so-called "safety
studies" [mainly toxicity studies] with pharmaceuticals, agro-chemicals
and various industrial chemicals) and "Good Clinical Practices, GCP"
(which relate to clinical studies with new pharmaceutical products).
- European
Pharmacopoeia
- FDA
- Food and Drug Administration (USA)
Current Good Manufacturing Practice (CGMP)
Regulations
- FDA
- Food and Drug Administration (USA)
Guidance Documents
FDA's mission is to promote and
protect the public health by helping safe and effective products reach
the market in a timely way, and monitoring products for continued
safety after they are in use.
The Guidance documents represent the Agency's current thinking on a
particular subject. They do not create or confer any rights for or on
any person and do not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute, regulations, or both.
- GMP
Trends
GMP TRENDS® is an
information letter published specifically for the pharmaceutical,
medical device and related industries. Significant observations made by
FDA Investigators during GMP plant inspections are edited and published
in GMP TRENDS®. These edited excerpts, from actual FD483
observation reports, are published twice a month.
The manufacturing of pharmaceutical preparations and medical device
products are controlled by the FDA under a set of guidelines which are
called the Good Manufacturing Practice Regulations (GMP's).
Awareness of how the FDA is interpreting and enforcing various aspects
of the current regulations is a necessity for those responsible for GMP
compliance.
The language used in the GMP Regulations is both broad and subjective.
This problem is magnified by the latitude and independence given each
FDA District and Individual Investigator.
By publishing edited excerpts from actual FD483 inspection reports by
FDA investigators GMP TRENDS® enables quality assurance
personnel and quality minded executives to interpret the breadth and
scope of the GMP Regulations.
- ICH -
International Conference on Harmonisation
The International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) is a unique project that brings
together the regulatory authorities of Europe, Japan and the United
States and experts from the pharmaceutical industry in the three
regions to discuss scientific and technical aspects of product
registration.
The purpose is to make recommendations on ways to achieve greater
harmonisation in the interpretation and application of technical
guidelines and requirements for product registration in order to reduce
or obviate the need to duplicate the testing carried out during the
research and development of new medicines. The objective of such
harmonisation is a more economical use of human, animal and material
resources, and the elimination of unnecessary delay in the global
development and availability of new medicines whilst maintaining
safeguards on quality, safety and efficacy, and regulatory obligations
to protect public health.
- U.S.
Pharmacopoeia
USP establishes
state-of-the-art standards to ensure the quality of medicines for human
and veterinary use. USP also develops authoritative information about
the appropriate use of medicines. National health care practitioner
reporting programs support USP's standards and information programs. In
addition, USP supports many public service programs.
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- ISO -
International Organization for Standardization
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- IFAH
(formerly COMISA)
IFAH's goal is a harmonised,
science-based regulatory and trade framework that supports a global
animal health industry which is economically viable and high-technology
driven, contributing to a healthy and safe food supply. To fulfill that
goal, its mission is
- To act as the voice of the industry in dialogue
with the major international bodies which have an impact on the animal
health industry (FAO, WHO, Codex, OIE, WTO and others);
- To encourage and assist the development of
predictable science-based regulatory processes and standards;
- To represent the industry with a unified, global
voice in liaisons with governments, food industry partners and the
consumer;
- To facilitate the process of international
harmonisation of regulatory and registration requirements.
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- Swissmedic
- Swiss Agency for Therapeutic Products
Swissmedic, the Swiss Agency
for Therapeutic Products, ensures that only high-quality, safe and
effective medicines and medical devices are placed on the market in
Switzerland. Replaces the IKS (Interkantonale Kontrollstelle
für Heilmittel).
- MHRA
- Medicines and Healthcare products Regulatory Agency (UK)
The Executive Agency of the
Department of Health protecting and promoting public health and patient
safety by ensuring that medicines, healthcare products and medical
equipment meet appropriate standards of safety, quality, performance
and effectiveness, and are used safely.
- EMEA
- European Agency for the Evaluation of Medicinal Products
- European
Directorate for the Quality of Medicines & Healthcare
- FDA
- Food and Drug Administration (USA)
FDA's mission is to promote and
protect the public health by helping safe and effective products reach
the market in a timely way, and monitoring products for continued
safety after they are in use.
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- Environmental
Protection Agency (USA) - Pesticides
Pesticide Registration
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