Important QA authorities for cell culture under GMP
ECDC - European Centre for Disease Prevention and Control
The ECDC was established in 2005 and is an EU agency aimed at strengthening Europe's defences against infectious diseases. It is seated in Stockholm, Sweden. ECDC's major role is to identify, assess and communicate current and emerging threats to human health posed by infectious diseases.
For cell culture under GMP, the EDCD is less important but its a a valuable source of information about the threats of antibiotic-resistant bacteria. The control and awareness of these is extremely important in hospitals and for the production ATMP (advanced therapy medicinal products) and TEP (tissue engineering products) .
EDQM -
European Directorate for the Quality of Medicines and Health Care
The EDQM publishes the european pharmacopoeia (Ph.Eur.). Since 2011, the 7th edition is published. Within the year of the new edition, two supplemnets and in the two years after that three supplements are published per year. The Ph.Eur. lists all guidelines for testing of medicines.
Chapters that have extremely high importance for cell culture under GMP are sterility, mycoplasma and virus testing. The Ph.Eur has to be purchased. It is not possible to download separate chapeters or monographs.
EMA - European Medicines Agency
The EMA (till 2011 EMEA) 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. The EMA grants the marketing authorizations for human and veterinary medicines after the companies application has passed a centralized procedure.
Besides this, the EMA has several working parties that deal with new technologies, problems, challenges in the area of medicine development. Important working parties in the area of cell culture under GMP are:
- CHMP - Committee for Medicinal Products for Human Use
- CAT - Committee for Advanced Therapies with the working parties:
- Cell-based products and
- Gene therapy
- CVMP - Commitee for Medicinal Products for Vetinary Use
FDA - US Food and Drug Administration
FDA, besides other functions, is the US agency responsible for granting marketing authorizations for drugs and controlling manufacturers concerning drug safety within the US. In contrast to Germany, within the FDA all "health safety" agencies are lovated under one roof: medicines, food, tobacce, medical devices etc. The most important centers with relation to cell culture under GMP within the FDA are:
PEI - Bundesinstitut für Impfstoffe und Biomedizinische Arzneimittel
The Paul-Ehrlich-Institut is an institution of the Federal Republic of Germany. It reports to the Federal Ministry of Health .
Most of its activities relate to the various duties laid down in German and European medicinal product legislation, such as for example the approval of clinical trials and the marketing authorisation of particular groups of medicinal products. The PEI also sends eyperts to the commitees and working parties of EMA, e.g. the CAT.
Within Germany, the PEI is the most important authority to talk to early in the process of developing cell-based therapies such as TEP (tissue engineering products) or ATMP (advanced therapy medicinal products). They do offer scientific advice within the phase of development which might safe from later problems. The PEI also is a reaserch institution. This is of special importance in the area of cell culture, as research is e.g. aimed at developing fast tests for sterility which will allow to test ATMP and TEP suffieciently fast and reliable.
ReAct - Action on Antibiotic Resistance
ReAct is an institution that is concerned with the fast growing dangers and problems associated with antibiotic reaistance. ReAct mainly is a portal for information, an institution that connects partners and groups, lists cases and statistics and thrieves to increase awareness of the - in fact - threatening problem.
RKI - Robert Koch Institute
The RKI is the central federal German institution responsible for disease control and prevention as well as Public health. Besides this, it is also the central federal reference institution for both applied and response-orientated research. It's central duties are the recognition, prevention and control of diseases, especially infectious diseases.
In the area of cell culture under GMP, RKI is important as it lists "approved disinfectants": Desinfektionsmittel (in German). Besides this, the RKI has several centres. An overview is gives in the RKI organigram.
WHO - World Health Organisation
The WHO connects health agencies and groups around the globe. On the WHO pages, many useful links and reports are found, e.g., reginal and global statistics of diseases, reports about toxicity of chemicals and biozides as well general issue cobcerning health systems and treatment of diseses.
Pharma, drugs and medicine
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